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

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN22044 in Healthy Adult Participants

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07526116

Enrollment

Registered

2026-04-13

Start date

2026-06-05

Completion date

2027-02-08

Last updated

2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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)

Interventions

DRUGREGN22044

Administered per the protocol

DRUGPlacebo

Administered per the protocol

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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/

Design outcomes

Primary

Measure	Time frame
Occurrence of Treatment-Emergent Adverse Events (TEAEs)	Up to 18 weeks
Severity of TEAEs	Up to 18 weeks

Secondary

Measure	Time frame
Concentration of REGN22044 in serum	Up to 18 weeks

Countries

Belgium

Contacts

CONTACTClinical Trials Administrator

clinicaltrials@regeneron.com844-734-6643

STUDY_DIRECTORClinical Trial Management

Regeneron Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026