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RECRUITING
NCT06719310
PHASE1/PHASE2

Phase Ib/IIa Clinical Study of ACC017 Tablets

Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase Ib/IIa, Randomized, Double Blinded, Perallel, Dosing Ranging, Placebo Controled and Proof of Concept Clinical Trial to Evaluate the Safety, Tolerability, PK and Antiviral Effect of ACC017 Tablet as Monotherapy/Combination With NRTI in Treatment naïve HIV-infected Adults

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-08-28

Completion Date

2025-11

Last Updated

2024-12-05

Healthy Volunteers

No

Interventions

DRUG

ACC017+FTC/TAF

ACC017+FTC/TAF

DRUG

Placebo

Placebo

Locations (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, China