drugset / Trial / NCT02797522
A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo. The maximum study duration for NHVs is approximately 21 weeks. Hepatitis B e Antigen (HBeAg)-negative participants with (CHB) will enroll sequentially into 3 dose levels (8 patients per dose level) to receive multiple doses of open label ARC-521 Injection. For each CHB participant the maximum study duration is approximately 37 weeks.
Timeline
- Start
- 2016-06
- Primary completion
- 2016-11
- Completion
- 2016-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARC-521 | Unknown | 0.6 mg/kg | — |
| Subject | ARC-521 | Unknown | 1 mg/kg | — |
| Subject | ARC-521 | Unknown | 2 mg/kg | — |
| Subject | ARC-521 | Unknown | 4 mg/kg | — |
| Subject | ARC-521 | Unknown | 5 mg/kg | — |
| Subject | ARC-521 | Unknown | 6 mg/kg | — |
| Background | Acetaminophen | Small molecule | 500 mg | Oral |
| Background | Acetaminophen | Small molecule | 1000 mg | Oral |
| Background | Chlorpheniramine | Unknown | 8 mg | Oral |
| Background | Diphenhydramine | Unknown | 50 mg | Oral |
| Background | Entecavir | Small molecule | — | — |
| Background | Hydroxyzine | Small molecule | 50 mg | Oral |
| Background | Tenofovir | Small molecule | — | — |