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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05970718
Collaborator
(none)
88
Enrollment
11
Arms
13.4
Anticipated Duration (Months)

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 2, 2023
Anticipated Primary Completion Date :
Sep 13, 2024
Anticipated Study Completion Date :
Sep 13, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: IV Dose Level 1

Randomized 6:2 for single ascending IV dose

Drug: REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Experimental: IV Dose Level 2

Randomized 6:2 for single ascending IV dose

Drug: REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Experimental: IV Dose Level 3

Randomized 6:2 for single ascending IV dose

Drug: REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Experimental: IV Dose Level 4

Randomized 6:2 for single ascending IV dose

Drug: REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Experimental: IV Dose Level 5

Randomized 6:2 for single ascending IV dose

Drug: REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Experimental: IV Dose Level 6

Randomized 6:2 for single ascending IV dose

Drug: REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Experimental: SC Dose Level 1

Randomized 6:2 for single ascending SC dose

Drug: REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Experimental: SC Dose Level 2

Randomized 6:2 for single ascending SC dose

Drug: REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Experimental: SC Dose Level 3

Randomized 6:2 for single ascending SC dose

Drug: REGN7544
Solution for single ascending Intravenous (IV) or Subcutaneous (SC) administration

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Experimental: Optional Cohort 1

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

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol
Experimental: Optional Cohort 2

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

Drug: Matching Placebo
Solution for single ascending IV or SC administration per the protocol

Outcome Measures

Primary Outcome Measures

  1. Incidence of Treatment Emergent Adverse Events (TEAEs) [Through approximately day 162]

  2. Severity of TEAEs [Through approximately day 162]

Secondary Outcome Measures

  1. Changes from baseline in Systolic Blood Pressure (SBP) [Through day 6]

  2. Changes from baseline in Diastolic Blood Pressure (DBP) [Through day 6]

  3. Changes from baseline in Mean Arterial Pressure (MAP) [Through day 6]

  4. Changes from baseline in Pulse Pressure (PP) [Through day 6]

  5. Concentrations of REGN7544 in serum over time [Through approximately day 162]

  6. Incidence of treatment-emergent Anti-Drug Antibody (ADA) [Through approximately day 162]

  7. Titer of ADA [Through approximately day 162]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05970718
Other Study ID Numbers:
  • R7544-HV-22109
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Regeneron Pharmaceuticals
Hypotension and/or hypovolemia

Study Results

No Results Posted as of Aug 1, 2023