Human Immunodeficiency Virus (HIV) InfectionPhase 1NCT07753902
Bioequivalence Study of ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions
A Phase 1 study testing ACC118-Test and Reference in people with Human Immunodeficiency Virus (HIV) Infection, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV) Infection
- What is being tested?
- ACC118-Test and Reference
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 12 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- Subjects with difficulty in blood collection or a history of needle phobia or vasovagal syncope associated with blood draws.
- Subjects who are unable to complete the trial due to other reasons, or who are deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Open-Label, Three-Sequence, Three-Period, Partially Replicated Bioequivalence Study of Single-Dose ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions.
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?
Read more
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.
- Being tested
- ACC118-Test, Reference
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACC118-TestDrug
Also called ADC118 Tablets (ACC017/Emtricitabine/Tenofovir Alafenamide Fumarate Combination Tablet)
Single oral dose of ADC118 tablet, strength: 35 mg ACC017 / 200 mg emtricitabine / 25 mg tenofovir alafenamide fumarate per tablet.
ReferenceDrug
Also called ACC017 Tablets Co-administered with Emtricitabine/Tenofovir Alafenamide Fumarate Tablets (II)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: ACC118-Test; Drug: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
Secondary outcomes (28)
PK Parameter: Tmax
Tmax is defined as the time to reach the maximum observed plasma concentration (Cmax)
Measured: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
PK Parameter: AUC0-24h
AUC0-24h is defined as the area under the plasma concentration-time curve from time zero to 24 hours post-dose.
Measured: Day 1 (pre-dose) through Day 2 (24 hours post-dose) of each treatment period
PK Parameter: C24h
C24h is defined as the plasma drug concentration sampled at 24 hours post-dose.
Measured: 24 hours post-dose on Day 2 of each treatment period
PK Parameter: AUC_%Extrap
AUC_%Extrap is defined as the percentage of AUC0-∞ that is due to extrapolation from the time of the last measurable concentration (Tlast) to infinity, calculated as [(AUC0-∞ - AUC0-t) / AUC0-∞] × 100%.
Measured: Day 1 through Day 6 of each treatment period
PK Parameter: t1/2
t1/2 is defined as the plasma elimination half-life, calculated as ln(2)/λz. λz is the terminal elimination rate constant, determined by linear regression of the log-transformed plasma concentration versus time curve; the negative value of the slope represents λz.
Measured: Day 1 through Day 6 of each treatment period
Safety: Adverse Events
Frequency, causality, severity, and expectedness of treatment-emergent adverse events (TEAEs), including Adverse Drug Reactions (ADRs), Grade ≥3 AEs, Serious Adverse Events (SAEs), Serious Adverse Drug Reactions (SADRs), and AEs leading to treatment discontinuation or early withdrawal from the trial.
Measured: From signing of informed consent through study completion, up to approximately 10 weeks
Vital sign: Systolic blood pressure and diastolic blood pressure
Changes from baseline in systolic blood pressure and diastolic blood pressure.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Vital sign: Heart rate
Changes from baseline in heart rate.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Vital sign: Respiratory rate
Changes from baseline in respiratory rate.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Vital sign: Oral body temperature
Changes from baseline in oral body temperature.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:skin
Clinically significant changes from baseline in skin examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination: general appearance
Clinically significant changes from baseline in general appearance examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:head
Clinically significant changes from baseline in head examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:eyes
Clinically significant changes from baseline in eyes examination, categorized as medical history, AE, or other
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination: ears
Clinically significant changes from baseline in ears examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:oral
Clinically significant changes from baseline oral appearance examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:throat
Clinically significant changes from baseline in throat examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:neck
Clinically significant changes from baseline in neck examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:heart
Clinically significant changes from baseline in heart examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:lungs
Clinically significant changes from baseline in lungs examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination: extremities
Clinically significant changes from baseline in extremities examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination: neuromuscular
Clinically significant changes from baseline in neuromuscular examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination: abdomen
Clinically significant changes from baseline in abdomen examination, categorized as medical history, AE, or other.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Clinical laboratory tests: Hematology
Number of participants with clinically significant changes from baseline in hematology parameters. Parameters assessed include white blood cell count, red blood cell count, hemoglobin, hematocrit, platelet count, and differential counts (e.g., neutrophils, lymphocytes, monocytes, eosinophils, basophils).
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Clinical laboratory tests: Blood biochemistry
Number of participants with clinically significant changes from baseline in blood biochemistry parameters. Parameters assessed include ALT, AST, alkaline phosphatase, total bilirubin, direct bilirubin, GGT, LDH, glucose, total protein, albumin, urea, creatinine, potassium, sodium, amylase, and lipase.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Clinical laboratory tests: Urinalysis
Number of participants with clinically significant changes from baseline in urinalysis parameters. Parameters assessed include white blood cells, red blood cells, pH, protein, glucose, and ketones.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Clinical laboratory tests: Coagulation function tests
Number of participants with clinically significant changes from baseline in coagulation function tests. Parameters assessed include prothrombin time, activated partial thromboplastin time, and international normalized ratio (INR).
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
12-Lead Electrocardiogram (ECG)
Changes from baseline in 12-lead ECG parameters, including heart rate, PR interval, QRS duration, QT interval, and QTcF interval.
Measured: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start10 Apr 2026
- Primary completion18 May 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753902
- Sponsor's protocol ID
- ADYY-ADC118-101
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Open-Label, Three-Sequence, Three-Period, Partially Replicated Bioequivalence Study of Single-Dose ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT07753902
- Acronym / sponsor ID
- ADYY-ADC118-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test-Reference-Reference Sequence | Experimental | Drug: ACC118-Test, Drug: ReferenceParticipants 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. |
| Reference-Test-Reference Sequence | Experimental | Drug: ACC118-Test, Drug: ReferenceParticipants 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. |
| Reference-Reference-Test Sequence | Experimental | Drug: ACC118-Test, Drug: ReferenceParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACC118-TestAlso: ADC118 Tablets (ACC017/Emtricitabine/Tenofovir Alafenamide Fumarate Combination Tablet)Single oral dose of ADC118 tablet, strength: 35 mg ACC017 / 200 mg emtricitabine / 25 mg tenofovir alafenamide fumarate per tablet. | Drug | Reference-Reference-Test Sequence, Reference-Test-Reference Sequence, Test-Reference-Reference Sequence |
| ReferenceAlso: ACC017 Tablets Co-administered with Emtricitabine/Tenofovir Alafenamide Fumarate Tablets (II)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. | Drug | Reference-Reference-Test Sequence, Reference-Test-Reference Sequence, Test-Reference-Reference Sequence |
Primary outcome
PK Parameter: Cmax
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
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.
PK Parameter: AUC0-t
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
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.
PK Parameter: AUC0-∞
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
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.
28 secondary outcomes
PK Parameter: Tmax
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
PK Parameter: AUC0-24h
Time frame: Day 1 (pre-dose) through Day 2 (24 hours post-dose) of each treatment period
PK Parameter: C24h
Time frame: 24 hours post-dose on Day 2 of each treatment period
PK Parameter: AUC_%Extrap
Time frame: Day 1 through Day 6 of each treatment period
PK Parameter: t1/2
Time frame: Day 1 through Day 6 of each treatment period
Safety: Adverse Events
Time frame: From signing of informed consent through study completion, up to approximately 10 weeks
Vital sign: Systolic blood pressure and diastolic blood pressure
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Vital sign: Heart rate
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Vital sign: Respiratory rate
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Vital sign: Oral body temperature
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:skin
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination: general appearance
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:head
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:eyes
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination: ears
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:oral
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:throat
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:neck
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:heart
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination:lungs
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination: extremities
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination: neuromuscular
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Physical examination: abdomen
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Clinical laboratory tests: Hematology
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Clinical laboratory tests: Blood biochemistry
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Clinical laboratory tests: Urinalysis
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Clinical laboratory tests: Coagulation function tests
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
12-Lead Electrocardiogram (ECG)
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACC118-Test and Reference in people with Human Immunodeficiency Virus (HIV) Infection, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK Parameter: Cmax (time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.