Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)

Sponsor

Vir Biotechnology, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05280717

Collaborator

GlaxoSmithKline (Industry)

254

Enrollment

Locations

Arms

11.6

Anticipated Duration (Months)

25.4

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered via intramuscular (IM) route in male or female healthy participants aged 18 to 65 years. The study will be conducted in two parts (Part A and an optional Part B).

Condition or Disease	Intervention/Treatment	Phase
Covid19	Biological: sotrovimab Biological: sotrovimab Biological: sotrovimab Biological: sotrovimab Biological: sotrovimab Biological: sotrovimab	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

254 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Phase 1, Open-label, Randomized, Parallel Group, Single-dose Clinical Pharmacology Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Different Concentrations of Sotrovimab Administered at Different Injection Sites, in Male or Female Healthy Participants Aged 18 to 65 Years

Actual Study Start Date :

Mar 28, 2022

Anticipated Primary Completion Date :

Jul 7, 2022

Anticipated Study Completion Date :

Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A Cohort 1: Concentration 1 of sotrovimab administered at injection site 1	Biological: sotrovimab via IM injection
Experimental: Part A Cohort 2: Concentration 2 of sotrovimab administered at injection site 1	Biological: sotrovimab via IM injection
Experimental: Part A Cohort 3: Concentration 2 of sotrovimab administered at injection site 2	Biological: sotrovimab via IM injection
Experimental: Part A Cohort 4: Concentration 2 of sotrovimab administered at injection site 3	Biological: sotrovimab via IM injection
Experimental: Part B Cohort 5: Concentration 1 of sotrovimab administered at potential injection site 1,2,3 or other	Biological: sotrovimab via IM injection
Experimental: Part B Cohort 6: Concentration 2 of sotrovimab administered at potential injection site 1,2,3 or other	Biological: sotrovimab via IM injection

Outcome Measures

Primary Outcome Measures

Part A (Cohort 1, 2): Area under the serum concentration-time curve (AUC) from Day 1 to Day 29 (AUC D1-29) following administration of sotrovimab [Up to Day 29]
Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29 [Up to Day 29]
Part A (Cohort 1, 2): Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESI) through Day 29 [Up to Day 29]

Secondary Outcome Measures

Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab [Up to Day 29]
Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29 [Up to Day 29]
Part A (Cohort 1, 2, 3, 4): Area under the serum concentration-time curve from time zero to infinity (AUCinf) following administration of sotrovimab at injection sites 1, 2 and 3 through Week 24 [Up to Week 24]
Part A: Serum concentration following administration of sotrovimab through Day 29 [Up to Day 29]
Part A: Serum concentration following administration of sotrovimab through Week 24 [Up to Week 24]
Part A and Part B: Number of participants with AEs, SAEs, and AESI [Up to Week 35]
Part B: AUC(D1-29) following administration of sotrovimab [Up to Day 29]
Part B: Cmax following administration of sotrovimab through Day 29 [Up to Day 29]
Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24 [Up to Week 24]
Part B: Serum concentration following administration of sotrovimab through Day 29 [Up to Day 29]
Part B: Serum concentration following administration of sotrovimab through Week 24 [Up to Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female participants, aged 18 to 65 years, inclusive.
Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Body Mass Index (BMI) within the range of 18 to 30 kilogram per square meter (kg/m^2).
Capable of giving signed informed consent

Exclusion Criteria:

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Breast cancer within the past 10 years
Abnormal blood pressure at Screening.
Significant allergies to humanized monoclonal antibody.
Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity sensitivity reactions
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Use of any over-the-counter or prescription medications unless permitted by the protocol or approved by the Investigator in conjunction with the GSK medical monitor.
Any condition that would prohibit receipt of injections in the investigator's opinion, such as coagulation disorder, bleeding diathesis, or thrombocytopenia.
Treatment with biologic agents (such as) within 3 months or 5 half-lives
Receipt of convalescent plasma from a recovered COVID-19 participant or anti- severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) monoclonal antibody (mAb) within the last 3 months.
Receipt of any vaccine within 48 hours prior to enrollment.
Has received a SARS-CoV-2 vaccine but has not completed all doses in the series more than 28 days prior to Screening.
Exposure to more than 4 new chemical entities (e.g., investigational pharmaceuticals) within 12 months prior to the first dosing day.
Enrolment in any investigational vaccine study within the last 180 days or enrollment in any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives
Current enrolment or past participation in this clinical study.
A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody test result at Screening or within 3 months prior to dosing.
Positive pre-study drug/alcohol screen.
Positive human immunodeficiency virus (HIV) antibody test.
History of regular alcohol consumption within 6 months prior to the study.
Regular use of known drugs of abuse.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site	Riverside	California	United States	92503
2	Investigative Site	Atlantis	Florida	United States	33462
3	Investigative Site	Edgewater	Florida	United States	32132
4	Investigative Site	Saint Louis	Missouri	United States	63141
5	Investigative Site	Binghamton	New York	United States	13901
6	Investigative Site	Yukon	Oklahoma	United States	73099
7	Investigative Site	Medford	Oregon	United States	97504
8	Investigative Site	Austin	Texas	United States	78745
9	Investigative Site	Houston	Texas	United States	77065
10	Investigative Site	West Jordan	Utah	United States	84088