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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT04616079
Collaborator
(none)
57
1
8
6.4
8.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of REGN6490 in Healthy Volunteers
Actual Study Start Date :
Nov 19, 2020
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: IV Cohort 1

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

Drug: REGN6490
Single dose of REGN6490

Drug: Placebo
Placebo matching single dose of REGN6490

Experimental: IV Cohort 2

Single IV dose 2 of REGN6490 or matching placebo

Drug: REGN6490
Single dose of REGN6490

Drug: Placebo
Placebo matching single dose of REGN6490

Experimental: IV Cohort 3

Single IV dose 3 of REGN6490 or matching placebo

Drug: REGN6490
Single dose of REGN6490

Drug: Placebo
Placebo matching single dose of REGN6490

Experimental: IV Cohort 4

Single IV dose 4 of REGN6490 or matching placebo

Drug: REGN6490
Single dose of REGN6490

Drug: Placebo
Placebo matching single dose of REGN6490

Experimental: IV Cohort 5

Single IV dose 5 of REGN6490 or matching placebo

Drug: REGN6490
Single dose of REGN6490

Drug: Placebo
Placebo matching single dose of REGN6490

Experimental: SC Cohort 1

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

Drug: REGN6490
Single dose of REGN6490

Drug: Placebo
Placebo matching single dose of REGN6490

Experimental: SC Cohort 2

Single SC dose 2 of REGN6490 or matching placebo

Drug: REGN6490
Single dose of REGN6490

Drug: Placebo
Placebo matching single dose of REGN6490

Experimental: SC Cohort 3

Single SC dose 2 of REGN6490 or matching placebo

Drug: REGN6490
Single dose of REGN6490

Drug: Placebo
Placebo matching single dose of REGN6490

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [Up to Week 16]

    TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs)

Secondary Outcome Measures

  1. Serum Concentration of REGN6490 over time [Up to Week 16]

  2. Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs) [Up to Week 16]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regeneron Study Site Ghent Belgium

Sponsors and Collaborators

  • Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04616079
Other Study ID Numbers:
  • R6490-HV-1946
  • 2020-003261-19
First Posted:
Nov 4, 2020
Last Update Posted:
Nov 11, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 11, 2021