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

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05293678
• Other study ID #: R15160-HV-2203
• Secondary ID: 2022-000182-41
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2022
• Est. completion date: January 26, 2023

Study information

• Verified date: February 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 26, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Key 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• REGN15160 (IV)
Administered in single intravenous (IV) dose
• Matching Placebo (IV)
Administered in single IV dose
• REGN15160 (SC)
Administered in single subcutaneous (SC) dose
• Matching Placebo (SC)
Administered in single SC dose

Locations

Country	Name	City	State
Belgium	Regeneron Study Site	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence and severity of all treatment emergent adverse events (TEAEs)		Through Day 169
Primary	Occurrence and severity of all serious adverse events (SAEs)		Through Day 169
Secondary	Concentrations of REGN15160 in serum		Through Day 169
Secondary	Incidence and titer of anti-drug antibodies (ADA) to REGN15160		Through Day 169