First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00927927
Collaborator
(none)
65
1
15
30
2.2
Study Details
Study Description
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
65 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis
Study Start Date
:
Jun 1, 2009
Actual Primary Completion Date
:
Dec 1, 2011
Actual Study Completion Date
:
Dec 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SD 0.0002 mg/kg Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg |
Drug: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
|
| Experimental: SD 0.0012 mg/kg Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg |
Drug: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
|
| Experimental: SD 0.007 mg/kg Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg |
Drug: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
|
| Experimental: SD 0.035 mg/kg Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg |
Drug: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
|
| Experimental: SD 0.175 mg/kg Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg |
Drug: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
|
| Experimental: SD 0.7 mg/kg Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg |
Drug: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
|
| Experimental: SD 2.5 mg/kg Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg |
Drug: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
|
| Experimental: SD 7.5 mg/kg Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg |
Drug: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
|
| Experimental: SD Placebo Subjects were injected once with placebo |
Drug: placebo
Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
|
| Experimental: MD 0.02 mg/kg Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg |
Drug: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
| Experimental: MD 0.3 mg/kg Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg |
Drug: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
| Experimental: MD 1.0 mg/kg Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg |
Drug: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
| Experimental: MD 1.6 mg/kg Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg |
Drug: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
| Experimental: MD 4.0 mg/kg Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg |
Drug: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
|
| Experimental: MD Placebo Subjects were injected biweekly four times with placebo |
Drug: placebo
Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
|
Outcome Measures
Primary Outcome Measures
- Frequency of Adverse Events [Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.]
Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.
Secondary Outcome Measures
- Area Under the Concentration-time Curve (AUC) [Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.]
Systemic exposure to NNC0142-0002.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
-
Aged between 18 and 75 years (both inclusive)
-
Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
-
Use of highly effective contraception during the trial (both males and females)
Exclusion Criteria:
-
A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
-
An active or latent tuberculosis
-
Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
-
A known significant cardio-vascular disease
-
Vaccination against live virus or bacteria within 4 weeks prior to randomization
-
The use of concomitant medications that are prohibited in the trial (e.g., certain
DMARDs (antirheumatic therapies that are disease modifying), biologics (here:
biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
-
A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
-
Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Berlin | Germany | 10117 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Britta Væver Bysted, DVM, PhD, Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00927927
Other Study ID Numbers:
- NN8555-3618
- 2008-008703-18
First Posted:
Jun 25, 2009
Last Update Posted:
Oct 3, 2016
Last Verified:
Aug 1, 2016
Study Results
Participant Flow
| Recruitment Details | The trial was conducted at one site in Germany. |
|---|---|
| Pre-assignment Detail | A total of 65 subjects were randomised, but only 64 subjects were exposed to trial product. One subject withdrew consent after being randomised but before receiving any trial product. |
| Arm/Group Title | SD 0.0002 mg/kg | SD 0.0012 mg/kg | SD 0.007 mg/kg | SD 0.035 mg/kg | SD 0.175 mg/kg | SD 0.7 mg/kg | SD 2.5 mg/kg | SD 7.5 mg/kg | SD Placebo | MD 0.02 mg/kg | MD 0.3 mg/kg | MD 1.0 mg/kg | MD 1.6 mg/kg | MD 4.0 mg/kg | MD Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg | Subjects were dosed once with placebo | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg | Subjects were injected biweekly four times with placebo |
| Period Title: Overall Study | |||||||||||||||
| STARTED | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 8 | 3 | 5 | 6 | 5 | 5 | 9 |
| Exposed | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 8 | 3 | 5 | 5 | 5 | 5 | 9 |
| COMPLETED | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 1 | 8 | 3 | 5 | 4 | 5 | 5 | 9 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | SD 0.0002 mg/kg | SD 0.0012 mg/kg | SD 0.007 mg/kg | SD 0.035 mg/kg | SD 0.175 mg/kg | SD 0.7 mg/kg | SD 2.5 mg/kg | SD 7.5 mg/kg | SD Placebo | MD 0.02 mg/kg | MD 0.3 mg/kg | MD 1.0 mg/kg | MD 1.6 mg/kg | MD 4.0 mg/kg | MD Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg | Subjects were dosed once with placebo | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg | Subjects were injected biweekly four times with placebo | Total of all reporting groups |
| Overall Participants | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 8 | 3 | 5 | 5 | 5 | 5 | 9 | 64 |
| Age (participants) [Mean (Standard Deviation) ] | ||||||||||||||||
| Mean (Standard Deviation) [participants] |
63.0
(7.9)
2100%
|
60.7
(8.1)
2023.3%
|
66.7
(8.1)
2223.3%
|
58.3
(5.1)
1943.3%
|
58.7
(3.1)
1956.7%
|
52.7
(11.0)
1756.7%
|
49.0
(10.8)
1633.3%
|
69.0
(4.6)
2300%
|
52.8
(7.8)
660%
|
55.3
(5.0)
1843.3%
|
56.4
(9.4)
1128%
|
58.4
(5.5)
1168%
|
53.0
(17.9)
1060%
|
48.2
(7.7)
964%
|
53.7
(11.0)
596.7%
|
56.0
(9.8)
87.5%
|
| Sex: Female, Male (Count of Participants) | ||||||||||||||||
| Female |
3
100%
|
2
66.7%
|
3
100%
|
3
100%
|
2
66.7%
|
2
66.7%
|
3
100%
|
1
33.3%
|
6
75%
|
2
66.7%
|
5
100%
|
3
60%
|
4
80%
|
2
40%
|
8
88.9%
|
49
76.6%
|
| Male |
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
1
33.3%
|
1
33.3%
|
0
0%
|
2
66.7%
|
2
25%
|
1
33.3%
|
0
0%
|
2
40%
|
1
20%
|
3
60%
|
1
11.1%
|
15
23.4%
|
Outcome Measures
| Title | Frequency of Adverse Events |
|---|---|
| Description | Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention. |
| Time Frame | Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo. |
| Arm/Group Title | SD 0.0002 mg/kg | SD 0.0012 mg/kg | SD 0.007 mg/kg | SD 0.035 mg/kg | SD 0.175 mg/kg | SD 0.7 mg/kg | SD 2.5 mg/kg | SD 7.5 mg/kg | SD Placebo | MD 0.02 mg/kg | MD 0.3 mg/kg | MD 1.0 mg/kg | MD 1.6 mg/kg | MD 4.0 mg/kg | MD Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg | Subjects were dosed once with placebo | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg | Subjects were injected biweekly four times with placebo |
| Measure Participants | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 8 | 3 | 5 | 5 | 5 | 5 | 9 |
| Adverse events |
5
|
4
|
3
|
4
|
1
|
8
|
6
|
3
|
9
|
4
|
8
|
13
|
10
|
14
|
9
|
| Serious AE |
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
| Title | Area Under the Concentration-time Curve (AUC) |
|---|---|
| Description | Systemic exposure to NNC0142-0002. |
| Time Frame | Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo. Serum drug concentrations after dosing with less than 0.175 mg/kg (SD cohorts) and 0.3 mg/kg (MD cohorts) were below the lower limit of quantification. |
| Arm/Group Title | SD 0.0002 mg/kg | SD 0.0012 mg/kg | SD 0.007 mg/kg | SD 0.035 mg/kg | SD 0.175 mg/kg | SD 0.7 mg/kg | SD 2.5 mg/kg | SD 7.5 mg/kg | SD Placebo | MD 0.02 mg/kg | MD 0.3 mg/kg | MD 1.0 mg/kg | MD 1.6 mg/kg | MD 4.0 mg/kg | MD Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg | Subjects were dosed once with placebo | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg | Subjects were injected biweekly four times with placebo |
| Measure Participants | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 8 | 3 | 5 | 5 | 5 | 5 | 9 |
| Geometric Mean (Geometric Coefficient of Variation) [microgram×h/mL] |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
91
(306.6)
|
4229
(12.7)
|
16616
(35.2)
|
87461
(29.9)
|
NA
(NA)
|
NA
(NA)
|
4034
(62.8)
|
21883
(29.6)
|
30212
(25.4)
|
83307
(38.3)
|
NA
(NA)
|
Adverse Events
| Time Frame | Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity. | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The safety analysis set included all randomised subjects exposed to at least one dose of NNC0142-0002 or placebo. | |||||||||||||||||||||||||||||
| Arm/Group Title | SD 0.0002 mg/kg | MD 0.02 mg/kg | SD 0.0012 mg/kg | SD 0.007 mg/kg | SD 0.035 mg/kg | SD 0.175 mg/kg | SD 0.7 mg/kg | SD 2.5 mg/kg | SD 7.5 mg/kg | SD Placebo | MD 0.3 mg/kg | MD 1.0 mg/kg | MD 1.6 mg/kg | MD 4.0 mg/kg | MD Placebo | |||||||||||||||
| Arm/Group Description | Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg | Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg | Subjects were dosed once with placebo | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg | Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg | Subjects were injected biweekly four times with placebo | |||||||||||||||
All Cause Mortality |
||||||||||||||||||||||||||||||
| SD 0.0002 mg/kg | MD 0.02 mg/kg | SD 0.0012 mg/kg | SD 0.007 mg/kg | SD 0.035 mg/kg | SD 0.175 mg/kg | SD 0.7 mg/kg | SD 2.5 mg/kg | SD 7.5 mg/kg | SD Placebo | MD 0.3 mg/kg | MD 1.0 mg/kg | MD 1.6 mg/kg | MD 4.0 mg/kg | MD Placebo | ||||||||||||||||
| 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 | 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 | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||||||||
| SD 0.0002 mg/kg | MD 0.02 mg/kg | SD 0.0012 mg/kg | SD 0.007 mg/kg | SD 0.035 mg/kg | SD 0.175 mg/kg | SD 0.7 mg/kg | SD 2.5 mg/kg | SD 7.5 mg/kg | SD Placebo | MD 0.3 mg/kg | MD 1.0 mg/kg | MD 1.6 mg/kg | MD 4.0 mg/kg | MD Placebo | ||||||||||||||||
| 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 | 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 | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) | 0/8 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/9 (0%) | |||||||||||||||
| General disorders | ||||||||||||||||||||||||||||||
| Fatigue | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||||
| Femoral neck fracture | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||||||||
| SD 0.0002 mg/kg | MD 0.02 mg/kg | SD 0.0012 mg/kg | SD 0.007 mg/kg | SD 0.035 mg/kg | SD 0.175 mg/kg | SD 0.7 mg/kg | SD 2.5 mg/kg | SD 7.5 mg/kg | SD Placebo | MD 0.3 mg/kg | MD 1.0 mg/kg | MD 1.6 mg/kg | MD 4.0 mg/kg | MD Placebo | ||||||||||||||||
| 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 | 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 | 2/3 (66.7%) | 1/3 (33.3%) | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) | 1/3 (33.3%) | 3/3 (100%) | 3/3 (100%) | 1/3 (33.3%) | 6/8 (75%) | 4/5 (80%) | 4/5 (80%) | 5/5 (100%) | 3/5 (60%) | 8/9 (88.9%) | |||||||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||||||||||||
| Vertigo | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/9 (11.1%) | 1 |
| Eye disorders | ||||||||||||||||||||||||||||||
| Lacrimation increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||||||||||||||||||
| Abdominal pain upper | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Diarrhoea | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/9 (0%) | 0 |
| Flatulence | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Nausea | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/9 (11.1%) | 1 |
| Stomatitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Vomiting | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 1/9 (11.1%) | 1 |
| General disorders | ||||||||||||||||||||||||||||||
| Fatigue | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Injection site pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Oedema peripheral | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/9 (11.1%) | 1 |
| Hepatobiliary disorders | ||||||||||||||||||||||||||||||
| Cholelithiasis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||||||||||||||
| Bronchitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/5 (20%) | 1 | 2/5 (40%) | 2 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Diverticulitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Gastroenteritis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Nasopharyngitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 2 | 3/3 (100%) | 3 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/8 (25%) | 2 | 3/5 (60%) | 3 | 4/5 (80%) | 5 | 3/5 (60%) | 4 | 2/5 (40%) | 3 | 1/9 (11.1%) | 1 |
| Oral herpes | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Paronychia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||||
| Incorrect dose administered | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Injury | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Investigations | ||||||||||||||||||||||||||||||
| Alanine aminotransferase increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Blood creatine phosphokinase increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/9 (11.1%) | 1 |
| Epstein-Barr virus antibody positive | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||||||
| Arthralgia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Back pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Musculoskeletal pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Rheumatoid arthritis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||||||||||||||
| Dizziness | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Headache | 2/3 (66.7%) | 4 | 1/3 (33.3%) | 2 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 1/5 (20%) | 1 | 3/5 (60%) | 4 | 1/9 (11.1%) | 1 |
| Migraine | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/9 (0%) | 0 |
| Sciatica | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/9 (11.1%) | 1 |
| Psychiatric disorders | ||||||||||||||||||||||||||||||
| Depression | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||||
| Cough | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||||
| Rash | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 3 | 0/9 (0%) | 0 |
| Skin irritation | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/9 (11.1%) | 1 |
| Vascular disorders | ||||||||||||||||||||||||||||||
| Haematoma | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/9 (0%) | 0 |
| Hypertension | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/9 (0%) | 0 |
Limitations/Caveats
Maximum tolerated dose was not reached.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Novo Nordisk reserves the right to defer data release until specified milestones, e.g. availability of a clinical trial report. Novo Nordisk reserves the right to postpone publication and/or communication for short period to protect intellectual property. Novo Nordisk reserves the right to prior review of site-specific publications and to ask for deferment of publication of individual site results until after the primary manuscript is accepted for publication.
Results Point of Contact
| Name/Title | Public Access to Clinical Trials |
|---|---|
| Organization | Novo Nordisk A/S |
| Phone | |
| RA-RNDUS-ClinTriDisc@ITS.JNJ.com |
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00927927
Other Study ID Numbers:
- NN8555-3618
- 2008-008703-18
First Posted:
Jun 25, 2009
Last Update Posted:
Oct 3, 2016
Last Verified:
Aug 1, 2016