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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRegeneron Pharmaceuticals

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • REGN22044

    Drug

    Administered per the protocol

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Intravenous (IV) CohortsExperimental treatment 2 interventions
Group B: Subcutaneous (SC) CohortsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to 18 weeks
2

Severity of TEAEs

Time frame
Up to 18 weeks

Secondary outcomes

1

Concentration of REGN22044 in serum

Time frame
Up to 18 weeks

Other outcomes

Sponsors and contacts

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