A Phase 1 interventional study of ACC118-Test and Reference in Human Immunodeficiency Virus (HIV) Infection, sponsored by Jiangsu Aidea Pharmaceutical Group Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Jiangsu Aidea Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Other
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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.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
This study's enrollment of 48 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Jiangsu Aidea Pharmaceutical Group Co., Ltd. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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)
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
PK Parameter: Tmax
Tmax is defined as the time to reach the maximum observed plasma concentration (Cmax)
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Changes from baseline in 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
Changes from baseline in 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
Changes from baseline in 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
Clinically significant changes from baseline in skin examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline in general appearance examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline in head examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline in eyes examination, categorized as medical history, AE, or other
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
Clinically significant changes from baseline in ears examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline oral appearance examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline in throat examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline in neck examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline in heart examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline in lungs examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline in extremities examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline in neuromuscular examination, categorized as medical history, AE, or other.
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
Clinically significant changes from baseline in abdomen examination, categorized as medical history, AE, or other.
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
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).
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
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.
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
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.
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
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).
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)
Changes from baseline in 12-lead ECG parameters, including heart rate, PR interval, QRS duration, QT interval, and QTcF interval.
Time frame: From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose)
Ran from Apr 2026 to primary completion in May 2026, 1 month.
Of 76 industry-sponsored phase 1 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 18. This study's 1 month is below that.
Counting every sponsor, half of 139 studies reached it within 14 months; a quarter within 4 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Jiangsu Aidea Pharmaceutical Group Co., Ltd. →