A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adults
NCT07526116 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2026-04-13
Summary
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)
Conditions
- Healthy Volunteer
Interventions
- DRUG
-
REGN22044
Administered per the protocol
- DRUG
-
Administered per the protocol
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-05-07
- Primary Completion
- 2027-05-27
- Completion
- 2027-05-27
- FDA Drug
- Yes
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