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

NCT04616079 | Terminated Phase 1

• 2 other identifiers: R6490-HV-19462020-003261-19
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)

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

  Up to Week 16

Secondary Outcomes (2)

• Serum Concentration of REGN6490 over time

  Up to Week 16

• Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs)

  Up to Week 16

Study Arms (8)

IV Cohort 1

EXPERIMENTAL

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

Drug: REGN6490; Drug: Placebo

IV Cohort 2

EXPERIMENTAL

Single IV dose 2 of REGN6490 or matching placebo

Drug: REGN6490; Drug: Placebo

IV Cohort 3

EXPERIMENTAL

Single IV dose 3 of REGN6490 or matching placebo

Drug: REGN6490; Drug: Placebo

IV Cohort 4

EXPERIMENTAL

Single IV dose 4 of REGN6490 or matching placebo

Drug: REGN6490; Drug: Placebo

IV Cohort 5

EXPERIMENTAL

Single IV dose 5 of REGN6490 or matching placebo

Drug: REGN6490; Drug: Placebo

SC Cohort 1

EXPERIMENTAL

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

Drug: REGN6490; Drug: Placebo

SC Cohort 2

EXPERIMENTAL

Single SC dose 2 of REGN6490 or matching placebo

Drug: REGN6490; Drug: Placebo

SC Cohort 3

EXPERIMENTAL

Single SC dose 2 of REGN6490 or matching placebo

Drug: REGN6490; Drug: Placebo

Interventions

REGN6490 DRUG

Single dose of REGN6490

IV Cohort 1; IV Cohort 2; IV Cohort 3; IV Cohort 4; IV Cohort 5; SC Cohort 1; SC Cohort 2; SC Cohort 3

Placebo DRUG

Placebo matching single dose of REGN6490

IV Cohort 1; IV Cohort 2; IV Cohort 3; IV Cohort 4; IV Cohort 5; SC Cohort 1; SC Cohort 2; SC Cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index between 18 and 31 kg/m2 (inclusive) at screening visit
• 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
• Is in good health based on laboratory safety testing obtained at the screening visit
• Willing and able to comply with clinic visits and study-related procedures
• Provide informed consent signed by study participant

You may not qualify if:

• 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
• 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
• 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
• Hospitalization (\>24 hours) for any reason within 30 days of the screening visit
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Regeneron Study Site

Ghent, Belgium

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: November 19, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (eg, FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Locations

BE (1)