A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN17092, an Anti-SARS-CoV-2 (COVID-19) Monoclonal Antibody, in Adult Healthy Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05923424
• Other study ID #: R17092-HV-2312
• Secondary ID: 2023- 505041-52-
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 28, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. This is the first time that REGN17092 will be given to people.

Other aims are to assess:

• How much of the study drug is in the blood at different times

• Whether the body makes its own antibodies against the study drug (which could make the drug less effective or lead to side effects)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• 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 as described in the protocol

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/m^2 (inclusive) at the screening visit

4. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram (ECG)s performed at screening and/or prior to administration of initial dose of study drug

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol

2. Presents any concern to the investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study

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

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

5. 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

NOTE: Other protocol defined inclusion / exclusion criteria apply

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN17092
Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
• Matching Placebo
Single ascending IV or SC administration per the protocol

Locations

Country	Name	City	State
Belgium	UZ Leuven Gasthuisberg Campus	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 of all treatment emergent adverse events (TEAEs)		Through approximately day 365
Primary	Severity of all TEAEs		Through approximately day 365
Primary	Occurrence of all treatment emergent serious adverse events (TE-SAEs)		Through approximately day 365
Primary	Severity of all TE-SAEs		Through approximately day 365
Secondary	Concentrations of REGN17092 in serum over time		Through approximately day 365
Secondary	Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time		Through approximately day 365
Secondary	Titer of ADAs to REGN17092 over time		Through approximately day 365