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

Covid19 Clinical Trial

— COSMIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280717
• Other study ID #: VIR-7831-5012
• Secondary ID: GSK Study 218128
• Status: Recruiting
• Phase: Phase 1
• Start date: March 28, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: November 2022
• Source: Vir Biotechnology, Inc.
• Contact: Study Inquiry
• Phone: 4156545281
• Email: clinicaltrials[@]vir.bio
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 504
• Est. completion date: May 30, 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

• For Part C, inclusion in the Japanese subgroup analysis, a participant must meet all of the following criteria: Japanese ancestry, defined as being a descendant of 4 ethnic Japanese grandparents and 2 ethnic Japanese parents.

• 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.

• Known hypersensitivity to any constituent present in the investigational product or history of severe hypersensitivity or anaphylaxis after receiving a COVID-19 vaccine

• Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity 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.

• For Part A and Part B, 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• sotrovimab
via IM injection
• sotrovimab
via IM injection
• sotrovimab
via IM injection
• sotrovimab
via IM injection
• sotrovimab
via IM injection
• sotrovimab
via IM injection
• sotrovimab
via IV infusion

Locations

Country	Name	City	State
United States	Investigative Site	Atlantis	Florida
United States	Investigative Site	Austin	Texas
United States	Investigative Site	Binghamton	New York
United States	Investigative Site	Edgewater	Florida
United States	Investigative Site	Houston	Texas
United States	Investigative Site	Medford	Oregon
United States	Investigative Site	Riverside	California
United States	Investigative Site	Saint Louis	Missouri
United States	Investigative Site	West Jordan	Utah
United States	Investigative Site	Yukon	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Vir Biotechnology, Inc.	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29		Up to Day 29
Primary	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
Primary	Part C (Cohort 7, 8): Number of participants with AEs, SAEs, and AESI		Up to Day 29
Secondary	Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab		Up to Day 29
Secondary	Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29		Up to Day 29
Secondary	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
Secondary	Part A: Serum concentration following administration of sotrovimab through Day 29		Up to Day 29
Secondary	Part A: Serum concentration following administration of sotrovimab through Week 24		Up to Week 24
Secondary	Part A (Cohort 3, 4) and Part B: Number of participants with AEs, SAEs, and AESI		Up to Day 29
Secondary	Part A and Part B: Number of participants with AEs, SAEs, and AESI		Up to Week 35
Secondary	Part B: AUC(D1-29) following administration of sotrovimab		Up to Day 29
Secondary	Part B: Cmax following administration of sotrovimab through Day 29		Up to Day 29
Secondary	Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24		Up to Week 24
Secondary	Part B: Serum concentration following administration of sotrovimab through Day 29		Up to Day 29
Secondary	Part B: Serum concentration following administration of sotrovimab through Week 24		Up to Week 24
Secondary	Part C: AUC(D1-29) following administration of sotrovimab		Up to Day 29
Secondary	Part C: Cmax following administration of sotrovimab through Day 29		Up to Day 29
Secondary	Part C: Serum concentration following administration of sotrovimab through Day 29		Up to Day 29
Secondary	Part C: Serum concentration following administration of sotrovimab through Week 24		Up to Week 24
Secondary	Part C: Number of participants with AEs, SAEs, and AESI		Up to Week 35