Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers

NCT03645746 | Completed Phase 1 FDA Drug

• 2 other identifiers: R5069-HV-18102018-000651-41
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  From baseline up to week 36

• Incidence of laboratory abnormalities

  As measured by chemistry, hematology and urinalysis

  From baseline up to week 36

• Incidence of vital signs abnormalties

  As measured by heart rate, blood pressure, body temperature and respiratory rate

  From baseline up to week 36

• 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 Outcomes (2)

• Concentration of REGN5069 in serum over time

  From baseline up to week 36

• Incidence of anti-drug antibody (ADA)

  From baseline up to week 36

Study Arms (7)

Cohort 1

EXPERIMENTAL

Cohort 1 will receive a single IV dose of REGN5069 or matching placebo

Drug: REGN5069; Drug: Placebo

Cohort 2

EXPERIMENTAL

Cohort 2 will receive a single sequential ascending IV dose of REGN5069 or matching placebo

Drug: REGN5069; Drug: Placebo

Cohort 3

EXPERIMENTAL

Cohort 3 will receive a single sequential ascending IV dose of REGN5069 or matching placebo

Drug: REGN5069; Drug: Placebo

Cohort 4

EXPERIMENTAL

Cohort 4 will receive a single sequential ascending IV dose of REGN5069 or matching placebo

Drug: REGN5069; Drug: Placebo

Cohort 5

EXPERIMENTAL

Cohort 5 will receive a single SC dose of REGN5069 or matching placebo

Drug: REGN5069; Drug: Placebo

Cohort 6

EXPERIMENTAL

Cohort 6 will receive a single sequential ascending SC dose of REGN5069 or matching placebo

Drug: REGN5069; Drug: Placebo

Cohort 7

EXPERIMENTAL

Cohort 7 will receive a single sequential ascending IV dose of REGN5069 or matching placebo

Drug: REGN5069; Drug: Placebo

Interventions

REGN5069 DRUG

REGN5069 will be administered by IV infusion or SC injection

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Placebo DRUG

Placebo-matching REGN5069

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Regeneron Research Facility

Ghent, B-9000, 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: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: August 23, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

BE (1)