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

NCT05330143 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-11-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ascletis Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2024-05-15
Completion
2024-05-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05330143 on ClinicalTrials.gov