A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Japanese Subjects and An Open-label, Single Dose Study to Assess Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Caucasian Subjects

Registration

Registration

NCT03618160

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

TERMINATED

Enrollment

42

Start

2018-08-06

Primary completion

2019-06-21

Lead sponsor

Janssen Pharmaceutical K.K.

Conditions

Healthy

Interventions

DRUG:JNJ-64565111; DRUG:Placebo

Results posted

FALSE

Secondary identifiers

OTHER:64565111NAS1001

Registered primary outcomes

• Part 1 and Part 3: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability [Up to Day 35]
• Part 1: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111 [Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose]
• Part 1: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111 [Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose]
• Part 1: Area Under Serum Concentration Curve From Time 0 to Time of the Last Measurable Concentration (AUC[0-Last]) of JNJ-64565111 [Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose]
• Part 1: Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC[0-Infinity]) of JNJ-64565111 [Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose]
• Part 1: Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111 [Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose]
• Part 1: Apparent Volume of Distribution (V/F) of JNJ-64565111 [Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose]
• Part 1: Total Apparent Clearance (CL/F) of JNJ-64565111 [Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose]
• Part 2: Number of Participants With AEs as a Measure of Safety and Tolerability [Up to Day 72]
• Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111 [Day 1: Predose, 8, 24, 48, 72, 120 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose]
• Part 2: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111 [Day 1: Predose, 8, 24, 48, 72, 120 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose]
• Part 2: Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111 [Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose]
• Part 2: Apparent Volume of Distribution (V/F) of JNJ-64565111 [Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose]
• Part 2: Total Apparent Clearance (CL/F) of JNJ-64565111 [Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose]
• Part 2: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-64565111 [Day 1: Predose, 8, 24, 48, 72, 120, 168 hours postdose; Day 22: 72, 96, 144, 168 hours postdose]
• Part 2: Observed Serum Concentration Just Prior to the Beginning or the End of a Dosing Interval (Ctrough) of JNJ-64565111 [Day 8: Predose ; Day 15: Predose; Day 22: Predose, 168 hours postdose]
• Part 2: Average Concentration Over the Dosing Interval Tau (T) at Steady State (Caverage,ss) of JNJ-64565111 [Day 22: Predose, 72, 96, 144, 168 hours postdose]
• Part 2: Observed Accumulation Index (AR-AUC) of JNJ-64565111 [Day 1: Predose, 8, 24, 48, 72, 120, 168 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose]