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

Primary Purpose

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

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

ASC22 1mg/kg

ASC22 2.5mg/kg

Antiretroviral Therapy

Placebo

About this trial

This is an interventional treatment trial for HIV-1-infection focused on measuring ASC22, HIV, PD-L1

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Exclusion Criteria:

Known allergy to the drug or excipients used in this trial.
HIV-associated opportunistic infections in the past 5 years.
Co-sensors of HBV, HCV, syphilis, etc.
With bleeding disorders or on anticoagulant therapy.

Sites / Locations

The FifthMedical Center of the General Hospital of thePeoples Liberation ArmyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

ASC22 1mg/kg

ASC22 2.5mg/kg

Placebo

Arm Description

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

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

0.9% Saline and anti-retroviral therapy for 12 weeks

Outcomes

Primary Outcome Measures

CD4/CD8 ratio changes compared with baseline

Secondary Outcome Measures

HIV-DNA copy changes compared with baselnie

CD4+ count changes compared with baseline

CD8+ count changes compared with baseline

HLA-DR number changes compared with baseline

CD38 count changes compared with baseline

IL-2 concentration changes compared with baseline

Full Information

NCT ID

NCT05330143

First Posted

March 17, 2022

Last Updated

February 21, 2023

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05330143

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 28, 2022 (Actual)

Primary Completion Date

December 6, 2023 (Anticipated)

Study Completion Date

December 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ascletis Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

ASC22, HIV, PD-L1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ASC22 1mg/kg

Arm Type

Experimental

Arm Description

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

Arm Title

ASC22 2.5mg/kg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0.9% Saline and anti-retroviral therapy for 12 weeks

Intervention Type

Drug

Intervention Name(s)

ASC22 1mg/kg

Other Intervention Name(s)

KN035

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ASC22 2.5mg/kg

Other Intervention Name(s)

KN035

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Antiretroviral Therapy

Intervention Description

standard antiretroviral therapy including Integrase inhibitors (INSTIs)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

0.9% saline vials administered subcutaneously once 4 week.

Primary Outcome Measure Information:

Title

CD4/CD8 ratio changes compared with baseline

Time Frame

Week 4\Week 8\Week 12

Secondary Outcome Measure Information:

Title

HIV-DNA copy changes compared with baselnie

Time Frame

Week 12

Title

CD4+ count changes compared with baseline

Time Frame

Week 12

Title

CD8+ count changes compared with baseline

Time Frame

Week 12

Title

HLA-DR number changes compared with baseline

Time Frame

Week 12

Title

CD38 count changes compared with baseline

Time Frame

Week 12

Title

IL-2 concentration changes compared with baseline

Time Frame

Week 4\Week 8\Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. Exclusion Criteria: Known allergy to the drug or excipients used in this trial. HIV-associated opportunistic infections in the past 5 years. Co-sensors of HBV, HCV, syphilis, etc. With bleeding disorders or on anticoagulant therapy.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fusheng Wang, M.D

Phone

86-010-66933114

fswang302@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yuanyuan Li, Doctor

Phone

86-010-66933114

lyy020818@sina.com

Facility Information:

Facility Name

The FifthMedical Center of the General Hospital of thePeoples Liberation Army

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fusheng Wang

Phone

+861066933114

fswang302@163.com

First Name & Middle Initial & Last Name & Degree

Yuanyuan Li

Phone

+861066933114

lyy020818@sina.com

First Name & Middle Initial & Last Name & Degree

Fusheng Wang, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

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