RECRUITING Phase 1 ClinicalTrials.gov

A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adults

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07526116

Registry updated: 2026-08-25

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Description

This clinical study will evaluate the study drug, REGN22044, in healthy participants. REGN22044 has not previously been studied in humans. The purpose of this study is to learn: * What side effects may happen when REGN22044 is taken * How much of REGN22044 is in the blood at different times * Whether the body makes antibodies against REGN22044 (which could make the drug less effective or could lead to side effects)

Interventions

REGN22044 (Drug)
Administered per the protocol
Placebo (Drug)
Administered per the protocol

Eligibility criteria

Key Inclusion Criteria: 1\. Is judged by the investigator to be in good health as described in the protocol Key Exclusion Criteria: 1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator 2. Use of any prescription or non-prescription medications or nutritional supplements from approximately 14 days or 5 half-lives, whichever is longer, prior to administration of study intervention or any planned use through the end of the study, except the permitted medications as listed in the protocol 3. Participants with fever (\>38°C) associated with infection, or chronic, persistent, or recurring infection(s) requiring active treatment with antibiotics, antivirals or antifungals within 8 weeks prior to the screening visit or the randomization visit, or other frequent recurrent infections deemed unacceptable as per investigator judgment 4. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination Note: Other protocol defined Inclusion/ Exclusion criteria apply.

Conditions

Healthy Volunteer

Locations

Ghent University Hospital — Ghent, Oost-Vlaanderen, Belgium

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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