protocolSection identificationModule nctId: NCT06278389, orgStudyIdInfo id: ADYY-ACC017-101, secondaryIdInfos id: CTR20240167, type: REGISTRY, domain: chinadrugtrials.org.cn, briefTitle: Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-24, primaryCompletionDateStruct date: 2024-04-23, completionDateStruct date: 2024-04-23, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Jiangsu Aidea Pharmaceutical Co., Ltd, class: INDUSTRY, collaborators name: Chengdu Aidea Pharmaceutical Technology Co., Ltd, descriptionModule briefSummary: 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)., conditionsModule conditions: Healthy Adult Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: ACC017 tablets, interventions name: Emtricitabine and Tenofovir Alafenamide Fumarate Tablets, outcomesModule primaryOutcomes measure: Frequency, causality, severity, and expectedness of adverse events (AEs), primaryOutcomes measure: ACC017 PK parameter: Cmax (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: C24h (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: AUC0-t (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: AUC0-∞ (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: Tmax (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: t1/2 (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: Vz/F (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: CL/F (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: λz (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: AUC_%Extrap (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: MRT0-t (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: MRT0-∞ (after a single mono-drug administration under the fasting condition), secondaryOutcomes measure: Vital signs: temperature, secondaryOutcomes measure: Vital sign: pulse, secondaryOutcomes measure: Vital signs: blood pressure, secondaryOutcomes measure: Vital signs: respiration, secondaryOutcomes measure: Electrocardiogram (ECG): heart rate, secondaryOutcomes measure: Electrocardiogram (ECG): PR interval, secondaryOutcomes measure: Electrocardiogram (ECG): QRS duration, secondaryOutcomes measure: Electrocardiogram (ECG): QTc interval, secondaryOutcomes measure: ACC017 PK parameter: Cmax, secondaryOutcomes measure: ACC017 PK parameter: C24h, secondaryOutcomes measure: ACC017 PK parameter: AUC0-t, secondaryOutcomes measure: ACC017 PK parameter: AUC0-∞, secondaryOutcomes measure: ACC017 PK parameter: Tmax, secondaryOutcomes measure: ACC017 PK parameter: t1/2, secondaryOutcomes measure: ACC017 PK parameter: Vz/F, secondaryOutcomes measure: ACC017 PK parameter: CL/F, secondaryOutcomes measure: ACC017 PK parameter: λz, secondaryOutcomes measure: ACC017 PK parameter: AUC_%Extrap, secondaryOutcomes measure: ACC017 PK parameter: MRT0-t, secondaryOutcomes measure: ACC017 PK parameter: MRT0-∞, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Ditan Hospital Capital Medical University, status: RECRUITING, city: Beijing, zip: 100015, country: China, contacts name: Fujie Zhang, role: CONTACT, email: treatment@chinaaids.cn, contacts name: Chaoying Hu, role: CONTACT, email: hucarol@126.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False