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OpenTrials
Completed

NCT Number: NCT05970718

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

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)

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research

Christchurch, 8011, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REGN7544

Drug

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

Matching Placebo

Drug

Solution for single ascending IV or SC administration per the protocol

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Through approximately day 162

  2. Severity of TEAEs

    Time frame: Through approximately day 162

Secondary outcomes

  1. Changes from baseline in Systolic Blood Pressure (SBP)

    Time frame: Through day 6

  2. Changes from baseline in Diastolic Blood Pressure (DBP)

    Time frame: Through day 6

  3. Changes from baseline in Mean Arterial Pressure (MAP)

    Time frame: Through day 6

  4. Changes from baseline in Pulse Pressure (PP)

    Time frame: Through day 6

  5. Concentrations of REGN7544 in serum over time

    Time frame: Through approximately day 162

  6. Incidence of treatment-emergent Anti-Drug Antibody (ADA)

    Time frame: Through approximately day 162

  7. Titer of ADA

    Time frame: Through approximately day 162

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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