NCT05423106

A Single and Multiple Ascending Dose Study of JNJ-64457744

A Phase 1, Blinded, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-64457744 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Ascending Doses

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety and tolerability of: single ascending dose (SAD) and multiple ascending dose (MAD) administration of JNJ-64457744, administered to healthy adult participants (Part 1 and Part 3), including a cohort of Asian participants (Part 1); and after single dose administration of JNJ-64457744 to chronic hepatitis B (CHB) participants who are virologically suppressed on nucleos(t)ide analog (NA) treatment (tenofovir disoproxil fumarate \[TDF\], tenofovir alafenamide \[TAF\], or entecavir \[ETV\]) (Part 2).

Conditions

• Healthy
• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	JNJ-64457744	JNJ-64457744 will be administered as oral solution.
DRUG	Placebo	Placebo will be administered as an oral formulation.
DRUG	Tenofovir Disoproxil Fumarate (TDF)	TDF tablet will be administered orally
DRUG	Tenofovir Alafenamide (TAF)	TAF tablet will be administered orally.
DRUG	Entecavir (ETV)	ETV tablet will be administered orally.
DRUG	JNJ-64457744	JNJ-64457744 will be administered as oral tablet.

Timeline

• Start date: 2022-07-04
• Primary completion: 2023-03-14
• Completion: 2023-03-20
• First posted: 2022-06-21
• Last updated: 2025-02-03

Locations

1 site across 1 country: New Zealand