Safety, Tolerability, PK, Immunogenicity & PD of JNJ-64179375
Research type
Research Study
Full title
A 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Japanese Subjects.
IRAS ID
222299
Contact name
Denisa Wilkes
Contact email
Sponsor organisation
Early Development & Clinical Pharmacology Global Clinical Operations, Janssen Research & Development
Eudract number
2016-004785-25
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
We are conducting a study of drug JNJ-64179375 in sixty healthy Japanese volunteers. JNJ-64179375 is an experimental product under development by Janssen Ltd to be used in the prevention or treatment of thrombosis (blood clots). While other therapies exist, all are associated with increased risk of bleeding. This drug is being developed as a potential equivalent or superior treatment to existing therapies, but with reduced risk of bleeding.
Single ascending doses of JNJ-64179375 have been given via intravenous administration to non-Japanese volunteers in an ongoing Phase 1 study in which subcutaneous doses are also planned. No safety concerns have thus far been identified. This study will therefore bridge information gathered from non-Japanese and Japanese volunteers.
This study is split into two parts, and aims to compare and evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses of JNJ-64179375 administered intravenously in Part 1, and a single dose of JNJ-64179375 administered subcutaneously in Part 2. Part 2 will be initiated at least 14 days after the last cohort in Part 1 has been dosed.
We will also assess safety parameters including physical examination, vital sign measurements, laboratory evaluations including coagulation, electrocardiogram (ECG), telemetry and monitoring of adverse events (AEs).
In Part 1, 48 volunteers (in up to 6 cohorts of 8 volunteers each) will be randomly assigned to receive a single ascending dose of JNJ-64179375 (or placebo) via intravenous infusion; In Part 2, 12 volunteers (in 1 cohort) will be randomly assigned to receive a single dose of JNJ-64179375 (or placebo) via sub-cutaneous injection. Each study part will consist of a screening phase (up to 28 days), a double-blind inpatient period (14 days) and an outpatient period (approximately 99 days). Total study duration will be approximately 20 weeks for each volunteer.
REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/0174
Date of REC Opinion
27 Feb 2017
REC opinion
Favourable Opinion