Phase Ib/IIa Clinical Study of ACC017 Tablets

ACC017 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase Ib/IIa, randomized, double-blind, parallel, dose ranging, placebo-controlled 'proof of concept' study is designed to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of ACC017 monotherapy and combined with FTC/TAF by sequency versus placebo in treatment-naïve HIV-1 infected adults. This study includes two stages, stage one is a single dose escalation, and all subjects will be co-administrated with FTC/TAF at 200 mg/25 mg on stage two. The study consists of a screening visit, baseline period, monotherapy period, and combination therapy period. Total 36 subjects will be randomized in a 5:1 ratio to receive one of three doses of ACC017 or placebo lasting for 10 days for monotherapy followed by 18 days for combination therapy.

Inclusion Criteria: 1. Willing to sign the informed consent and agree to comply to the study procedures and requests 2. Age range between 18 and 65 years old at the time of signing informed consent, regardless of gender 3. Body weight ≥40 kg, and BMI range between 18.5\~29.9 kg/m2 (including the borderline) at screening 4. Documented HIIV-1 infection before screening, and never receive any antiHIV-1 drugs or vaccines after the diagnosis of HIV-1 infection 5. Agree not to use any antiviral drugs other than those allowed by protocol during study period. 6. Plasma HIV RNA≥5000 copies/mL at screening; 7. CD4+ T-lymphocyte count of \>200 cells/μL Exclusion Criteria: 1. Diagnosis of acute HIV infection at screening or unstable AIDS related disease within 4 weeks prior to screening. 2. Had PrEP and/or PEP treatment within 1 month prior to screening. 3. Had uncontrolled severe disease judged by investigator, such as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, NYHA class III or IV or fasting glucose ≥7.0 mmol/L. 4. History of serious allergy to drugs (such as aspirin or cephalosporin antibiotics) or their ingredients' or food (a fast, life-threatening systemic allergic reaction), or allergic disease requiring drug control (such as asthma, urticaria, atopic dermatitis \[eczema\].). 5. Any major gastrointestinal surgery (except uncomplicated appendectomy or cholecystectomy) or any surgery affecting drug absorption, distribution, metabolism and excretion within 6 months before screening; or possible elective surgery during the trial as judged by the investigator. 6. History of cancer(except cervical carcinoma in situ, or cutaneous basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ \[Bowen's disease\] that received radical surgery or treatment) within 5 years prior to screening. 7. Hb \