Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19

NCT ID: NCT05293678

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2023-01-26

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).

The secondary objectives of the study are:

• To assess the concentration-time profile of REGN15160 in serum
• To assess the immunogenicity of REGN15160

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lower IV Dose

Randomized 3:1

Group Type: EXPERIMENTAL

REGN15160 (IV)

Intervention Type: DRUG

Administered in single intravenous (IV) dose

Matching Placebo (IV)

Intervention Type: DRUG

Administered in single IV dose

Mid IV Dose 1

Randomized 3:1

Group Type: EXPERIMENTAL

REGN15160 (IV)

Intervention Type: DRUG

Administered in single intravenous (IV) dose

Matching Placebo (IV)

Intervention Type: DRUG

Administered in single IV dose

Mid IV Dose 2

Randomized 3:1

Group Type: EXPERIMENTAL

REGN15160 (IV)

Intervention Type: DRUG

Administered in single intravenous (IV) dose

Matching Placebo (IV)

Intervention Type: DRUG

Administered in single IV dose

Higher IV Dose

Randomized 3:1

Group Type: EXPERIMENTAL

REGN15160 (IV)

Intervention Type: DRUG

Administered in single intravenous (IV) dose

Matching Placebo (IV)

Intervention Type: DRUG

Administered in single IV dose

Lower SC Dose

Randomized 3:1

Group Type: EXPERIMENTAL

REGN15160 (SC)

Intervention Type: DRUG

Administered in single subcutaneous (SC) dose

Matching Placebo (SC)

Intervention Type: DRUG

Administered in single SC dose

Mid SC Dose

Randomized 3:1

Group Type: EXPERIMENTAL

REGN15160 (SC)

Intervention Type: DRUG

Administered in single subcutaneous (SC) dose

Matching Placebo (SC)

Intervention Type: DRUG

Administered in single SC dose

Higher SC Dose

Randomized 3:1

Group Type: EXPERIMENTAL

REGN15160 (SC)

Intervention Type: DRUG

Administered in single subcutaneous (SC) dose

Matching Placebo (SC)

Intervention Type: DRUG

Administered in single SC dose

Interventions

REGN15160 (IV)

Administered in single intravenous (IV) dose

Intervention Type: DRUG

Matching Placebo (IV)

Administered in single IV dose

Intervention Type: DRUG

REGN15160 (SC)

Administered in single subcutaneous (SC) dose

Intervention Type: DRUG

Matching Placebo (SC)

Administered in single SC dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization using a local reverse transcription polymerase chain reaction (RT-PCR) test or other molecular diagnostic assay and sample collection following assay standards

2. Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening

3. Has a body mass index (BMI) between 18 and 31 kg/m2 (inclusive) at the screening visit

4. Is judged by the investigator to be in good health based on medical history, as defined in the protocol

5. Is in good health based on laboratory safety testing obtained at the screening visit

Exclusion Criteria

1. History of clinically significant disease and any concern, as defined in the protocol and as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation

2. Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit

3. Has history of alcohol or drug abuse as determined by the investigator

4. Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food

5. Use of any prescription and non-prescription medications or nutritional supplements within approximately 5 half-lives or 2 weeks, whichever is longer, prior to first administration of the study drug through the end of the study, except for the permitted medications listed

6. Participated in any clinical research study evaluating another investigational drug including biologics or therapy, including specific immunotherapy, within at least 5 half-lives or 90 days (whichever is longer) of an investigational biologic drug, or at least 4 weeks for small molecules or other investigational drugs, prior to the screening visit

7. Is a pregnant or breastfeeding woman

8. Is a woman of childbearing potential (WOCBP)1 who is unwilling to practice highly effective contraception (as defined in the protocol) prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after study drug administration

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Study Site

Leuven, , Belgium

Countries

Belgium

Other Identifiers

2022-000182-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R15160-HV-2203

Identifier Type: -

Identifier Source: org_study_id