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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2025-03-04

Brief Summary

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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)

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1 Mid IV Dose

Randomized 6:2 for single ascending dose

Group Type EXPERIMENTAL

REGN17092

Intervention Type DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type DRUG

Single ascending IV or SC administration per the protocol

Cohort 3 High IV Dose

Randomized 6:2 for single ascending dose

Group Type EXPERIMENTAL

REGN17092

Intervention Type DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type DRUG

Single ascending IV or SC administration per the protocol

Cohort 5 Higher IV Dose

Randomized 6:2 for single ascending dose

Group Type EXPERIMENTAL

REGN17092

Intervention Type DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type DRUG

Single ascending IV or SC administration per the protocol

Cohort 6 Low IV Dose

Randomized 6:2 for single ascending dose

Group Type EXPERIMENTAL

REGN17092

Intervention Type DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type DRUG

Single ascending IV or SC administration per the protocol

Cohort 2 Mid SC Dose

Randomized 6:2 for single ascending dose

Group Type EXPERIMENTAL

REGN17092

Intervention Type DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type DRUG

Single ascending IV or SC administration per the protocol

Cohort 4 High SC Dose

Randomized 6:2 for single ascending dose

Group Type EXPERIMENTAL

REGN17092

Intervention Type DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type DRUG

Single ascending IV or SC administration per the protocol

Cohort 7 Low SC Dose

Randomized 6:2 for single ascending dose

Group Type EXPERIMENTAL

REGN17092

Intervention Type DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type DRUG

Single ascending IV or SC administration per the protocol

Expansion Cohort 1

Randomized 3:1 for single ascending dose

Group Type EXPERIMENTAL

REGN17092

Intervention Type DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type DRUG

Single ascending IV or SC administration per the protocol

Expansion Cohort 2

Randomized 3:1 for single ascending dose

Group Type EXPERIMENTAL

REGN17092

Intervention Type DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type DRUG

Single ascending IV or SC administration per the protocol

Expansion Cohort 3

Randomized 3:1 for single ascending dose

Group Type EXPERIMENTAL

REGN17092

Intervention Type DRUG

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Matching Placebo

Intervention Type DRUG

Single ascending IV or SC administration per the protocol

Interventions

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REGN17092

Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol

Intervention Type DRUG

Matching Placebo

Single ascending IV or SC administration per the protocol

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes