Bioequivalence Study of ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions

NCT07753902 | Completed Phase 1

• 1 other identifier: ADYY-ADC118-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the bioequivalence of a single oral dose of the test drug ADC118 tablets compared with the reference drugs (ACC017 tablets and emtricitabine/tenofovir alafenamide fumarate tablets \[II\]) under fasting conditions in healthy adult Chinese participants. It will also assess the safety of the test drug. The main questions it aims to answer include: Is the rate and extent of absorption of the test drug ADC118 tablets equivalent to that of the reference drugs? What adverse events will participants experience while taking the study drugs? Researchers will compare the pharmacokinetic profiles of ADC118 tablets with those of the two reference drugs after a single dose. Participants will: Be randomly assigned to one of three treatment sequences (TRR, RTR, or RRT) In each of the three periods, after an overnight fast of at least 10 hours, take a single dose of the test drug (T) or the reference drug (R) with 240 mL of warm water Refrain from drinking water (except for the 240 mL taken with the drug) for 1 hour before and after dosing, and not eat any food for 4 hours after dosing Complete blood sample collection and safety assessments according to the protocol This study plans to enroll 48 healthy participants. It is a single-center, randomized, open-label, three-period crossover trial.

Conditions

Human Immunodeficiency Virus (HIV) Infection

Outcome Measures

Primary Outcomes (3)

• PK Parameter: Cmax

  Cmax is defined as the maximum observed plasma concentration of the drug, obtained directly from the concentration-time data, following a single oral dose of the test or reference product under fasting conditions.

  Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period

• PK Parameter: AUC0-t

  AUC0-t is defined as the area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule.

  Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period

• PK Parameter: AUC0-∞

  AUC0-∞ is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity, calculated as AUC0-t + Clast/λz, where Clast is the last measurable plasma concentration and λz is the terminal elimination rate constant.

  Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period

Secondary Outcomes (28)

• PK Parameter: Tmax

  Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period

• PK Parameter: AUC0-24h

  Day 1 (pre-dose) through Day 2 (24 hours post-dose) of each treatment period

• PK Parameter: C24h

  24 hours post-dose on Day 2 of each treatment period

• PK Parameter: AUC_%Extrap

  Day 1 through Day 6 of each treatment period

• PK Parameter: t1/2

  Day 1 through Day 6 of each treatment period

Study Arms (3)

Test-Reference-Reference Sequence

EXPERIMENTAL

Participants assigned to this arm will receive a single oral dose of the test product (T: ADC118 tablets) in Period 1, followed by a single oral dose of the reference products (R: ACC017 tablets co-administered with emtricitabine/tenofovir alafenamide fumarate tablets \[II\]) in Period 2, and again the reference products (R) in Period 3. All doses are administered under fasting conditions after an overnight fast of at least 10 hours, with 240 mL of warm water. A washout period separates each treatment period.

Drug: ACC118-Test; Drug: Reference

Reference-Test-Reference Sequence

EXPERIMENTAL

Participants assigned to this arm will receive a single oral dose of the reference products (R: ACC017 tablets co-administered with emtricitabine/tenofovir alafenamide fumarate tablets \[II\]) in Period 1, followed by a single oral dose of the test product (T: ADC118 tablets) in Period 2, and then the reference products (R) again in Period 3. All doses are administered under fasting conditions after an overnight fast of at least 10 hours, with 240 mL of warm water. A washout period separates each treatment period.

Drug: ACC118-Test; Drug: Reference

Reference-Reference-Test Sequence

EXPERIMENTAL

Participants assigned to this arm will receive a single oral dose of the reference products (R: ACC017 tablets co-administered with emtricitabine/tenofovir alafenamide fumarate tablets \[II\]) in Period 1, again the reference products (R) in Period 2, followed by a single oral dose of the test product (T: ADC118 tablets) in Period 3. All doses are administered under fasting conditions after an overnight fast of at least 10 hours, with 240 mL of warm water. A washout period separates each treatment period.

Drug: ACC118-Test; Drug: Reference

Interventions

Reference DRUG

Single oral dose of the following tablets taken together: Two tablets of ACC017, strength: 20 mg/tablet. One tablet of Emtricitabine/Tenofovir Alafenamide Fumarate Tablets (II), strength: 200 mg emtricitabine / 25 mg tenofovir alafenamide fumarate per tablet.

Also known as: ACC017 Tablets Co-administered with Emtricitabine/Tenofovir Alafenamide Fumarate Tablets (II)

Reference-Reference-Test Sequence; Reference-Test-Reference Sequence; Test-Reference-Reference Sequence

ACC118-Test DRUG

Single oral dose of ADC118 tablet, strength: 35 mg ACC017 / 200 mg emtricitabine / 25 mg tenofovir alafenamide fumarate per tablet.

Also known as: ADC118 Tablets (ACC017/Emtricitabine/Tenofovir Alafenamide Fumarate Combination Tablet)

Reference-Reference-Test Sequence; Reference-Test-Reference Sequence; Test-Reference-Reference Sequence

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males and non-pregnant, non-lactating healthy adult females, aged 18 to 55 years (inclusive) at the time of signing the informed consent form. Subjects who exceed 55 years of age during the trial will not be excluded.
• Weight: males ≥ 50.0 kg, females ≥ 45.0 kg; body mass index (BMI) \[BMI = weight (kg)/height² (m²)\] between 19.0 and 26.0 kg/m² (inclusive).
• Participants (including their partners) are willing to have no pregnancy plan from the screening period until 6 months after the end of the trial, voluntarily use effective contraceptive measures, and have no plans for childbearing or sperm/egg donation.
• Fully understand the content of the informed consent form, voluntarily sign it, and voluntarily participate in the trial.
• Able to complete the study according to the requirements of the trial protocol.

You may not qualify if:

• Subjects with a history of allergy (allergic to two or more drugs or foods), or known allergy to the investigational product or its excipients.
• Subjects with any history of clinically significant disease, or history of cardiovascular, endocrine, neurological, digestive system diseases, or pulmonary, hematological, immunological, psychiatric diseases, and metabolic abnormalities.
• Subjects who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the trial, and those who have undergone any surgery that could affect the absorption, distribution, metabolism, or excretion of the drug.
• Subjects with abnormalities in physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory tests that are deemed clinically significant by the investigator.
• Female participants who are lactating or have a positive pregnancy test during the screening period or during the trial.
• Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis screening.
• Subjects who have taken any other investigational drug or participated in any other medical or drug clinical trial within 3 months prior to screening.
• Subjects who have received any vaccination within 1 month prior to screening.
• Subjects who have donated more than 400 mL of blood or experienced significant blood loss (\>400 mL) within 3 months prior to screening, or who plan to donate blood during the trial or within one month after the end of the trial.
• Subjects who have a smoking habit (average of ≥5 cigarettes per day) within 3 months prior to screening, or who are unable to abstain from using any tobacco products during the trial.
• Subjects who have consumed more than 14 units of alcohol per week within 6 months prior to screening (1 unit of alcohol = 360 mL of beer, or 45 mL of spirits with 40% alcohol, or 150 mL of wine), or who are unable to abstain from alcohol during the trial, or who have a positive alcohol screening test.
• Subjects with a positive drug abuse screening test, or a history of drug abuse, or who have used illicit drugs within 3 months prior to screening.
• Subjects who have taken any prescription drugs, over-the-counter medications, health supplements, or herbal medicines within 14 days prior to screening.
• Subjects who develop any new illness or use any new medication (including prescription drugs, over-the-counter medications, health supplements, or herbal medicines) during the period from screening to admission on Day -1.
• Subjects with special dietary requirements who are unable to comply with the standardized diet.

Sponsors & Collaborators

• Jiangsu Aidea Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Chizhou People's Hospital

Chizhou, Anhui, 247100, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-center, randomized, open-label, three-sequence, three-period, partially-replicated crossover study. Eligible participants will be randomly assigned to one of three treatment sequences: TRR, RTR, or RRT. In each period, participants will receive a single oral dose of either the test product (T: ADC118 tablets) or the reference products (R: ACC017 tablets and emtricitabine/tenofovir alafenamide fumarate tablets \[II\]) under fasting conditions, with a washout interval separating each period. All participants will receive both the test and reference interventions in a crossover manner across the three periods, with each participant receiving the test product once and the reference products twice, depending on the assigned sequence.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 10, 2026
• Study Start: April 10, 2026
• Primary Completion: May 18, 2026
• Study Completion: June 12, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-07

Locations

CN (1)