Healthy Adult ParticipantsPhase 1NCT06278389
Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants
A Phase 1 study testing ACC017 tablets and Emtricitabine and Tenofovir Alafenamide Fumarate Tablets in people with Healthy Adult Participants, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- ACC017 tablets and Emtricitabine and Tenofovir Alafenamide Fumarate Tablets
- 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
- 24 Jan 2024to 20 May 2024
- 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
- Volunteering to sign the informed consent and able to follow protocol-defined procedural requirements;
- Aged 18 to 55 years (inclusive);
- Male weighing ≥ 50.0 kg, female weighing ≥ 45.0 kg, and body mass index (BMI) = weight(kg)/height^2 (m^2) within the range of 18.5~26 kg/m^2 (inclusive);
- Women of child-bearing potential (WOCBP) or men without a birth plan (including sperm or egg donation) and agreeing to use effective contraception (including one or more non-pharmacological contraceptives or non-heterosexual sexual activity in daily life) from 1 month prior to informed consent up to 3 months after the last dose of the study medication;
- No history of significant medical or surgical illness, and normal results on vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, chest X-ray and abdominal ultrasound examination during the screening period, or minor deviations from normal reference values that are not clinically significant in the judgment of the investigator.
Who cannot join
- Occurrence or persistence of clinically significant abnormal conditions, including but not limited to cardiovascular, respiratory, gastrointestinal (any history of gastrointestinal disorders affecting the absorption of medications), urinary, hematologic and lymphatic, endocrine, musculoskeletal, immune, and neuropsychiatric disorders;
- Possible or definite allergic reaction to the study drug, placebo, or any of the excipients contained, as judged by the investigator, or allergy (multiple drug and food sensitivities), or a history of allergic disease (e.g., asthma, urticaria, and eczematous dermatitis, etc.);
- Acute illness, such as respiratory tract infections requiring antibiotic treatment, occurring from screening until study drug administration;
- Inability to tolerate venipuncture, or history of needle-sickness or blood-sickness, or blood donation including component blood or significant blood loss (≥400 mL) or receipt of blood transfusion within 3 months prior to screening, or planning to donate blood during the trial period;
- Dysphagia, or surgery within 6 months prior to screening, or surgery planned during the trial, or surgery that interferes with the absorption, distribution, metabolism, or excretion of the medication;
- Smoking an average of >5 cigarettes per day within 3 months prior to screening, or inability to stop using any tobacco-based product during the trial period;
Show all 19Show fewer
- Average weekly alcohol consumption greater than 14 units (1 unit of alcohol ≈ 360 mL of beer, or 45 mL of 40% (alcohol by volume) spirits, or 150 mL of wine) within 3 months prior to screening or inability to discontinue use of any alcohol-containing product during the trial period, or with a positive breath test for alcohol at screening;
- Excessive consumption of tea, coffee, and/or caffeinated beverages (more than 8 cups on average per day, 1 cup ≈ 250 mL) within 3 months prior to screening, or inability to stop consuming tea, coffee, and/or caffeinated beverages during the trial period;
- Consumption or drinking of dragon fruit, mango, grapefruit, popcorn, or foods or beverages prepared from the aforementioned fruits, or foods or beverages containing xanthines, caffeine, or alcohol (including chocolate, tea, coffee, cola, and cocoa), or any other special diet that interferes with the absorption, distribution, metabolism, or excretion of the drug, within 48 hours prior to administration of the study medication;
- With special dietary requirements, or cannot accept a uniform diet；
- Use of strong or moderate CYP3A inhibitors (e.g., clarithromycin, telithromycin, ketoconazole, itraconazole and nefazodone, etc.) or strong CYP3A4 inducers (e.g., rifampicin, efavirenz, carbamazepine, phenobarbital, phenytoin, pioglitazone, St. John's wort, and glucocorticoids, etc.) within 28 days or 5 half-lives (whichever is longer) before screening；
- Use of strong or moderate UGT1A inhibitors (e.g., silybin, ritonavir, atazanavir, quinidine, diclofenac, mycophenolic acid, and osimertinib, etc.) or strong UGT1A1 inducers (e.g., rifampicin, carbamazepine, phenobarbital, and phenytoin, etc.) within 28 days or 5 drug half-lives (whichever is longer) before screening;
- Use of any prescription drugs, over-the-counter drugs or Chinese (herbal) medicines within 14 days or 5 drug half-lives (whichever is longer) prior to screening；
- Vaccination (e.g., SARS-CoV-2 virus vaccine, and hepatitis B virus vaccine, etc.) within 1 month before screening, and are not suitable for enrollment as assessed by the investigator；
- Positive for hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody, or Tponema pallidum (Tp) antibody at screening；
- History of substance abuse within 5 years prior to screening, or positive urine drug screen at screening；
- Females who are pregnant or lactating at the time of screening, or have a positive blood pregnancy test (for WOCBP only)；
- Participation in any interventional clinical trials, including drugs, vaccines, or devices, etc., within 3 months prior to screening,；
- It is not suitable for a participant to participate in this trial in the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
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.
- Conditions
- Healthy Adult Participants
- Being tested
- ACC017 tablets, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACC017 tabletsDrug
Also called ACC017/Placebo
ACC017 tablets 5 mg, 20 mg, 40 mg, 80 mg, 120 mg, and 160 mg (tentative) with matching placebo
Emtricitabine and Tenofovir Alafenamide Fumarate TabletsDrug
Also called Descovy
Participants received a single oral dose of ACC017 tablets with emtricitabine and tenofovir alafenamide fumarate tablets under the fasting condition.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: ACC017 and placebo | Experimental | The trial is conducted sequentially from the low-dose cohorts, namely, 5 mg, 20 mg, 40 mg, 80 mg, 120 mg and 160 mg（tentative), respectively. Participants are given a single dose of ACC017 tablets or placebo under the fasting condition. Receives: Drug: ACC017 tablets |
| Stage 2: ACC017 and FTC/TAF (Descovy） | Experimental | Stage 2 is a single center, randomized, open-label FE and DDI study with a tentative dose of 40 mg. The stage was planned to enroll 12 healthy participants (both male and female) who are randomly assigned to either the fasting-postprandial or postprandial-fasting arm at a 1:1 ratio. Eligible healthy participants are admitted on D-1 and received 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 washout of the second cycle, participants are assessed by the investigator to enter into the DDI study and receive a single oral dose of ACC017 tablets with FTC/TAF tablets under the fasting condition. Receives: Drug: ACC017 tablets; Drug: Emtricitabine and Tenofovir Alafenamide Fumarate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, causality, severity, and expectedness of adverse events (AEs)
Includes Adverse Drug Reactions [ADRs], Grade 3 and above AEs, and Serious Adverse Events [SAEs], Serious Adverse Drug Reactions [SADRs], AEs resulting in treatment interruptions, AEs resulting in early withdrawal from the trial, and AEs of Special Interest [AESI]
Measured: Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: Cmax (after a single mono-drug administration under the fasting condition)
Cmax is defined as the maximum observed concentration of drug
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: C24h (after a single mono-drug administration under the fasting condition)
C24h is defined as the plasma drug concentrations sampled 24 hours-post dose (C24h)
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: AUC0-t (after a single mono-drug administration under the fasting condition)
AUC0-t is defined as area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: AUC0-∞ (after a single mono-drug administration under the fasting condition)
AUC0-∞ is defined as AUC from time zero to infinity
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: Tmax (after a single mono-drug administration under the fasting condition)
Tmax is defined as the time to reach Cmax
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: t1/2 (after a single mono-drug administration under the fasting condition)
Half-life
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: Vz/F (after a single mono-drug administration under the fasting condition)
Apparent volume of distribution during terminal phase after oral administration
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: CL/F (after a single mono-drug administration under the fasting condition)
Apparent total plasma clearance of drug after oral administration
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: λz (after a single mono-drug administration under the fasting condition)
Terminal elimination rate constant
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: AUC_%Extrap (after a single mono-drug administration under the fasting condition)
Percentage of AUCinf due to extrapolation from Tlast to infinity
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: MRT0-t (after a single mono-drug administration under the fasting condition)
MRT0-t is defined as the mean retention time from time zero to the time of the last measurable plasma concentration
Measured: Day 1 through Day 8 of Stage 1
ACC017 PK parameter: MRT0-∞ (after a single mono-drug administration under the fasting condition)
MRT0-∞ is defined as MRT from time zero to infinity
Measured: Day 1 through Day 8 of Stage 1
Secondary outcomes (20)
Vital signs: temperature
Temperature in degree Celsius
Measured: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Vital sign: pulse
Pulse in beat per minute
Measured: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Vital signs: blood pressure
Systolic and diastolic blood pressure in millimeters (mm) of mercury (Hg)
Measured: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Vital signs: respiration
Respiratory rate in breaths per minute
Measured: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Electrocardiogram (ECG): heart rate
Heart rate in beat per minute
Measured: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Electrocardiogram (ECG): PR interval
Changes in PR interval
Measured: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Electrocardiogram (ECG): QRS duration
Changes in QRS duration
Measured: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Electrocardiogram (ECG): QTc interval
Changes in QTc interval
Measured: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: Cmax
ACC017 Cmax after single postprandial single-drug administration，ACC017 Cmax after a single coadministration under the fasting condition and FTC and TAF Cmax after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: C24h
ACC017 C24h after single postprandial single-drug administration，ACC017 C24h after a single coadministration under the fasting condition and FTC and TAF C24h after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: AUC0-t
ACC017 AUC0-t after single postprandial single-drug administration，ACC017 AUC0-t after a single coadministration under the fasting condition and FTC and TAF AUC0-t after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: AUC0-∞
ACC017 AUC0-∞ after single postprandial single-drug administration，ACC017 AUC0-∞ after a single coadministration under the fasting condition and FTC and TAF AUC0-∞ after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: Tmax
ACC017 Tmax after single postprandial single-drug administration，ACC017 Tmax after a single coadministration under the fasting condition and FTC and TAF Tmax after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: t1/2
ACC017 t1/2 after single postprandial single-drug administration，ACC017 t1/2 after a single coadministration under the fasting condition and FTC and TAF t1/2 after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: Vz/F
ACC017 Vz/F after single postprandial single-drug administration，ACC017 Vz/F after a single coadministration under the fasting condition and FTC and TAF Vz/F after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: CL/F
ACC017 CL/F after single postprandial single-drug administration，ACC017 CL/F after a single coadministration under the fasting condition and FTC and TAF CL/F after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: λz
ACC017 λz after single postprandial single-drug administration，ACC017 λz after a single coadministration under the fasting condition and FTC and TAF λz after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: AUC_%Extrap
ACC017 AUC_%Extrap after single postprandial single-drug administration，ACC017 AUC_%Extrap after a single coadministration under the fasting condition and FTC and TAF AUC_%Extrap after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: MRT0-t
ACC017 MRT0-t after single postprandial single-drug administration，ACC017 MRT0-t after a single coadministration under the fasting condition and FTC and TAF MRT0-t after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: MRT0-∞
ACC017 MRT0-∞ after single postprandial single-drug administration，ACC017 MRT0-∞ after a single coadministration under the fasting condition and FTC and TAF MRT0-∞ after a single coadministration under the fasting condition
Measured: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start24 Jan 2024
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Aidea Pharmaceutical Technology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Fujie Zhang, M.D., Ph.D., Principal investigator, Beijing Ditan HospitalChaoying Hu, Ph.D., Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278389
- Sponsor's protocol ID
- ADYY-ACC017-101
- Other IDs
- CTR20240167
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06278389
- Acronym / sponsor ID
- ADYY-ACC017-101
- Conditions
- Healthy Adult Participants
- 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)
- Collaborators
- Chengdu Aidea Pharmaceutical Technology Co., Ltd
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 26 Feb 2024 (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.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1: ACC017 and placebo | Experimental | Drug: ACC017 tabletsThe trial is conducted sequentially from the low-dose cohorts, namely, 5 mg, 20 mg, 40 mg, 80 mg, 120 mg and 160 mg（tentative), respectively. Participants are given a single dose of ACC017 tablets or placebo under the fasting condition. |
| Stage 2: ACC017 and FTC/TAF (Descovy） | Experimental | Drug: ACC017 tablets, Drug: Emtricitabine and Tenofovir Alafenamide Fumarate TabletsStage 2 is a single center, randomized, open-label FE and DDI study with a tentative dose of 40 mg. The stage was planned to enroll 12 healthy participants (both male and female) who are randomly assigned to either the fasting-postprandial or postprandial-fasting arm at a 1:1 ratio. Eligible healthy participants are admitted on D-1 and received 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 washout of the second cycle, participants are assessed by the investigator to enter into the DDI study and receive a single oral dose of ACC017 tablets with FTC/TAF tablets under the fasting condition. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteering to sign the informed consent and able to follow protocol-defined procedural requirements;
- Aged 18 to 55 years (inclusive);
- Male weighing ≥ 50.0 kg, female weighing ≥ 45.0 kg, and body mass index (BMI) = weight(kg)/height^2 (m^2) within the range of 18.5~26 kg/m^2 (inclusive);
- Women of child-bearing potential (WOCBP) or men without a birth plan (including sperm or egg donation) and agreeing to use effective contraception (including one or more non-pharmacological contraceptives or non-heterosexual sexual activity in daily life) from 1 month prior to informed consent up to 3 months after the last dose of the study medication;
- No history of significant medical or surgical illness, and normal results on vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, chest X-ray and abdominal ultrasound examination during the screening period, or minor deviations from normal reference values that are not clinically significant in the judgment of the investigator.
Key exclusion criteria (19 listed)
- Occurrence or persistence of clinically significant abnormal conditions, including but not limited to cardiovascular, respiratory, gastrointestinal (any history of gastrointestinal disorders affecting the absorption of medications), urinary, hematologic and lymphatic, endocrine, musculoskeletal, immune, and neuropsychiatric disorders;
- Possible or definite allergic reaction to the study drug, placebo, or any of the excipients contained, as judged by the investigator, or allergy (multiple drug and food sensitivities), or a history of allergic disease (e.g., asthma, urticaria, and eczematous dermatitis, etc.);
- Acute illness, such as respiratory tract infections requiring antibiotic treatment, occurring from screening until study drug administration;
- Inability to tolerate venipuncture, or history of needle-sickness or blood-sickness, or blood donation including component blood or significant blood loss (≥400 mL) or receipt of blood transfusion within 3 months prior to screening, or planning to donate blood during the trial period;
- Dysphagia, or surgery within 6 months prior to screening, or surgery planned during the trial, or surgery that interferes with the absorption, distribution, metabolism, or excretion of the medication;
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 |
|---|---|---|
| ACC017 tabletsAlso: ACC017/PlaceboACC017 tablets 5 mg, 20 mg, 40 mg, 80 mg, 120 mg, and 160 mg (tentative) with matching placebo | Drug | Stage 1: ACC017 and placebo, Stage 2: ACC017 and FTC/TAF (Descovy） |
| Emtricitabine and Tenofovir Alafenamide Fumarate TabletsAlso: DescovyParticipants received a single oral dose of ACC017 tablets with emtricitabine and tenofovir alafenamide fumarate tablets under the fasting condition. | Drug | Stage 2: ACC017 and FTC/TAF (Descovy） |
Primary outcome
Frequency, causality, severity, and expectedness of adverse events (AEs)
Time frame: Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Includes Adverse Drug Reactions [ADRs], Grade 3 and above AEs, and Serious Adverse Events [SAEs], Serious Adverse Drug Reactions [SADRs], AEs resulting in treatment interruptions, AEs resulting in early withdrawal from the trial, and AEs of Special Interest [AESI]
ACC017 PK parameter: Cmax (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
Cmax is defined as the maximum observed concentration of drug
ACC017 PK parameter: C24h (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
C24h is defined as the plasma drug concentrations sampled 24 hours-post dose (C24h)
ACC017 PK parameter: AUC0-t (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
AUC0-t is defined as area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration
ACC017 PK parameter: AUC0-∞ (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
AUC0-∞ is defined as AUC from time zero to infinity
ACC017 PK parameter: Tmax (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
Tmax is defined as the time to reach Cmax
ACC017 PK parameter: t1/2 (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
Half-life
ACC017 PK parameter: Vz/F (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
Apparent volume of distribution during terminal phase after oral administration
ACC017 PK parameter: CL/F (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
Apparent total plasma clearance of drug after oral administration
ACC017 PK parameter: λz (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
Terminal elimination rate constant
ACC017 PK parameter: AUC_%Extrap (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
Percentage of AUCinf due to extrapolation from Tlast to infinity
ACC017 PK parameter: MRT0-t (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
MRT0-t is defined as the mean retention time from time zero to the time of the last measurable plasma concentration
ACC017 PK parameter: MRT0-∞ (after a single mono-drug administration under the fasting condition)
Time frame: Day 1 through Day 8 of Stage 1
MRT0-∞ is defined as MRT from time zero to infinity
20 secondary outcomes
Vital signs: temperature
Time frame: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Vital sign: pulse
Time frame: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Vital signs: blood pressure
Time frame: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Vital signs: respiration
Time frame: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Electrocardiogram (ECG): heart rate
Time frame: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Electrocardiogram (ECG): PR interval
Time frame: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Electrocardiogram (ECG): QRS duration
Time frame: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
Electrocardiogram (ECG): QTc interval
Time frame: Baseline and Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: Cmax
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: C24h
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: AUC0-t
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: AUC0-∞
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: Tmax
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: t1/2
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: Vz/F
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: CL/F
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: λz
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: AUC_%Extrap
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: MRT0-t
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
ACC017 PK parameter: MRT0-∞
Time frame: Day 1 through Day 8 and Day 15 through Day 22 of Stage 2
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 14 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Fujie Zhang, M.D., Ph.D. principal investigator
Beijing Ditan Hospital
Chaoying Hu, Ph.D. principal investigator
Beijing Ditan Hospital
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 ACC017 tablets and Emtricitabine and Tenofovir Alafenamide Fumarate Tablets in people with Healthy Adult Participants, 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 19 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 14 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?
Frequency, causality, severity, and expectedness of adverse events (AEs) (time frame: Day 1 through Day 8 of Stage 1; Day 1 through Day 8 and Day 15 through Day 22 of Stage 2). The study lists 13 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 14 Aug 2026.