A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants

Study Overview
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Brief Summary
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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)

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7544, an Antagonistic Monoclonal Antibody to NPR1, in Healthy Adults

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: REGN7544
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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Key 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Dose Level 1<br>Randomized 6:2 for single ascending IV dose | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|
| Experimental: IV Dose Level 2<br>Randomized 6:2 for single ascending IV dose | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|
| Experimental: IV Dose Level 3<br>Randomized 6:2 for single ascending IV dose | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|
| Experimental: IV Dose Level 4<br>Randomized 6:2 for single ascending IV dose | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|
| Experimental: IV Dose Level 5<br>Randomized 6:2 for single ascending IV dose | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|
| Experimental: IV Dose Level 6<br>Randomized 6:2 for single ascending IV dose | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|
| Experimental: SC Dose Level 1<br>Randomized 6:2 for single ascending SC dose | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|
| Experimental: SC Dose Level 2<br>Randomized 6:2 for single ascending SC dose | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|
| Experimental: SC Dose Level 3<br>Randomized 6:2 for single ascending SC dose | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|
| Experimental: Optional Cohort 1<br>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 | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|
| Experimental: Optional Cohort 2<br>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 | Drug: REGN7544<br>* Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration<br>Drug: Matching Placebo<br>* Solution for single ascending IV or SC administration per the protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Emergent Adverse Events (TEAEs) |  | Through approximately day 162 | 
| Severity of TEAEs |  | Through approximately day 162 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Systolic Blood Pressure (SBP) |  | Through day 6 | 
| 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 | 
| Concentrations of REGN7544 in serum over time |  | Through approximately day 162 | 
| Incidence of treatment-emergent Anti-Drug Antibody (ADA) |  | Through approximately day 162 | 
| Titer of ADA |  | Through approximately day 162 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypotension and/or hypovolemia