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

NCT ID: NCT05970718

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2024-07-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IV Dose Level 1

Randomized 6:2 for single ascending IV dose

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

IV Dose Level 2

Randomized 6:2 for single ascending IV dose

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

IV Dose Level 3

Randomized 6:2 for single ascending IV dose

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

IV Dose Level 4

Randomized 6:2 for single ascending IV dose

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

IV Dose Level 5

Randomized 6:2 for single ascending IV dose

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

IV Dose Level 6

Randomized 6:2 for single ascending IV dose

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

SC Dose Level 1

Randomized 6:2 for single ascending SC dose

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

SC Dose Level 2

Randomized 6:2 for single ascending SC dose

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

SC Dose Level 3

Randomized 6:2 for single ascending SC dose

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

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

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

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

Group Type: EXPERIMENTAL

REGN7544

Intervention Type: DRUG

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

Matching Placebo

Intervention Type: DRUG

Solution for single ascending IV or SC administration per the protocol

Interventions

REGN7544

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

Intervention Type: DRUG

Matching Placebo

Solution for single ascending IV or SC administration per the protocol

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

New Zealand Clinical Research

Christchurch, , New Zealand

Countries

New Zealand

Other Identifiers

R7544-HV-22109

Identifier Type: -

Identifier Source: org_study_id