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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Matching Placebo; Drug: REGN7544

Study type: Interventional

Funder types: Industry

Identifiers

NCT05970718

R7544-HV-22109

Details and patient eligibility

About

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)

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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80 participants in 11 patient groups

IV Dose Level 1

Experimental group

Description:

Randomized 6:2 for single ascending IV dose

Treatment:

Drug: REGN7544

Drug: Matching Placebo

IV Dose Level 2

Experimental group

Description:

Randomized 6:2 for single ascending IV dose

Treatment:

Drug: REGN7544

Drug: Matching Placebo

IV Dose Level 3

Experimental group

Description:

Randomized 6:2 for single ascending IV dose

Treatment:

Drug: REGN7544

Drug: Matching Placebo

IV Dose Level 4

Experimental group

Description:

Randomized 6:2 for single ascending IV dose

Treatment:

Drug: REGN7544

Drug: Matching Placebo

IV Dose Level 5

Experimental group

Description:

Randomized 6:2 for single ascending IV dose

Treatment:

Drug: REGN7544

Drug: Matching Placebo

IV Dose Level 6

Experimental group

Description:

Randomized 6:2 for single ascending IV dose

Treatment:

Drug: REGN7544

Drug: Matching Placebo

SC Dose Level 1

Experimental group

Description:

Randomized 6:2 for single ascending SC dose

Treatment:

Drug: REGN7544

Drug: Matching Placebo

SC Dose Level 2

Experimental group

Description:

Randomized 6:2 for single ascending SC dose

Treatment:

Drug: REGN7544

Drug: Matching Placebo

SC Dose Level 3

Experimental group

Description:

Randomized 6:2 for single ascending SC dose

Treatment:

Drug: REGN7544

Drug: Matching Placebo

Optional Cohort 1

Experimental group

Description:

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

Treatment:

Drug: REGN7544

Drug: Matching Placebo

Optional Cohort 2

Experimental group

Description:

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

Treatment:

Drug: REGN7544

Drug: Matching Placebo