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

Healthy Volunteer Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of REGN6490 in Healthy Volunteers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04616079
• Other study ID #: R6490-HV-1946
• Secondary ID: 2020-003261-19
• Status: Terminated
• Phase: Phase 1
• Start date: November 19, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: November 2021
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• REGN6490
Single dose of REGN6490
• Placebo
Placebo matching single dose of REGN6490

Locations

Country	Name	City	State
Belgium	Regeneron Study Site	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)	TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs)	Up to Week 16
Secondary	Serum Concentration of REGN6490 over time		Up to Week 16
Secondary	Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs)		Up to Week 16