Phase
Condition
N/ATreatment
Matching Placebo (SC)
Matching Placebo (IV)
REGN7508 (IV)
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit
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
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
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
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:
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
Whole blood donation within the previous 56 days or plasma donation within theprevious 7 days prior to the screening visit
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
Estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 at screening
Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit
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
History of alcohol abuse within the last 2 years prior to the day 1 visit
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
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
Connect with a study center
Labcorp Clinical Research Unit
Leeds, LS2 9LH
United KingdomSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.