A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants

Last updated: September 27, 2024
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Matching Placebo (SC)

Matching Placebo (IV)

REGN7508 (IV)

Clinical Study ID

NCT05603195
R7508-HV-21102
2022-002001-20
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants.

This study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug

  • How much study drug is in the blood at different times

  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit

  2. Judged by the investigator to be in good health based on medical history, physicalexamination, vital sign measurements, and echocardiograms (ECGs) performed atscreening and/or prior to administration of initial dose of study drug

  3. Participant is in good health based on laboratory safety testing obtained at thescreening visit and/or prior to administration of initial dose of study drug

  4. Normal activated partial thromboplastin time (aPTT), normal prothrombin time (PT),and normal platelet counts at screening period and at the day -1 visit as defined bythe local laboratory

  5. Hemoglobin value ≥11.0 g/dL for females and ≥12.9 g/dL for males at the screeningand day 1 visits

Exclusion

Key Exclusion Criteria:

  1. History of any major surgical procedure or clinically significant physical trauma,in the opinion of the investigator, that may pose a risk to the participant by studyparticipation

  2. Whole blood donation within the previous 56 days or plasma donation within theprevious 7 days prior to the screening visit

  3. History of clinically significant cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrine, hematological, psychiatric, neurological, ordermatologic disease, as assessed by the investigator, that may confound the resultsof the study or poses an additional risk to the participant by study participation,as defined in the protocol

  4. Estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 at screening

  5. Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit

  6. Confirmed positive drug test result at the screening visit and/or prior torandomization or a history of drug abuse within a year prior to the screening visit

  7. History of alcohol abuse within the last 2 years prior to the day 1 visit

  8. Any malignancy, except for nonmelanoma skin cancer or cervical/anus in situ, thathave been resected with no evidence of metastatic disease for 3 years prior to thescreening visit

  9. History of significant multiple and/or severe allergies (eg, latex gloves) or hashad an anaphylactic reaction to prescription or nonprescription drugs or food

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Study Design

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: Matching Placebo (SC)
Phase: 1
Study Start date:
January 12, 2023
Estimated Completion Date:
September 17, 2024

Connect with a study center

  • Labcorp Clinical Research Unit

    Leeds, LS2 9LH
    United Kingdom

    Site Not Available

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