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

NCT05970718 | Completed Phase 1

• 1 other identifier: R7544-HV-22109
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Healthy Volunteers

Keywords

Hypotension and/or hypovolemia

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  Through approximately day 162

• Severity of TEAEs

  Through approximately day 162

Secondary Outcomes (7)

• 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

Study Arms (11)

IV Dose Level 1

EXPERIMENTAL

Randomized 6:2 for single ascending IV dose

Drug: REGN7544; Drug: Matching Placebo

IV Dose Level 2

EXPERIMENTAL

Randomized 6:2 for single ascending IV dose

Drug: REGN7544; Drug: Matching Placebo

IV Dose Level 3

EXPERIMENTAL

Randomized 6:2 for single ascending IV dose

Drug: REGN7544; Drug: Matching Placebo

IV Dose Level 4

EXPERIMENTAL

Randomized 6:2 for single ascending IV dose

Drug: REGN7544; Drug: Matching Placebo

IV Dose Level 5

EXPERIMENTAL

Randomized 6:2 for single ascending IV dose

Drug: REGN7544; Drug: Matching Placebo

IV Dose Level 6

EXPERIMENTAL

Randomized 6:2 for single ascending IV dose

Drug: REGN7544; Drug: Matching Placebo

SC Dose Level 1

EXPERIMENTAL

Randomized 6:2 for single ascending SC dose

Drug: REGN7544; Drug: Matching Placebo

SC Dose Level 2

EXPERIMENTAL

Randomized 6:2 for single ascending SC dose

Drug: REGN7544; Drug: Matching Placebo

SC Dose Level 3

EXPERIMENTAL

Randomized 6:2 for single ascending SC dose

Drug: REGN7544; Drug: Matching Placebo

Optional Cohort 1

EXPERIMENTAL

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; Drug: Matching Placebo

Optional Cohort 2

EXPERIMENTAL

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; Drug: Matching Placebo

Interventions

REGN7544 DRUG

Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

IV Dose Level 1; IV Dose Level 2; IV Dose Level 3; IV Dose Level 4; IV Dose Level 5; IV Dose Level 6; Optional Cohort 1; Optional Cohort 2; SC Dose Level 1; SC Dose Level 2; SC Dose Level 3

Matching Placebo DRUG

Solution for single ascending IV or SC administration per the protocol

IV Dose Level 1; IV Dose Level 2; IV Dose Level 3; IV Dose Level 4; IV Dose Level 5; IV Dose Level 6; Optional Cohort 1; Optional Cohort 2; SC Dose Level 1; SC Dose Level 2; SC Dose Level 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

New Zealand Clinical Research

Christchurch, 8011, New Zealand

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: August 7, 2023
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

NZ (1)