NCT05330143

Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV

A Phase II Multi-center, Randomized, Blind, Placebo-controlled Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With Human Immunodeficiency Virus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase II, multicenter, randomized, blind, placebo-controlled to evaluate the safety, tolerance, efficacy of ASC22 injection in combination with anti-retroviral therapy to treat subjects living with human immunodeficiency virus type 1.

Conditions

• HIV-1-infection
• HIV Infections
• PD-L1 Gene Mutation

Interventions

Type	Name	Description
DRUG	ASC22 1mg/kg	ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.
DRUG	ASC22 2.5mg/kg	ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week.
DRUG	Antiretroviral Therapy	standard antiretroviral therapy including Integrase inhibitors (INSTIs)
DRUG	Placebo	0.9% saline vials administered subcutaneously once 4 week.

Timeline

• Start date: 2022-06-28
• Primary completion: 2024-05-15
• Completion: 2024-05-15
• First posted: 2022-04-15
• Last updated: 2024-11-25

Locations

1 site across 1 country: China