NCT05017116

A Single and Repeated Dose Escalation of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection

A Single and Repeated Dose Escalation, Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Preliminary Pharmacodynamics of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Suzhou Ribo Life Science Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, single (Part A) and repeated dose (Part B) escalation, phase I clinical study to evaluate the safety, pharmacokinetics (PK) and preliminary pharmacodynamics (PD) of RBD1016 in subjects with chronic HBV infection.

Detailed description

The study consists of two parts. Part A is the single dose escalation study where subjects with chronic HBV infection will be assigned to receive single dose of RBD1016 or placebo . Part B is the multiple dose escalation study where subjects with chronic HBV infection will be assigned to receive two doses of RBD1016 or placebo.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	RBD1016	subcutaneous injection
DRUG	Placebo	subcutaneous injection
DRUG	Entecavir	Take orally.

Timeline

• Start date: 2021-08-09
• Primary completion: 2023-10-25
• Completion: 2023-10-25
• First posted: 2021-08-23
• Last updated: 2024-12-06

Locations

1 site across 1 country: China