A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 14, 2016

Primary Completion Date

August 9, 2017

Study Completion Date

August 9, 2017

Conditions
Healthy
Interventions
DRUG

JNJ-64179375

During part 1, participants will receive a single ascending Intravenous dose of JNJ-64179375 ranging from (0.03 mg/kg to 5.0 mg/kg). In Part 2, participants will receive a 2.5 mg/kg or highest tolerable dose if lower than 2.5 mg/kg of JNJ-64179375. In Part 3, participants will receive a Single Subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375.

DRUG

Placebo

Participants will randomly receive matching placebo in all 3 Parts on day 1 administered via IV Route (for Part 1 and 2) and SC route (for Part 3).

DRUG

4 Factor Prothrombin Complex Concentrate (PCC)

Following a single dose of JNJ-64179375, participants will receive a single IV dose of 4 factor-PCC.

Trial Locations (1)

Unknown

Merksem

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02949206 - A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects | Biotech Hunter | Biotech Hunter