A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants
- Registration Number
- NCT05970718
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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 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 your 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description IV Dose Level 5 REGN7544 Randomized 6:2 for single ascending IV dose IV Dose Level 3 Matching Placebo Randomized 6:2 for single ascending IV dose IV Dose Level 4 Matching Placebo Randomized 6:2 for single ascending IV dose SC Dose Level 1 REGN7544 Randomized 6:2 for single ascending SC dose SC Dose Level 3 Matching Placebo Randomized 6:2 for single ascending SC dose IV Dose Level 1 Matching Placebo Randomized 6:2 for single ascending IV dose IV Dose Level 2 Matching Placebo Randomized 6:2 for single ascending IV dose IV Dose Level 5 Matching Placebo Randomized 6:2 for single ascending IV dose IV Dose Level 6 Matching Placebo Randomized 6:2 for single ascending IV dose SC Dose Level 2 Matching Placebo Randomized 6:2 for single ascending SC dose IV Dose Level 1 REGN7544 Randomized 6:2 for single ascending IV dose SC Dose Level 1 Matching Placebo Randomized 6:2 for single ascending SC dose Optional Cohort 1 REGN7544 Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV or SC and will not exceed highest dose level Optional Cohort 1 Matching Placebo Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV or SC and will not exceed highest dose level Optional Cohort 2 Matching Placebo Randomized 6:2 Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV o SC and will not exceed highest dose level IV Dose Level 3 REGN7544 Randomized 6:2 for single ascending IV dose IV Dose Level 4 REGN7544 Randomized 6:2 for single ascending IV dose IV Dose Level 2 REGN7544 Randomized 6:2 for single ascending IV dose IV Dose Level 6 REGN7544 Randomized 6:2 for single ascending IV dose SC Dose Level 2 REGN7544 Randomized 6:2 for single ascending SC dose SC Dose Level 3 REGN7544 Randomized 6:2 for single ascending SC dose Optional Cohort 2 REGN7544 Randomized 6:2 Randomized 6:2 for single ascending dose This is an optional cohort, that may be IV o SC and will not exceed highest dose level
- Primary Outcome Measures
Name Time Method Incidence of Treatment Emergent Adverse Events (TEAEs) Through approximately day 162 Severity of TEAEs Through approximately day 162
- Secondary Outcome Measures
Name Time Method Concentrations of REGN7544 in serum over time Through approximately day 162 Changes from baseline in Systolic Blood Pressure (SBP) Through day 6 Titer of ADA Through approximately day 162 Changes from baseline in Diastolic Blood Pressure (DBP) Through day 6 Changes from baseline in Mean Arterial Pressure (MAP) Through day 6 Changes from baseline in Pulse Pressure (PP) Through day 6 Incidence of treatment-emergent Anti-Drug Antibody (ADA) Through approximately day 162
Trial Locations
- Locations (1)
New Zealand Clinical Research
🇳🇿Christchurch, New Zealand