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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: REGN17092; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05923424

2023- 505041-52-00 (Registry Identifier)

R17092-HV-2312

Details and patient eligibility

About

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)

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 10 patient groups

Cohort 1 Mid IV Dose

Experimental group

Description:

Randomized 6:2 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN17092

Cohort 3 High IV Dose

Experimental group

Description:

Randomized 6:2 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN17092

Cohort 5 Higher IV Dose

Experimental group

Description:

Randomized 6:2 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN17092

Cohort 6 Low IV Dose

Experimental group

Description:

Randomized 6:2 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN17092

Cohort 2 Mid SC Dose

Experimental group

Description:

Randomized 6:2 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN17092

Cohort 4 High SC Dose

Experimental group

Description:

Randomized 6:2 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN17092

Cohort 7 Low SC Dose

Experimental group

Description:

Randomized 6:2 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN17092

Expansion Cohort 1

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN17092

Expansion Cohort 2

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN17092

Expansion Cohort 3

Experimental group

Description:

Randomized 3:1 for single ascending dose

Treatment:

Drug: Matching Placebo

Drug: REGN17092