Trials / Completed
CompletedNCT04774107
The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
An Open-label Study to Assess the Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis With HCV Genotype 2 Infection
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- PharmaEssentia · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg.
Detailed description
Secondary Objective: To determine the safety and immunogenicity of P1101 400 μg subcutaneous (SC) single dose + Ribavirin 800-1400 mg PO daily.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | P1101 + Ribavirin | P1101 400 µg SC |
Timeline
- Start date
- 2020-11-26
- Primary completion
- 2022-07-18
- Completion
- 2022-07-18
- First posted
- 2021-03-01
- Last updated
- 2022-08-30
Locations
5 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04774107. Inclusion in this directory is not an endorsement.