Healthy Adult Participants Clinical Trial
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
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).
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD), two-stage, phase Ia clinical trial in Chinese healthy adults to evaluate the safety, tolerability, PK, FE, and DDIs with FTC/TAF of ACC017 tablets administered as a single dose in healthy participants. The trial will be divided into two stages: the first stage is a single-center, randomized, double-blind, placebo-controlled SAD study. The study consists of six dose cohorts, namely, 5 mg, 20 mg, 40 mg, 80 mg, 120 mg, and 160 mg cohorts (whether to escalate to the 160 mg cohort will be determined or adjusted if applicable) (D2~D7), and a subsequent discharge visit (D8). Participants will receive a single oral dose of ACC017 tablets or placebo under fasting conditions. The second stage is a single-center, randomized, open-label FE and DDI study with a tentative dose of 40 mg. The final administered dose will be determined after completion of the SAD study, as assessed by the investigator and the sponsor. Stage 2 is planned to enroll 12 healthy participants (both males and females), who are randomly assigned at a 1:1 ratio to either the fasting-postprandial group (F-P group) or the postprandial-fasting group (P-F group), with 6 participants in each group. Eligible healthy participants are admitted on D-1 and receive a single oral dose of ACC017 tablets on the day of administration of each cycle under the fasting or postprandial condition, with a washout period of 7 days during the two-week period. After completing the second cycle of drug washout, participants are evaluated by the investigator and enter into the DDI study and receive a single oral dose of ACC017 tablets with FTC/TAF tablets under fasting condition. The study is divided into screening period (no more than 28 days, D-28 to D-1), FE first cycle (D1), washout period A (D2 to D7), FE second cycle (D8), washout period B (D9 to D14), DDI period (D15), wahout period C (D16 to D21), and discharge (D22) visits. ;
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