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COMPLETED
NCT06278389
PHASE1

Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants

Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

The objective of this clinical trial is to investigate the safety and tolerability of single ascending dose ACC017 tablets in Chinese healthy adult participants. This study aims to address the following major questions: * Recommended dosage for ACC017 tablets used in phase Ib/IIa trial; * The pharmacokinetic (PK) characteristics of single dose ACC017 tablets; * The effect of food (FE) on the PK of ACC017 tablets; * Drug-drug interactions (DDIs) when ACC017 tablets are co-administered with emtricitabine and tenofovir alafenamide fumarate (FTC/TAF) tablets (II).

Official title: Study of Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants in China: A Single-center, Randomized, Double-blind, Placebo-controlled, Two-Stage Trial

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-01-24

Completion Date

2024-05-20

Last Updated

2026-08-14

Healthy Volunteers

Yes

Interventions

DRUG

ACC017 tablets

ACC017 tablets 5 mg, 20 mg, 40 mg, 80 mg, 120 mg, and 160 mg (tentative) with matching placebo

DRUG

Emtricitabine and Tenofovir Alafenamide Fumarate Tablets

Participants received a single oral dose of ACC017 tablets with emtricitabine and tenofovir alafenamide fumarate tablets under the fasting condition.

Locations (1)

Beijing Ditan Hospital Capital Medical University

Beijing, China