Safety, Tolerability, and Pharmacokinetics of REGN5069 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 Intravenously or Subcutaneously Administered REGN5069 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645746
• Other study ID #: R5069-HV-1810
• Secondary ID: 2018-000651-41
• Status: Completed
• Phase: Phase 1
• Start date: August 23, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2019
• 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 doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants.

The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed at screening and/or prior to study drug dosing

• Participant 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 or legally acceptable representative

Key Exclusion Criteria:

• History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease

• Has any physical examination findings and/or history of any illness that might confound the results of the study or poses an additional risk to the subject by study participation

• Hospitalization for any reason within 60 days of the screening visit

• Current cigarette smoker or former smoker (cigarettes or e-cigarettes) who stopped smoking within 3 months prior to screening

• History of drug or alcohol abuse within a year prior to the screening visit

• Presence of HIV, hepatitis B, or hepatitis C seropositivity at screening or within 3 months prior to dosing with the exception of false positive screening tests as documented by polymerase chain reaction or Western blot

• Any malignancy within the past 5 years, except for basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus, that have been resected, with no evidence of metastatic disease for 3 years

Note: Other protocol Inclusion/Exclusion Criteria apply

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• REGN5069
REGN5069 will be administered by IV infusion or SC injection
• Placebo
Placebo-matching REGN5069

Locations

Country	Name	City	State
Belgium	Regeneron Research Facility	Gent

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)		From baseline up to week 36
Primary	Incidence of laboratory abnormalities	As measured by chemistry, hematology and urinalysis	From baseline up to week 36
Primary	Incidence of vital signs abnormalties	As measured by heart rate, blood pressure, body temperature and respiratory rate	From baseline up to week 36
Primary	Incidence of standard 12-lead electrocardiogram (ECG) abnormalties	As measured by heart rate, PR, complex of Q, R, and S waves [QRS], QT-intervals, and QTc	From baseline up to week 36
Secondary	Concentration of REGN5069 in serum over time		From baseline up to week 36
Secondary	Incidence of anti-drug antibody (ADA)		From baseline up to week 36