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

Sponsor

Ascletis Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05330143

Collaborator

(none)

Enrollment

Location

Arms

9.1

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection HIV Infections PD-L1 Gene Mutation	Drug: ASC22 1mg/kg Drug: ASC22 2.5mg/kg Drug: Antiretroviral Therapy Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 28, 2022

Anticipated Primary Completion Date :

Jan 13, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASC22 1mg/kg ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks	Drug: ASC22 1mg/kg ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week. Other Names: KN035 Drug: Antiretroviral Therapy standard antiretroviral therapy including Integrase inhibitors (INSTIs)
Experimental: ASC22 2.5mg/kg ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks	Drug: ASC22 2.5mg/kg ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week. Other Names: KN035 Drug: Antiretroviral Therapy standard antiretroviral therapy including Integrase inhibitors (INSTIs)
Placebo Comparator: Placebo 0.9% Saline and anti-retroviral therapy for 12 weeks	Drug: Antiretroviral Therapy standard antiretroviral therapy including Integrase inhibitors (INSTIs) Drug: Placebo 0.9% saline vials administered subcutaneously once 4 week.

Arm

Intervention/Treatment

Experimental: ASC22 1mg/kg

ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks

Drug: ASC22 1mg/kg

ASC22 single-dose of 1mg/kg vials administered subcutaneously once 4 week.

Other Names:

KN035

Drug: Antiretroviral Therapy

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

Experimental: ASC22 2.5mg/kg

ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks

Drug: ASC22 2.5mg/kg

ASC22 single-dose of 2.5mg/kg vials administered subcutaneously once 4 week.

Other Names:

KN035

Drug: Antiretroviral Therapy

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

Placebo Comparator: Placebo

0.9% Saline and anti-retroviral therapy for 12 weeks

Drug: Antiretroviral Therapy

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

Drug: Placebo

0.9% saline vials administered subcutaneously once 4 week.

Outcome Measures

Primary Outcome Measures

CD4/CD8 ratio changes compared with baseline [Week 4\Week 8\Week 12]

Secondary Outcome Measures

HIV-DNA copy changes compared with baselnie [Week 12]
CD4+ count changes compared with baseline [Week 12]
CD8+ count changes compared with baseline [Week 12]
HLA-DR number changes compared with baseline [Week 12]
CD38 count changes compared with baseline [Week 12]
IL-2 concentration changes compared with baseline [Week 4\Week 8\Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18 and ≤ 75 years old at screening.
Treated with anti-retroviral medicine continuously for at least 12 months within 6 months of diagnosis of HIV-1 infection.
Treated with anti-retroviral medicine continuously, contain integrase inhibitor, for at least months before screening.
CD4+ Cell count ≥300 cells/μL and CD4+/ CD8+ratio ≤ 0.9 at screening.
Weight ≥ 50 kg at screening.