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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05970718
• Other study ID #: R7544-HV-22109
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 7, 2023
• Est. completion date: September 11, 2024

Study information

• Verified date: April 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 11, 2024
• Est. primary completion date: September 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration
• Matching Placebo
Solution for single ascending IV or SC administration per the protocol

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events (TEAEs)		Through approximately day 162
Primary	Severity of TEAEs		Through approximately day 162
Secondary	Changes from baseline in Systolic Blood Pressure (SBP)		Through day 6
Secondary	Changes from baseline in Diastolic Blood Pressure (DBP)		Through day 6
Secondary	Changes from baseline in Mean Arterial Pressure (MAP)		Through day 6
Secondary	Changes from baseline in Pulse Pressure (PP)		Through day 6
Secondary	Concentrations of REGN7544 in serum over time		Through approximately day 162
Secondary	Incidence of treatment-emergent Anti-Drug Antibody (ADA)		Through approximately day 162
Secondary	Titer of ADA		Through approximately day 162