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

November 2, 2022 updated by: Vir Biotechnology, Inc.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
504

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Riverside, California, United States, 92503
        • Recruiting
        • Investigative Site
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • Investigative Site
      • Edgewater, Florida, United States, 32132
        • Recruiting
        • Investigative Site
        • Contact:
          • Study Inquiry
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Investigative Site
    • New York
      • Binghamton, New York, United States, 13901
        • Recruiting
        • Investigative Site
    • Oklahoma
      • Yukon, Oklahoma, United States, 73099
        • Recruiting
        • Investigative Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Investigative Site
        • Contact:
          • Study Inquiry
    • Texas
      • Austin, Texas, United States, 78745
        • Recruiting
        • Investigative Site
      • Houston, Texas, United States, 77065
        • Recruiting
        • Investigative Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A Cohort 1: Concentration 1 of sotrovimab
administered at injection site 1
Biological: sotrovimab
via IM injection
Biological: sotrovimab
via IV infusion
Experimental: Part A Cohort 2: Concentration 2 of sotrovimab
administered at injection site 1
Biological: sotrovimab
via IM injection
Biological: sotrovimab
via IV infusion
Experimental: Part A Cohort 3: Concentration 2 of sotrovimab
administered at injection site 2
Biological: sotrovimab
via IM injection
Biological: sotrovimab
via IV infusion
Experimental: Part A Cohort 4: Concentration 2 of sotrovimab
administered at injection site 3
Biological: sotrovimab
via IM injection
Biological: sotrovimab
via IV infusion
Experimental: Part B Cohort 5: Concentration 1 of sotrovimab
administered at potential injection site 1,2,3 or other
Biological: sotrovimab
via IM injection
Biological: sotrovimab
via IV infusion
Experimental: Part B Cohort 6: Concentration 2 of sotrovimab
administered at potential injection site 1,2,3 or other
Biological: sotrovimab
via IM injection
Biological: sotrovimab
via IV infusion
Experimental: Part C Cohort 7: Concentration 2 of sotrovimab
administered by intravenous (IV) infusion
Biological: sotrovimab
via IM injection
Biological: sotrovimab
via IV infusion
Experimental: Part C Cohort 8: Concentration 2 of sotrovimab
administered by IV infusion
Biological: sotrovimab
via IM injection
Biological: sotrovimab
via IV infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: Up to Day 29
Up to Day 29
Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29
Time Frame: Up to 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
Time Frame: Up to Day 29
Up to Day 29
Part C (Cohort 7, 8): Number of participants with AEs, SAEs, and AESI
Time Frame: Up to Day 29
Up to Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab
Time Frame: Up to Day 29
Up to Day 29
Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29
Time Frame: Up to 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
Time Frame: Up to Week 24
Up to Week 24
Part A: Serum concentration following administration of sotrovimab through Day 29
Time Frame: Up to Day 29
Up to Day 29
Part A: Serum concentration following administration of sotrovimab through Week 24
Time Frame: Up to Week 24
Up to Week 24
Part A (Cohort 3, 4) and Part B: Number of participants with AEs, SAEs, and AESI
Time Frame: Up to Day 29
Up to Day 29
Part A and Part B: Number of participants with AEs, SAEs, and AESI
Time Frame: Up to Week 35
Up to Week 35
Part B: AUC(D1-29) following administration of sotrovimab
Time Frame: Up to Day 29
Up to Day 29
Part B: Cmax following administration of sotrovimab through Day 29
Time Frame: Up to Day 29
Up to Day 29
Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24
Time Frame: Up to Week 24
Up to Week 24
Part B: Serum concentration following administration of sotrovimab through Day 29
Time Frame: Up to Day 29
Up to Day 29
Part B: Serum concentration following administration of sotrovimab through Week 24
Time Frame: Up to Week 24
Up to Week 24
Part C: AUC(D1-29) following administration of sotrovimab
Time Frame: Up to Day 29
Up to Day 29
Part C: Cmax following administration of sotrovimab through Day 29
Time Frame: Up to Day 29
Up to Day 29
Part C: Serum concentration following administration of sotrovimab through Day 29
Time Frame: Up to Day 29
Up to Day 29
Part C: Serum concentration following administration of sotrovimab through Week 24
Time Frame: Up to Week 24
Up to Week 24
Part C: Number of participants with AEs, SAEs, and AESI
Time Frame: Up to Week 35
Up to Week 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vir Biotechnology, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 4, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VIR-7831-5012
  • GSK Study 218128 (Other Identifier: GlaxoSmithKline)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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