Last updated: March 4, 2024
Sponsor: Jiangsu Aidea Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting
Phase
1
Condition
N/ATreatment
ACC017 tablets
Emtricitabine and Tenofovir Alafenamide Fumarate Tablets
Clinical Study ID
NCT06278389
ADYY-ACC017-101
CTR20240167
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Volunteering to sign the informed consent and able to follow protocol-definedprocedural 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 spermor egg donation) and agreeing to use effective contraception (including one or morenon-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 studymedication;
- No history of significant medical or surgical illness, and normal results on vitalsigns, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, chestX-ray and abdominal ultrasound examination during the screening period, or minordeviations from normal reference values that are not clinically significant in thejudgment of the investigator.
Exclusion
Exclusion Criteria:
- Occurrence or persistence of clinically significant abnormal conditions, including butnot limited to cardiovascular, respiratory, gastrointestinal (any history ofgastrointestinal disorders affecting the absorption of medications), urinary,hematologic and lymphatic, endocrine, musculoskeletal, immune, and neuropsychiatricdisorders;
- Possible or definite allergic reaction to the study drug, placebo, or any of theexcipients contained, as judged by the investigator, or allergy (multiple drug andfood sensitivities), or a history of allergic disease (e.g., asthma, urticaria, andeczematous 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) orreceipt of blood transfusion within 3 months prior to screening, or planning to donateblood during the trial period;
- Dysphagia, or surgery within 6 months prior to screening, or surgery planned duringthe 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, orinability to stop using any tobacco-based product during the trial period;
- Average weekly alcohol consumption greater than 14 units (1 unit of alcohol ≈ 360 mLof beer, or 45 mL of 40% (alcohol by volume) spirits, or 150 mL of wine) within 3months prior to screening or inability to discontinue use of any alcohol-containingproduct during the trial period, or with a positive breath test for alcohol atscreening;
- Excessive consumption of tea, coffee, and/or caffeinated beverages (more than 8 cupson average per day, 1 cup ≈ 250 mL) within 3 months prior to screening, or inabilityto stop consuming tea, coffee, and/or caffeinated beverages during the trial period;
- Consumption or drinking of dragon fruit, mango, grapefruit, popcorn, or foods orbeverages prepared from the aforementioned fruits, or foods or beverages containingxanthines, 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 thestudy 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 islonger) before screening;
- Use of strong or moderate UGT1A inhibitors (e.g., silybin, ritonavir, atazanavir,quinidine, diclofenac, mycophenolic acid, and osimertinib, etc.) or strong UGT1A1inducers (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) medicineswithin 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 bythe 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 atscreening;
- History of substance abuse within 5 years prior to screening, or positive urine drugscreen at screening;
- Females who are pregnant or lactating at the time of screening, or have a positiveblood pregnancy test (for WOCBP only);
- Participation in any interventional clinical trials, including drugs, vaccines, ordevices, etc., within 3 months prior to screening,;
- It is not suitable for a participant to participate in this trial in the judgment ofthe investigator.
Study Design
Total Participants: 52
Treatment Group(s): 2
Primary Treatment: ACC017 tablets
Phase: 1
Study Start date:
January 24, 2024
Estimated Completion Date:
April 23, 2024
Study Description
Connect with a study center
Beijing Ditan Hospital Affiliated to Capital Medical University
Beijing, 100015
ChinaActive - Recruiting
Beijing Ditan Hospital Capital Medical University
Beijing, 100015
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.