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

NCT07526116 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: R22044-HV-25332025-523562-24-00
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Occurrence of Treatment-Emergent Adverse Events (TEAEs)

  Up to 18 weeks

• Severity of TEAEs

  Up to 18 weeks

Secondary Outcomes (1)

• Concentration of REGN22044 in serum

  Up to 18 weeks

Study Arms (2)

Intravenous (IV) Cohorts

EXPERIMENTAL

Drug: REGN22044; Drug: Placebo

Subcutaneous (SC) Cohorts

EXPERIMENTAL

Drug: REGN22044; Drug: Placebo

Interventions

REGN22044 DRUG

Administered per the protocol

Intravenous (IV) Cohorts; Subcutaneous (SC) Cohorts

Placebo DRUG

Administered per the protocol

Intravenous (IV) Cohorts; Subcutaneous (SC) Cohorts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Is judged by the investigator to be in good health as described in the protocol

You may not qualify if:

• History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator
• 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
• 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
• Evidence of active or latent tuberculosis (TB) as documented by medical history and examination

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): May 27, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf