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

NCT ID: NCT04616079

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2021-06-01

Brief Summary

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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

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IV Cohort 1

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

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

IV Cohort 2

Single IV dose 2 of REGN6490 or matching placebo

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

IV Cohort 3

Single IV dose 3 of REGN6490 or matching placebo

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

IV Cohort 4

Single IV dose 4 of REGN6490 or matching placebo

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

IV Cohort 5

Single IV dose 5 of REGN6490 or matching placebo

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

SC Cohort 1

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

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

SC Cohort 2

Single SC dose 2 of REGN6490 or matching placebo

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

SC Cohort 3

Single SC dose 2 of REGN6490 or matching placebo

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

Interventions

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REGN6490

Single dose of REGN6490

Intervention Type DRUG

Placebo

Placebo matching single dose of REGN6490

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Study Site

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2020-003261-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R6490-HV-1946

Identifier Type: -

Identifier Source: org_study_id