A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults

• Sponsor: AstraZeneca (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05184062
• Collaborator: (none)
• Enrollment: 272
• Locations: 14
• Arms: 2
• Anticipated Duration (Months): 19.3
• Patients Per Site: 19.4
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions).

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Disease 2019 (COVID-19)	Drug: 600 mg AZD7442 IV; Drug: 600mg placebo IV	Phase 2

Detailed Description

A Phase II, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD7442 for administration to prevent and treat coronavirus disease 2019 (COVID-19) in Chinese adult participants (including healthy participants as well as participants with stable medical conditions), approximately 479 days in duration for each participant.

Study Design

• Study Type: Interventional
• Actual Enrollment: 272 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A Phase II Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
• Actual Study Start Date: Dec 3, 2021
• Anticipated Primary Completion Date: Aug 13, 2022
• Anticipated Study Completion Date: Jul 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD7442 co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.	Drug: 600 mg AZD7442 IV; Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion.; Other Names: AZD7442
Placebo Comparator: Placebo co-administration of a single dose of 600mg placebo by intravenous (IV) infusion.	Drug: 600mg placebo IV; Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events (AEs) [From day1 to 6 months after administration.]

   To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) ≥ 18 years of age.

2. Incidence of serious adverse events (SAEs) [From day1 to 6 months after administration.]

   To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) ≥ 18 years of age.

3. Incidence of adverse event of special interests (AESIs) [From day1 to 6 months after administration.]

   To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) ≥ 18 years of age.

4. Safety as determined by abnormality in haematology [From day1 to 6 months after administration.]

   Measurement of white blood cell (WBC) count, red blood cell (RBC) count, haemoglobin (Hb), haematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, Platelets, Reticulocytes absolute count.

5. Safety as determined by abnormality in clinical chemistry [From day1 to 6 months after administration.]

   Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), creatinine, albumin, calcium, phosphate, glucose, c-reactive protein (CRP), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), total bilirubin, conjugated bilirubin, creatine kinase.

6. Safety as determined by abnormality in urinalysis [From day1 to 6 months after administration.]

   Measurement of glucose, protein, blood and microscopy.

7. Safety as determined by abnormality in Coagulation. [From day1 to 6 months after administration.]

   Measurement of international normalised ratio (INR), prothrombin time, activated partial thrombin time (aPTT).

8. Incidence of abnormal 12-lead electrocardiogram (ECG) [From day1 to 6 months after administration.]

   Results for PR interval, QRS duration, QT interval, QTcF interval, RR interval, and heart rate will be analyzed.

9. Safety as determined by abnormal vital signs (blood pressure, pulse rate, body temperature, and respiratory rate) [From day1 to 6 months after administration.]

   Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg), pulse rate (beats per minute), body temperature (in degree Celsius), respiratory rate (breaths per minute).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adults ≥ 18 years

2. Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)

3. Healthy or medically stable participants

4. Contraceptive within 365 days post dosing

Exclusion Criteria:

1. Medical condition:

• Known hypersensitivity to monoclonal antibody (mAb) or investigational product (IP) component.

• Acute illness including fever on the day prior to or day of dosing.

• Any other significant disease increase the risk to participant study.

1. Laboratory related:

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 × upper limit of normal (ULN), alkaline phosphatase (ALP) > 1.5 × ULN, or TBL (total bilirubin) > 1.5 × ULN (unless due to Gilbert's syndrome).

• Serum creatinine > 176 μmol/L.

• Haemoglobin < 10g/dL.

• Platelet count < 100 × 10^3/μL.

• White blood cell count < 3.5 × 10^{3/μL or neutrophil count < 1.5 × 10}3/μL.

• Other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results.

1. COVID-19 infection history/any receipt of mAb indicated for COVID-19.

2. Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Baoding		China	071000
2	Research Site	Beijing		China	100034
3	Research Site	Changsha		China	410008
4	Research Site	Chongqing		China	400016
5	Research Site	Fuzhou		China	350005
6	Research Site	Haikou		China	570311
7	Research Site	Hangzhou		China	310006
8	Research Site	Lanzhou		China	730030
9	Research Site	Shanghai		China	200040
10	Research Site	Shanghai		China	200080
11	Research Site	Shanghai		China	200120
12	Research Site	Suzhou		China	215004
13	Research Site	Urumqi		China	830054
14	Research Site	Xuzhou		China	221000

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT05184062
• Other Study ID Numbers: D8850C00008
• First Posted: Jan 11, 2022
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• 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
• Keywords provided by AstraZeneca: Coronavirus; COVID-19; AZD7442
• Additional relevant MeSH terms: COVID-19; Coronavirus Infections

Study Results

No Results Posted as of Jul 14, 2022