A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Terminated
CT.gov ID
NCT03762681
Collaborator
(none)
55
14
3
15.7
3.9
0.2
Study Details
Study Description
Brief Summary
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers (HV) and participants diagnosed with chronic hepatitis B (CHB).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
55 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Placebo-controlled,Observer-blinded Study, to Evaluate Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of RO7239958 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Actual Study Start Date
:
Dec 14, 2018
Actual Primary Completion Date
:
Apr 6, 2020
Actual Study Completion Date
:
Apr 6, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Single Ascending Dose, HV Healthy volunteers will be administered a single dose of RO7239958 or placebo subcutaneously (SC). |
Drug: RO7239958
Solution for injection, subcutaneous use (SC).
Other: Placebo
Sodium chloride solution for injection, SC
|
| Experimental: Part 2a: Multi-dose, CHB Participants with chronic hepatitis B will be administered different dose levels of RO7239958 or placebo SC. Dosages will be determined from data collected from Part 1. |
Drug: RO7239958
Solution for injection, subcutaneous use (SC).
Other: Placebo
Sodium chloride solution for injection, SC
|
| Experimental: Part 2b: Multi-dose, CHB (Optional) Additional study arm to open based on data collected from Part 2a. Participants with chronic hepatitis B will be administered different doses and frequencies of RO7239958 or placebo SC. |
Drug: RO7239958
Solution for injection, subcutaneous use (SC).
Other: Placebo
Sodium chloride solution for injection, SC
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events (AEs) [Up to approximately 16 months]
An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product (including investigational drug) during the course of a clinical investigation. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease that was temporally associated with the use of the investigational product, regardless of whether it was considered to be related to the investigational product or not.
- Number of Participants With Clinically Significant Changes in Vital Signs [Up to approximately 16 months]
Number of participants with clinically significant abnormalities in vital signs such as systolic and diastolic blood pressure, heart rate, body temperature were evaluated.
- Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings [Up to approximately 16 months]
- Number of Participants With Clinically Significant Changes in Clinical Laboratory Results [Up to approximately 16 months]
Number of participants with clinically significant abnormalities in clinical laboratory parameters such as serum chemistry, hematology, coagulation, viral serology, urinalysis were evaluated.
- Number of Participants With Injection Site Reactions (ISRs) [Up to approximately 16 months]
Injection site reactions (ISRs) referred to any localized sign or symptom, including pain, erythema, swelling and pruritus and were graded as follows: Grade 1: mild, Grade 2: moderate; Grade 3: severe. Adverse events related to ISRs were reported.
Secondary Outcome Measures
- Maximum Plasma Concentration (Cmax) of RO7239958 [Part 1: pre-dose on Day 1 and post-dose at 15 minutes (min), 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 48, 72, 96, 120, 168 hours. Part 2a: pre-dose on Days 1 and 29 and post-dose at 30 min, 1, 2, 4, 6, 8, 24 hours.]
- Time to Cmax (Tmax) of RO7239958 [Part 1: pre-dose on Day 1 and post-dose at 15 minutes (min), 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 48, 72, 96, 120, 168 hours. Part 2a: pre-dose on Days 1 and 29 and post-dose at 30 min, 1, 2, 4, 6, 8, 24 hours.]
- Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of RO7239958 [Part 1: pre-dose on Day 1 and post-dose at 15 minutes (min), 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 48, 72, 96, 120, 168 hours. Part 2a: pre-dose on Days 1 and 29 and post-dose at 30 min, 1, 2, 4, 6, 8, 24 hours.]
- Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of RO7239958 [Part 1: pre-dose on Day 1 and post-dose at 15 minutes (min), 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 48, 72, 96, 120, 168 hours. Part 2a: pre-dose on Days 1 and 29 and post-dose at 30 min, 1, 2, 4, 6, 8, 24 hours.]
- Half-life (t1/2) of RO7239958 [Part 1: pre-dose on Day 1 and post-dose at 15 minutes (min), 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 48, 72, 96, 120, 168 hours. Part 2a: pre-dose on Days 1 and 29 and post-dose at 30 min, 1, 2, 4, 6, 8, 24 hours.]
- Cumulative Amount of Drug Excreted in Urine (Ae) [Part 1: 0-4 h, 0-8 h, 0-12 h and 0-24 h on Day 1; Part 2a: 0-4 h and 0-8 h on Days 1 and 29]
The cumulative amount of drug excreted in urine (Ae) over a 24 hour period or over defined time periods linked to the pools of urine collected was analyzed.
- Part 2a: Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels [Part 2a: Days 1 (pre-dose), 8, 15, 22, 29 (pre-dose); at discontinuation (DC) and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks)]
- Part 2a: Change From Baseline in Hepatitis B Surface Antibody (Anti-HBs) Levels [Part 2a: Days 1 (pre-dose), 8, 15, 22, 29 (pre-dose); at discontinuation (DC) and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks)]
- Part 2a: Number of Participants With HBsAg Loss [Part 2a: Days 1 (pre-dose), 8, 15, 22, 29 (pre-dose); at discontinuation (DC) and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks)]
HBsAg loss was defined as a measurement below the lower limit of sensitivity.
- Part 2a: Number of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss in HBeAg-positive Participants [Part 2a: Days 1 (pre-dose), 8, 15, 22, 29 (pre-dose); at discontinuation (DC) and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks)]
HBeAg loss was defined as a measurement below lower limit of sensitivity. Positive HBeAg is a marker of an actively replicating HBV virus infection.
- Part 2a: Number of Participants With Hepatitis B e Antibody (Anti-HBe) Seroconversion in HBeAg-positive Participants [Part 2a: Days 1 (pre-dose), 8, 15, 22, 29 (pre-dose); at discontinuation (DC) and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks)]
Anti-HbBe was defined as an antibody to HBeAg. Positive HBeAg is a marker of an actively replicating HBV virus infection.
- Part 2a: Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Below the Assay Lower Limit of Quantification [Part 2a: Day 1 (pre-dose), 15, 29 (pre-dose); at discontinuation (DC), rebound and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks)]
Participants with HBV DNA below the assay lower limit of quantification i.e. LLOQ <20 IU/ml at each time-point were analyzed.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
All Parts
-Female participants should be of non-childbearing potential and male participants who are with pregnant partners or partners of childbearing potential must agree to remain abstinent or use contraceptive measures
Part 1 (SAD HV only)
-
Healthy, as judged by the Investigator
-
Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on Day 1, and agrees to remain non-smoker during the study
Part 2 (CHB only)
-
Positive serum HBsAg status for > 6 months prior to screening
-
Serum HBsAg level ≥ 250 IU/mL at screening
-
On stable entecavir or tenofovir (alone or in combination) treatment and having received the same drug in the 3 months prior to randomisation
-
HBV DNA below the lower limit of quantification (LLQ) for ≥ 6 months prior to screening by local testing, and confirmed at screening
-
Screening laboratory values (including hematology, chemistry, urinalysis) within normal ranges
-
No past or current diagnosis of cirrhosis
Exclusion Criteria:
All Parts
-
History or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological disorders, or diagnosed central or peripheral neurological disease, capable of altering the absorption, metabolism, or elimination of drugs, or constituting a risk when taking the study treatment, or of interfering with the interpretation of the data
-
History of lymphoma, leukemia, or malignancy within the past five years
-
Positive for human immunodeficiency virus (HIV) infection
-
Participant under judicial supervision, guardianship or curatorship
Part 1 (SAD HV only)
-
Screening ECG showing clinically relevant abnormalities
-
Abnormal blood pressure
-
History or presence of liver disease, or known hepatic or biliary abnormalities
-
Alanine aminotransferase (ALT) ≥1.5 × upper limit of normal (ULN)
-
Any clinically significant out of range findings in other laboratory test results or any other clinically significant (as judged by the Investigator) abnormalities in the physical examination at screening and on Day -1
-
Positive for hepatitis B surface antigen (HBsAg), or hepatitis B core total antibody [anti-HBc]), or hepatitis C virus (HCV) antibody test result
Part 2 (CHB only)
-
History or presence of bridging fibrosis or cirrhosis or decompensated liver disease
-
History or presence of a medical condition associated with liver disease other than HBV infection. Other known hepatic or biliary abnormalities
-
History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) ≥13 ng/mL
-
History of having received (in the last six months) or currently receiving any systemic antineoplastic (including radiation) or immune-modulatory treatment (including systemic corticosteroids)
-
History of organ transplantation
-
Estimated glomerular filtration rate (eGFR) <70 mL/min/1.73m^2
-
Confirmed QT interval corrected using Fridericia's formula (QTcF) >450 ms
-
Expected to need any other systemic antiviral therapy at any time during participation in the study
-
Positive hepatitis C antibody test
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Acibadem City Clinic Tokuda Hospital Ead | Sofia | Bulgaria | 1407 | |
| 2 | COMAC Medical; Clinical Research Unit for Phase I | Sofia | Bulgaria | 1612 | |
| 3 | Queen Mary Hospital | Hong Kong | Hong Kong | ||
| 4 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
| 5 | Asan Medical Center. | Seoul | Korea, Republic of | 138-736 | |
| 6 | Auckland Clinical Studies Limited | Auckland | New Zealand | 1010 | |
| 7 | ID Clinic | Myslowice | Poland | 41-400 | |
| 8 | Kaohsiung Medical University | Kaohsiung | Taiwan | 807 | |
| 9 | National Cheng Kung University Hospital | Tainan | Taiwan | 70457 | |
| 10 | Western General Hospital | Edinburgh | United Kingdom | EH4 2XU | |
| 11 | Royal Liverpool University Hospital | Liverpool | United Kingdom | L7 8XP | |
| 12 | King College Hospital NHS Foundation Trust | London | United Kingdom | SE5 9RS | |
| 13 | Chelsea & Westminster Hospital | London | United Kingdom | SW10 9NH | |
| 14 | St George's Hospital | London | United Kingdom | SW17 0QT |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT03762681
Other Study ID Numbers:
- NP40520
- 2018-003530-32
First Posted:
Dec 4, 2018
Last Update Posted:
May 11, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | In Part 1 all healthy volunteers were enrolled at 1 center in New Zealand. In Part 2a, participants with chronic hepatitis B (CHB) were enrolled at 7 centers across 5 countries: Bulgaria, United Kingdom, Hong Kong, Korea, and New Zealand. |
|---|---|
| Pre-assignment Detail | Part 1, single ascending dose (SAD), enrolled healthy volunteers. In Part 2a, two doses of RO7239958 at two dose levels were administered in participants with CHB. No additional arms were opened in Part 2a. Part 2B of the study was not conducted due to early termination of the study. |
| Arm/Group Title | Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of placebo subcutaneously (SC). | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Period Title: Part 1 | ||||||||
| STARTED | 8 | 8 | 8 | 8 | 8 | 0 | 0 | 0 |
| COMPLETED | 8 | 8 | 8 | 7 | 8 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Period Title: Part 1 | ||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 2 | 8 | 5 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 2 | 8 | 4 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of placebo subcutaneously (SC). | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Total of all reporting groups |
| Overall Participants | 8 | 8 | 8 | 8 | 8 | 2 | 8 | 5 | 55 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
37.0
(12.7)
|
36.5
(15.1)
|
28.9
(9.1)
|
31.8
(14.1)
|
28.8
(7.2)
|
46.0
(18.4)
|
47.5
(7.4)
|
45.6
(7.3)
|
36.4
(12.7)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
1
12.5%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
3.6%
|
| Male |
7
87.5%
|
8
100%
|
7
87.5%
|
8
100%
|
8
100%
|
2
100%
|
8
100%
|
5
100%
|
53
96.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||
| Hispanic or Latino |
0
0%
|
1
12.5%
|
1
12.5%
|
2
25%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
5
9.1%
|
| Not Hispanic or Latino |
8
100%
|
7
87.5%
|
7
87.5%
|
6
75%
|
8
100%
|
2
100%
|
7
87.5%
|
5
100%
|
50
90.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
25%
|
1
12.5%
|
2
25%
|
1
12.5%
|
0
0%
|
0
0%
|
4
50%
|
1
20%
|
11
20%
|
| Native Hawaiian or Other Pacific Islander |
1
12.5%
|
0
0%
|
0
0%
|
1
12.5%
|
1
12.5%
|
0
0%
|
1
12.5%
|
0
0%
|
4
7.3%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
50%
|
0
0%
|
0
0%
|
1
1.8%
|
| White |
5
62.5%
|
7
87.5%
|
3
37.5%
|
5
62.5%
|
6
75%
|
0
0%
|
3
37.5%
|
4
80%
|
33
60%
|
| More than one race |
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
1
12.5%
|
1
50%
|
0
0%
|
0
0%
|
3
5.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
2
25%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
5.5%
|
Outcome Measures
| Title | Number of Participants With Adverse Events (AEs) |
|---|---|
| Description | An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product (including investigational drug) during the course of a clinical investigation. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease that was temporally associated with the use of the investigational product, regardless of whether it was considered to be related to the investigational product or not. |
| Time Frame | Up to approximately 16 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. |
| Arm/Group Title | Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of placebo subcutaneously (SC). | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 2 | 8 | 5 |
| Count of Participants [Participants] |
7
87.5%
|
3
37.5%
|
4
50%
|
7
87.5%
|
5
62.5%
|
1
50%
|
4
50%
|
1
20%
|
| Title | Number of Participants With Clinically Significant Changes in Vital Signs |
|---|---|
| Description | Number of participants with clinically significant abnormalities in vital signs such as systolic and diastolic blood pressure, heart rate, body temperature were evaluated. |
| Time Frame | Up to approximately 16 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. |
| Arm/Group Title | Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of placebo subcutaneously (SC). | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 2 | 8 | 5 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings |
|---|---|
| Description | |
| Time Frame | Up to approximately 16 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. |
| Arm/Group Title | Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of placebo subcutaneously (SC). | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 2 | 8 | 5 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Clinically Significant Changes in Clinical Laboratory Results |
|---|---|
| Description | Number of participants with clinically significant abnormalities in clinical laboratory parameters such as serum chemistry, hematology, coagulation, viral serology, urinalysis were evaluated. |
| Time Frame | Up to approximately 16 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. |
| Arm/Group Title | Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of placebo subcutaneously (SC). | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 2 | 8 | 5 |
| Absolute Neutrophil Count, Low (<10^9/L) |
1
12.5%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
1
50%
|
0
0%
|
0
0%
|
| Alanine Transaminase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT), High |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
25%
|
0
0%
|
0
0%
|
0
0%
|
| Aspartate Aminotransferase (AST) or Serum Glutamic-Oxaloacetic Transaminase (SGOT), High |
1
12.5%
|
1
12.5%
|
1
12.5%
|
1
12.5%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Injection Site Reactions (ISRs) |
|---|---|
| Description | Injection site reactions (ISRs) referred to any localized sign or symptom, including pain, erythema, swelling and pruritus and were graded as follows: Grade 1: mild, Grade 2: moderate; Grade 3: severe. Adverse events related to ISRs were reported. |
| Time Frame | Up to approximately 16 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. |
| Arm/Group Title | Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of placebo subcutaneously (SC). | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 2 | 8 | 5 |
| Count of Participants [Participants] |
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
| Title | Maximum Plasma Concentration (Cmax) of RO7239958 |
|---|---|
| Description | |
| Time Frame | Part 1: pre-dose on Day 1 and post-dose at 15 minutes (min), 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 48, 72, 96, 120, 168 hours. Part 2a: pre-dose on Days 1 and 29 and post-dose at 30 min, 1, 2, 4, 6, 8, 24 hours. |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK population included all study participants who received active treatment unless there were significant violations of inclusion or exclusion criteria, or if data were unavailable or insufficient to allow for full analysis. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 5 |
| Day 1 |
5.93
(1.37)
|
19.9
(5.65)
|
102
(43.7)
|
166
(64.8)
|
9.21
(1.69)
|
21.2
(2.96)
|
| Day 29 |
8.81
(3.51)
|
19.3
(2.77)
|
| Title | Time to Cmax (Tmax) of RO7239958 |
|---|---|
| Description | |
| Time Frame | Part 1: pre-dose on Day 1 and post-dose at 15 minutes (min), 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 48, 72, 96, 120, 168 hours. Part 2a: pre-dose on Days 1 and 29 and post-dose at 30 min, 1, 2, 4, 6, 8, 24 hours. |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK population included all study participants who received active treatment unless there were significant violations of inclusion or exclusion criteria, or if data were unavailable or insufficient to allow for full analysis. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 5 |
| Day 1 |
1.75
|
2.00
|
2.00
|
2.00
|
1.00
|
1.00
|
| Day 29 |
2.00
|
2.00
|
| Title | Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of RO7239958 |
|---|---|
| Description | |
| Time Frame | Part 1: pre-dose on Day 1 and post-dose at 15 minutes (min), 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 48, 72, 96, 120, 168 hours. Part 2a: pre-dose on Days 1 and 29 and post-dose at 30 min, 1, 2, 4, 6, 8, 24 hours. |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK population included all study participants who received active treatment unless there were significant violations of inclusion or exclusion criteria, or if data were unavailable or insufficient to allow for full analysis. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 5 |
| Day 1 |
34.5
(3.07)
|
106
(26.4)
|
508
(152)
|
868
(230)
|
59.4
(17.7)
|
153
(22.1)
|
| Day 29 |
63.9
(24.6)
|
161
(10.1)
|
| Title | Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of RO7239958 |
|---|---|
| Description | |
| Time Frame | Part 1: pre-dose on Day 1 and post-dose at 15 minutes (min), 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 48, 72, 96, 120, 168 hours. Part 2a: pre-dose on Days 1 and 29 and post-dose at 30 min, 1, 2, 4, 6, 8, 24 hours. |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK population included all study participants who received active treatment unless there were significant violations of inclusion or exclusion criteria, or if data were unavailable or insufficient to allow for full analysis. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 5 |
| Day 1 |
33.9
(3.07)
|
98.4
(22.6)
|
481
(150)
|
819
(227)
|
54.9
(11.5)
|
125
(15.9)
|
| Day 29 |
58.0
(19.9)
|
119
(5.36)
|
| Title | Half-life (t1/2) of RO7239958 |
|---|---|
| Description | |
| Time Frame | Part 1: pre-dose on Day 1 and post-dose at 15 minutes (min), 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 30, 36, 48, 72, 96, 120, 168 hours. Part 2a: pre-dose on Days 1 and 29 and post-dose at 30 min, 1, 2, 4, 6, 8, 24 hours. |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK population included all study participants who received active treatment unless there were significant violations of inclusion or exclusion criteria, or if data were unavailable or insufficient to allow for full analysis. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 5 |
| Day 1 |
5.36
|
151
|
411
|
515
|
3.13
|
499
|
| Day 29 |
3.04
|
231
|
| Title | Cumulative Amount of Drug Excreted in Urine (Ae) |
|---|---|
| Description | The cumulative amount of drug excreted in urine (Ae) over a 24 hour period or over defined time periods linked to the pools of urine collected was analyzed. |
| Time Frame | Part 1: 0-4 h, 0-8 h, 0-12 h and 0-24 h on Day 1; Part 2a: 0-4 h and 0-8 h on Days 1 and 29 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) population included all study participants who received active treatment unless there were significant violations of inclusion or exclusion criteria, or if data were unavailable or insufficient to allow for full analysis. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 8 | 8 | 8 | 8 | 8 | 5 |
| Day 1, accumulation interval 0- 4 h |
16.4
(8.87)
|
35.4
(33.7)
|
104
(72.6)
|
290
(272)
|
25.0
(14.1)
|
81.9
(125)
|
| Day 1, accumulation interval 0-8 h |
23.1
(12.3)
|
50.1
(48.2)
|
153
(76.0)
|
446
(359)
|
35.2
(22.3)
|
127
(170)
|
| Day 1, accumulation interval 0-12 h |
23.5
(16.5)
|
51.2
(51.0)
|
172
(81.3)
|
474
(379)
|
||
| Day 1, accumulation interval 0-24 h |
23.8
(20.0)
|
51.7
(55.9)
|
189
(92.1)
|
497
(383)
|
||
| Day 29, accumulation interval 0-4 h |
23.4
(14.5)
|
46.4
(44.4)
|
||||
| Day 29, accumulation interval 0-8 h |
38.1
(23.3)
|
85.1
(56.9)
|
| Title | Part 2a: Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels |
|---|---|
| Description | |
| Time Frame | Part 2a: Days 1 (pre-dose), 8, 15, 22, 29 (pre-dose); at discontinuation (DC) and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|
| Arm/Group Description | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 2 | 8 | 5 |
| Baseline |
3.66
(0.50)
|
3.52
(0.61)
|
3.22
(0.38)
|
| Change at Day 8 |
-0.20
(0.44)
|
-0.05
(0.18)
|
-0.13
(0.16)
|
| Change at Day 15 |
-0.20
(0.27)
|
-0.05
(0.31)
|
-0.13
(0.17)
|
| Change at Day 22 |
-0.40
(0.40)
|
-0.05
(0.12)
|
-0.17
(0.23)
|
| Change at Day 29 |
-0.06
(0.19)
|
-0.09
(0.11)
|
-0.08
(0.23)
|
| Change at Day 43 |
0.04
(0.02)
|
-0.11
(0.35)
|
-0.26
(0.33)
|
| Change at Day 57 |
0.05
(0.01)
|
-0.12
(0.30)
|
-0.19
(0.26)
|
| Change at Day 85 |
-0.01
(0.09)
|
-0.14
(0.24)
|
-0.06
(0.08)
|
| Change at Day 113 |
0.23
(NA)
|
-0.03
(0.09)
|
-0.05
(0.09)
|
| Title | Part 2a: Change From Baseline in Hepatitis B Surface Antibody (Anti-HBs) Levels |
|---|---|
| Description | |
| Time Frame | Part 2a: Days 1 (pre-dose), 8, 15, 22, 29 (pre-dose); at discontinuation (DC) and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|
| Arm/Group Description | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 2 | 8 | 5 |
| Baseline |
0.48
(0.00)
|
0.50
(0.08)
|
0.48
(0.00)
|
| Change at Day 8 |
0.00
(0.00)
|
0.02
(0.05)
|
0.00
(0.00)
|
| Change at Day 15 |
0.00
(0.00)
|
0.00
(0.00)
|
0.00
(0.00)
|
| Change at Day 22 |
0.00
(0.00)
|
0.02
(0.06)
|
0.00
(0.00)
|
| Change at Day 29 |
0.00
(0.00)
|
0.01
(0.04)
|
0.00
(0.00)
|
| Change at Day 43 |
0.00
(0.00)
|
0.02
(0.05)
|
0.00
(0.00)
|
| Change at Day 57 |
0.00
(0.00)
|
0.02
(0.06)
|
0.00
(0.00)
|
| Change at Day 85 |
0.00
(0.00)
|
0.02
(0.07)
|
0.00
(0.00)
|
| Change at Day 113 |
0.00
(NA)
|
0.02
(0.06)
|
0.00
(0.00)
|
| Title | Part 2a: Number of Participants With HBsAg Loss |
|---|---|
| Description | HBsAg loss was defined as a measurement below the lower limit of sensitivity. |
| Time Frame | Part 2a: Days 1 (pre-dose), 8, 15, 22, 29 (pre-dose); at discontinuation (DC) and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. |
| Arm/Group Title | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|
| Arm/Group Description | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 2 | 8 | 5 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
| Title | Part 2a: Number of Participants With Hepatitis B Envelope Antigen (HBeAg) Loss in HBeAg-positive Participants |
|---|---|
| Description | HBeAg loss was defined as a measurement below lower limit of sensitivity. Positive HBeAg is a marker of an actively replicating HBV virus infection. |
| Time Frame | Part 2a: Days 1 (pre-dose), 8, 15, 22, 29 (pre-dose); at discontinuation (DC) and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|
| Arm/Group Description | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 0 | 3 | 0 |
| HBeAg Loss at Baseline |
0
0%
|
||
| HBeAg Loss at Day 8 |
0
0%
|
||
| HBeAg Loss at Day 15 |
0
0%
|
||
| HBeAg Loss at Day 22 |
0
0%
|
||
| HBeAg Loss at Day 29 |
0
0%
|
||
| HBeAg Loss at Day 43 |
0
0%
|
||
| HBeAg Loss at Day 57 |
0
0%
|
||
| HBeAg Loss at Day 85 |
0
0%
|
||
| HBeAg Loss at Day 113 |
0
0%
|
| Title | Part 2a: Number of Participants With Hepatitis B e Antibody (Anti-HBe) Seroconversion in HBeAg-positive Participants |
|---|---|
| Description | Anti-HbBe was defined as an antibody to HBeAg. Positive HBeAg is a marker of an actively replicating HBV virus infection. |
| Time Frame | Part 2a: Days 1 (pre-dose), 8, 15, 22, 29 (pre-dose); at discontinuation (DC) and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|
| Arm/Group Description | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 0 | 3 | 0 |
| Anti-HBe Seroconversion at Baseline |
0
0%
|
||
| Anti-HBe Seroconversion at Day 8 |
0
0%
|
||
| Anti-HBe Seroconversion at Day 15 |
0
0%
|
||
| Anti-HBe Seroconversion at Day 22 |
0
0%
|
||
| Anti-HBe Seroconversion at Day 29 |
0
0%
|
||
| Anti-HBe Seroconversion at Day 43 |
0
0%
|
||
| Anti-HBe Seroconversion at Day 57 |
0
0%
|
||
| Anti-HBe Seroconversion at Day 85 |
0
0%
|
||
| Anti-HBe Seroconversion at Day 113 |
0
0%
|
| Title | Part 2a: Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Below the Assay Lower Limit of Quantification |
|---|---|
| Description | Participants with HBV DNA below the assay lower limit of quantification i.e. LLOQ <20 IU/ml at each time-point were analyzed. |
| Time Frame | Part 2a: Day 1 (pre-dose), 15, 29 (pre-dose); at discontinuation (DC), rebound and at follow-up visits 14, 28, 56, and 84 days after the last dose of study drug (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all study participants who received at least one dose of RO7239958 or placebo. Data are reported for participants HBeAg positive or negative at baseline. Number analyzed is the number of participants with data available for analyses. |
| Arm/Group Title | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 |
|---|---|---|---|
| Arm/Group Description | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. |
| Measure Participants | 2 | 8 | 5 |
| HBeAg+: Baseline |
3
37.5%
|
||
| HBeAg-: Baseline |
2
25%
|
5
62.5%
|
5
62.5%
|
| HBeAg+: Day 15 |
3
37.5%
|
||
| HBeAg-: Day 15 |
2
25%
|
4
50%
|
5
62.5%
|
| HBeAg+: Day 29 |
3
37.5%
|
||
| HBeAg-: Day 29 |
2
25%
|
5
62.5%
|
5
62.5%
|
| HBeAg+: Day 43 |
2
25%
|
||
| HBeAg-: Day 43 |
2
25%
|
5
62.5%
|
5
62.5%
|
| HBeAg+: Day 57 |
3
37.5%
|
||
| HBeAg-: Day 57 |
2
25%
|
5
62.5%
|
4
50%
|
| HBeAg+: Day 85 |
3
37.5%
|
||
| HBeAg-: Day 85 |
2
25%
|
5
62.5%
|
4
50%
|
| HBeAg+: Day 113 |
3
37.5%
|
||
| HBeAg-: Day 113 |
1
12.5%
|
4
50%
|
4
50%
|
Adverse Events
| Time Frame | Up to approximately 16 months | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population included all study participants who received at least one dose of RO7239958 or placebo. | |||||||||||||||
| Arm/Group Title | Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 | ||||||||
| Arm/Group Description | Healthy volunteers were administered a single dose of placebo subcutaneously (SC). | Healthy volunteers were administered a single dose of 0.1 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 0.3 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.0 mg/kg RO7239958 SC. | Healthy volunteers were administered a single dose of 1.5 mg/kg RO7239958 SC. | Participants with chronic hepatitis B (CHB) were administered two doses of placebo SC at a dosing frequency of once every four weeks (Q4W). | Participants with CHB were administered two doses of 0.2 mg/kg RO7239958 SC at a dosing frequency of Q4W. | Participants with CHB were administered two doses of 0.4 mg/kg RO7239958 SC at a dosing frequency of Q4W. | ||||||||
All Cause Mortality |
||||||||||||||||
| Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/2 (0%) | 0/8 (0%) | 0/5 (0%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/2 (0%) | 0/8 (0%) | 0/5 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Part 1, Cohorts 1-4: Placebo | Part 1, Cohort 1: 0.1 mg/kg RO7239958 | Part 1, Cohort 2: 0.3 mg/kg RO7239958 | Part 1, Cohort 3: 1.0 mg/kg RO7239958 | Part 1, Cohort 4: 1.5 mg/kg RO7239958 | Part 2a: Placebo | Part 2a, Arm 1: 0.2 mg/kg RO7239958 | Part 2a, Arm 2: 0.4 mg/kg RO7239958 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/8 (87.5%) | 3/8 (37.5%) | 4/8 (50%) | 7/8 (87.5%) | 5/8 (62.5%) | 1/2 (50%) | 4/8 (50%) | 1/5 (20%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Abdominal discomfort | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Abdominal pain upper | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Gingival bleeding | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| General disorders | ||||||||||||||||
| Catheter site bruise | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 1/8 (12.5%) | 1 | 0/5 (0%) | 0 |
| Catheter site inflammation | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Catheter site paraesthesia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Fatigue | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 1/5 (20%) | 1 |
| Influenza like illness | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 1/5 (20%) | 1 |
| Injection site reaction | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 1/8 (12.5%) | 1 | 0/5 (0%) | 0 |
| Medical device site dermatitis | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Pyrexia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 1/8 (12.5%) | 2 | 0/5 (0%) | 0 |
| Vessel puncture site bruise | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Infections and infestations | ||||||||||||||||
| Upper respiratory tract infection | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/2 (50%) | 1 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Viral infection | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||
| Arthropod bite | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Contusion | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 3/8 (37.5%) | 4 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Ligament sprain | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Medication error | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Nail avulsion | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Scratch | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Skin abrasion | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Sunburn | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Investigations | ||||||||||||||||
| Transaminases increased | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Back pain | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Musculoskeletal stiffness | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Myalgia | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Pain in extremity | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Plantar fasciitis | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||
| Dizziness | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 1/5 (20%) | 1 |
| Headache | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 2/8 (25%) | 2 | 0/2 (0%) | 0 | 2/8 (25%) | 2 | 0/5 (0%) | 0 |
| Presyncope | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Cough | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 2/8 (25%) | 2 | 0/5 (0%) | 0 |
| Epistaxis | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
| Oropharyngeal pain | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 1/8 (12.5%) | 1 | 0/5 (0%) | 0 |
| Rhinorrhoea | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 2/8 (25%) | 2 | 0/5 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Dermatitis contact | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 1/8 (12.5%) | 1 | 0/5 (0%) | 0 |
| Vascular disorders | ||||||||||||||||
| Flushing | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800 821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT03762681
Other Study ID Numbers:
- NP40520
- 2018-003530-32
First Posted:
Dec 4, 2018
Last Update Posted:
May 11, 2021
Last Verified:
Apr 1, 2021