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Phase Ib/IIa Clinical Study of ACC017 Tablets

NCT06719310 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-12-05

No results posted yet for this study

Summary

ACC017 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase Ib/IIa, randomized, double-blind, parallel, dose ranging, placebo-controlled 'proof of concept' study is designed to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of ACC017 monotherapy and combined with FTC/TAF by sequency versus placebo in treatment-naïve HIV-1 infected adults. This study includes two stages, stage one is a single dose escalation, and all subjects will be co-administrated with FTC/TAF at 200 mg/25 mg on stage two. The study consists of a screening visit, baseline period, monotherapy period, and combination therapy period. Total 36 subjects will be randomized in a 5:1 ratio to receive one of three doses of ACC017 or placebo lasting for 10 days for monotherapy followed by 18 days for combination therapy.

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

ACC017+FTC/TAF

ACC017+FTC/TAF

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Chengdu Aidea Pharmaceutical Technology Co., Ltd

    collaborator INDUSTRY

  • Jiangsu Aidea Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhang Fujie, M.D., Ph.D. · Beijing Ditan Hospital

  • Hu C Ying, Ph.D. · Beijing Ditan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-28
Primary Completion
2025-08-31
Completion
2025-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06719310 on ClinicalTrials.gov