Status:
COMPLETED
A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The study is researching an experimental drug called REGN7544.The study is focused on healthy adults. The aim of the study is to see how safe and tolerable the study drug is in healthy adults. The st...
Eligibility Criteria
Inclusion
- Key
- Has a body mass index between 18 and 32 kg/m\^2
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug, as defined in the protocol
- Has normal blood pressure (BP) and pulse rate readings, as defined in the protocol
- Difference between semi-recumbent systolic blood pressure (SBP) measurements in left and right arm less than 20 mmHg at screening visit
- Key
Exclusion
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation
- History, in the past 2 years of a diagnosis of hypertension, symptomatic hypotension (BP \<90/50 mmHg with associated symptoms), symptomatic orthostatic hypotension, postural orthostatic tachycardia syndrome, syncope, or clinically significant cardiac arrhythmia
- Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
- Was hospitalized (ie, \>24 hours) for any reason within 30 days of screening
- Is a current smoker or former smoker, including e-cigarettes, who stopped smoking within 3 months prior to screening
- NOTE: Other protocol defined inclusion / exclusion criteria apply
Key Trial Info
Start Date :
August 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05970718
Start Date
August 7 2023
End Date
July 22 2024
Last Update
August 12 2024
Active Locations (1)
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1
New Zealand Clinical Research
Christchurch, New Zealand, 8011