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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: REGN15160 (SC); Drug: REGN15160 (IV); Drug: Matching Placebo (IV); Drug: Matching Placebo (SC)

• Registration Number: NCT05293678
• Lead Sponsor: Regeneron Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-24
• Study Start: 2022-04-12
• Primary Completion: 2023-01-26
• Study Completion: 2023-01-26
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Key

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

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Higher SC Dose	REGN15160 (SC)	Randomized 3:1
Lower IV Dose	Matching Placebo (IV)	Randomized 3:1
Lower IV Dose	REGN15160 (IV)	Randomized 3:1
Lower SC Dose	REGN15160 (SC)	Randomized 3:1
Mid IV Dose 2	REGN15160 (IV)	Randomized 3:1
Higher IV Dose	REGN15160 (IV)	Randomized 3:1
Mid IV Dose 1	REGN15160 (IV)	Randomized 3:1
Mid SC Dose	Matching Placebo (SC)	Randomized 3:1
Higher SC Dose	Matching Placebo (SC)	Randomized 3:1
Mid IV Dose 1	Matching Placebo (IV)	Randomized 3:1
Mid IV Dose 2	Matching Placebo (IV)	Randomized 3:1
Higher IV Dose	Matching Placebo (IV)	Randomized 3:1
Lower SC Dose	Matching Placebo (SC)	Randomized 3:1
Mid SC Dose	REGN15160 (SC)	Randomized 3:1

Primary Outcome Measures

Name	Time	Method
Occurrence and severity of all serious adverse events (SAEs)	Through Day 169
Occurrence and severity of all treatment emergent adverse events (TEAEs)	Through Day 169

Secondary Outcome Measures

Name	Time	Method
Incidence and titer of anti-drug antibodies (ADA) to REGN15160	Through Day 169
Concentrations of REGN15160 in serum	Through Day 169

Trial Locations

Locations (1)

Regeneron Study Site; 🇧🇪 Leuven, Belgium