NCT03439488

A Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation; After Multi-Day Dosing in Healthy Participants; and After Multiple (Ascending) Doses in Participants With Chronic Hepatitis B

A Multipart Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human, Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation (Part 1); After Multi-Day Dosing (Part 2) in Healthy Subjects; and After Multiple (Ascending) Doses in Subjects With Chronic Hepatitis B (Part 3)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Alios Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of JNJ-440 in healthy and Chronic Hepatitis B (CHB) participants after single and multiple doses; and to evaluate the pharmacokinetic (PK) of JNJ-440 in healthy participants and in CHB participants following single and multiple dose regimens, administered alone (healthy participants and CHB participants).

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	JNJ-440	JNJ-440 will be administered as oral tablets in Parts 1, 2 and 3. JNJ-440 may be provided as oral solution in a cohort in Part 1.
DRUG	Placebo	Matching placebo as oral tablets will be administered in Parts 1, 2 and 3.

Timeline

• Start date: 2018-03-26
• Primary completion: 2019-10-10
• Completion: 2019-10-10
• First posted: 2018-02-20
• Last updated: 2025-02-03

Locations

7 sites across 5 countries: Moldova, New Zealand, South Korea, Thailand, Ukraine

Regulatory

• FDA-regulated drug study