Ascending Dose Study of the Safety and Tolerability of REGN6490 in Healthy Volunteers

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: REGN6490

Study type: Interventional

Funder types: Industry

Identifiers

NCT04616079

R6490-HV-1946

2020-003261-19 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN6490 in healthy adult participants

The secondary objectives of the study are to:

• Characterize the pharmacokinetic (PK) profile of single IV and SC doses of REGN6490 in healthy adult participants
• Assess immunogenicity of REGN6490 in healthy adult participants dosed with a single IV or SC dose of REGN6490

Enrollment: 57 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Body mass index between 18 and 31 kg/m2 (inclusive) at screening visit
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG's performed at screening and/or prior to administration of initial dose of study drug
3. Is in good health based on laboratory safety testing obtained at the screening visit
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide informed consent signed by study participant

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, dermatological, 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. 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
3. Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by study participation
4. Hospitalization (>24 hours) for any reason within 30 days of the screening visit
5. Is a current smoker, including e-cigarettes. Former smokers may be enrolled if they have stopped smoking for at least 3 months (90 days) prior to the screening visit

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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57 participants in 8 patient groups

IV Cohort 1

Experimental group

Description:

Single intravenous (IV) dose 1 of REGN6490 or matching placebo

Treatment:

Drug: REGN6490

Drug: Placebo

IV Cohort 2

Experimental group

Description:

Single IV dose 2 of REGN6490 or matching placebo

Treatment:

Drug: REGN6490

Drug: Placebo

IV Cohort 3

Experimental group

Description:

Single IV dose 3 of REGN6490 or matching placebo

Treatment:

Drug: REGN6490

Drug: Placebo

IV Cohort 4

Experimental group

Description:

Single IV dose 4 of REGN6490 or matching placebo

Treatment:

Drug: REGN6490

Drug: Placebo

IV Cohort 5

Experimental group

Description:

Single IV dose 5 of REGN6490 or matching placebo

Treatment:

Drug: REGN6490

Drug: Placebo

SC Cohort 1

Experimental group

Description:

Single subcutaneous (SC) dose 1 of REGN6490 or matching placebo

Treatment:

Drug: REGN6490

Drug: Placebo

SC Cohort 2

Experimental group

Description:

Single SC dose 2 of REGN6490 or matching placebo

Treatment:

Drug: REGN6490

Drug: Placebo

SC Cohort 3

Experimental group

Description:

Single SC dose 2 of REGN6490 or matching placebo

Treatment:

Drug: REGN6490

Drug: Placebo