drugset / Trial / NCT05423106
A Single and Multiple Ascending Dose Study of JNJ-64457744
RandomizedSequentialDouble-blindTreatment
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).
Timeline
- Start
- 2022-07-04
- Primary completion
- 2023-03-14
- Completion
- 2023-03-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JNJ-64457744 | Unknown | — | Oral |
| Background | Entecavir | Small molecule | — | Oral |
| Background | Tenofovir disoproxil fumarate | Small molecule | — | Oral |
| Background | tenofovir alafenamide | Small molecule | — | Oral |