Trials / Completed
CompletedNCT04465890
A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients
Phase IIa Single Dose and Phase IIb Mutiple Dose Clinical Studies to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneously Injected PD-L1 Antibody ASC22 in Patients With Chronic Hepatitis B
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- Ascletis Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and efficacy of ASC22 in the treatment of chronic hepatitis B after single and multiple drug administration.
Detailed description
The study consists of two parts: the ASC22 single-dose IIa study and the ASC22 multi-dose IIb study. The IIa study consists of 3 cohorts of 0.3mg/kg, 1.0mg/kg and 2.5mg/kg, and the IIb study consists of 2 cohorts of 1.0mg/kg and 2.5mg/kg. The objective is to evaluate the safety, tolerance and efficacy of ASC22 in patients with chronic hepatitis B (CHB), and to provide a guidance for the determination of dosage regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ASC22 | 200mg/1ml/1bottle |
| DRUG | sodium chloride | 90mg/10ml/1 bottle |
Timeline
- Start date
- 2020-07-17
- Primary completion
- 2024-08-09
- Completion
- 2024-08-09
- First posted
- 2020-07-10
- Last updated
- 2024-12-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04465890. Inclusion in this directory is not an endorsement.