Clinical trial NCT05970718: A Trial to Learn if Different Doses of REGN7544 Are Safe in Healthy Adult Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Hypotension and/or hypovolemia
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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)


Eligibility criteria: Key Inclusion Criteria:

1. Has a body mass index between 18 and 32 kg/m\^2
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
3. Has normal blood pressure (BP) and pulse rate readings, as defined in the protocol
4. Difference between semi-recumbent systolic blood pressure (SBP) measurements in left and right arm less than 20 mmHg at screening visit

Key Exclusion Criteria:

1. 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
2. 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
3. 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
4. Was hospitalized (ie, \>24 hours) for any reason within 30 days of screening
5. 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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Through approximately day 162
measure: Severity of TEAEs
timeFrame: Through approximately day 162
Secondary outcomes:
measure: Changes from baseline in Systolic Blood Pressure (SBP)
timeFrame: Through day 6
measure: Changes from baseline in Diastolic Blood Pressure (DBP)
timeFrame: Through day 6
measure: Changes from baseline in Mean Arterial Pressure (MAP)
timeFrame: Through day 6
measure: Changes from baseline in Pulse Pressure (PP)
timeFrame: Through day 6
measure: Concentrations of REGN7544 in serum over time
timeFrame: Through approximately day 162
measure: Incidence of treatment-emergent Anti-Drug Antibody (ADA)
timeFrame: Through approximately day 162
measure: Titer of ADA
timeFrame: Through approximately day 162
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: