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drugset / Trial / NCT06278389

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

NCT06278389 ↗

Phase 1 Unknown 52 enrolled Jiangsu Aidea Pharmaceutical Group Co., Ltd. Chengdu Aidea Pharmaceutical Technology Co., Ltd · collab
RandomizedSequentialTriple-blindTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject ACC017 Unknown 5 mg Oral
Subject ACC017 Unknown 20 mg Oral
Subject ACC017 Unknown 40 mg Oral
Subject ACC017 Unknown 80 mg Oral
Subject ACC017 Unknown 120 mg Oral
Subject ACC017 Unknown 160 mg Oral
Subject emtricitabine Other / unclassified — Oral
Subject tenofovir alafenamide Small molecule — Oral

Indications

No indication recorded.