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

NCT06278389 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-03-05

No results posted yet for this study

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).

Conditions

  • Healthy Adult Participants

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.

Sponsors & Collaborators

  • Chengdu Aidea Pharmaceutical Technology Co., Ltd

    collaborator INDUSTRY

  • Jiangsu Aidea Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

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

  • Chaoying Hu, Ph.D. · Beijing Ditan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-24
Primary Completion
2024-04-23
Completion
2024-04-23

Countries

  • China

Study Locations

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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 NCT06278389 on ClinicalTrials.gov