Phase Ib/IIa Clinical Study of ACC017 Tablets

NCT06719310 | Recruiting Phase 1

• 1 other identifier: ADYY-ACC017-103&201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (9)

• Report the incidence, severity and seriousness of adverse events, and the relationship between drug and AE

  Report the incidence, severity and seriousness of adverse events, and the relationship between drug and AE

  Day 1- Day 11

• HIV-1 RNA viral load change from baseline

  HIV-1 RNA viral load change from baseline

  Day 11

• Proportion of patients with HIV-1 RNA viral load <50 copies/mL

  Proportion of patients with HIV-1 RNA viral load \<50 copies/mL

  Day 29

• Pharmacokinetics parameter: Cτ,ss

  Cτ,ss is defined as the steady-state plasma drug concentration at the end of the dosing interval after the last administration of a given dose on the monotherapy and combination therapy periods.

  Day 10, Day 29

• Pharmacokinetics parameter: Cmin,ss

  Cmin,ss is defined as the minimum steady-state plasma drug concentration after the last dose of monotherapy.

  Day 10

• Pharmacokinetics parameter: Cmax,ss

  Cmax,ss is defined as the maximum steady-state plasma drug concentration after the last dose of monotherapy.

  Day 10

• Pharmacokinetics parameter: AUC0-τ,ss

  AUC0-τ,ss is defined as the steady-state area under the plasma concentration-time curve from time zero to the any dosing interval of monotherapy.

  Day 1- Day 10

• Pharmacokinetics parameter: Tmax,ss

  Tmax,ss is defined as the time to reach steady-state maximum plasma concentration during monotherapy period.

  Day 1-Day 10

• Pharmacokinetics parameter: MRT0-τ,ss

  MRT0-τ,ss is defined as the steady-state mean residence time from time zero to any dosing interval of monotherapy.

  Day 1-Day 10

Secondary Outcomes (21)

• Changes over time in temperature of vital signs

  Day 1-Day 29

• Changes over time in pulse of vital signs

  Day 1-Day 29

• Changes over time in systolic and diastolic blood pressure of vital signs

  Day 1-Day 29

• Changes over time in respiratory rate of vital signs

  Day 1-Day 29

• Changes over time in heart rate as measured by electrocardiogram(ECG)

  Day 1-Day 29

Study Arms (4)

Participant group 1

EXPERIMENTAL

Stage one: ACC017 (Dose 1) Stage two: ACC017 (Dose 1)+FTC/TAF (200mg/25mg) QD

Drug: ACC017+FTC/TAF

Participant group 2

EXPERIMENTAL

Stage one: ACC017 (Dose 2) Stage two: ACC017 (Dose 2)+FTC/TAF (200mg/25mg) QD

Drug: ACC017+FTC/TAF

Participant group 3

EXPERIMENTAL

Stage one: ACC017 (Dose 3) Stage two: ACC017 (Dose 3)+FTC/TAF (200mg/25mg) QD

Drug: ACC017+FTC/TAF

Participant group 4

PLACEBO COMPARATOR

Stage one: Placebo

Drug: Placebo

Interventions

ACC017+FTC/TAF DRUG

ACC017+FTC/TAF

Participant group 1; Participant group 2; Participant group 3

Placebo DRUG

Placebo

Participant group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the informed consent and agree to comply to the study procedures and requests
• Age range between 18 and 65 years old at the time of signing informed consent, regardless of gender
• Body weight ≥40 kg, and BMI range between 18.5\~29.9 kg/m2 (including the borderline) at screening
• Documented HIIV-1 infection before screening, and never receive any antiHIV-1 drugs or vaccines after the diagnosis of HIV-1 infection
• Agree not to use any antiviral drugs other than those allowed by protocol during study period.
• Plasma HIV RNA≥5000 copies/mL at screening;
• CD4+ T-lymphocyte count of \>200 cells/μL

You may not qualify if:

• Diagnosis of acute HIV infection at screening or unstable AIDS related disease within 4 weeks prior to screening.
• Had PrEP and/or PEP treatment within 1 month prior to screening.
• 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.
• 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 \[eczema\].).
• 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.
• 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.
• Hb \<90 g/L, or WBC count \<1.5×109/L, or ANC count \<0.6×109/L, or platelet count \<50×109/L at screening.
• ALT and/or AST \> 2.5 times upper limit of normal (ULN), or TBIL \> 1.5 × ULN, or DBIL \> ULN, or ALB \<30 g/L at screening.
• SCr \> 1.3 ×ULN, or Ccr \<60 mL/min (Cockcroft-Gault formula) at screening,
• Blood amylase or lipase \>1.5 ×ULN
• Subjects with a positive for HBsAg or anti-HCV, or those with anti-Tp positive who need to be treated required by investigator or their treatment period \<7 days at screening.
• Average smoked cigarettes more than 5 a day within 3 months prior to screening or unwilling to stop using any tobacco products during hospitalization.
• Drinking more than 14 units per week within 3 months prior to screening ( 1 unit of alcohol is equivalent to 5% beer, 45 mL of 40% alcohol, 150mL of 12% alcohol), or a positive alcohol breath test at a screening or baseline visit, or unwilling to stop drink any alcohol-containing product during hospitalization.
• Excessive consumption of tea, coffee or caffeine ( more than 8 cups per day on average, 1 cup of 250 mL) or unwilling to stop drinking tea, coffee, or caffeine during hospitalization.
• Having taken pitaya, mango, grapefruit, star fruit or any preparations made from them, or food/drinking containing xanthine, caffeine or alcohol (e.g.chocolate, tea, coffee, cola and cocoa) or others that will affect the absorption, distribution, metabolism, excretion of drugs, within 48 hours prior to the first dose of experimental drugs, or unwilling to stop taking them during hospitalization.

Sponsors & Collaborators

• Jiangsu Aidea Pharmaceutical Group Co., Ltd.: lead
• Chengdu Aidea Pharmaceutical Technology Co., Ltd: collaborator

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Zhang Fujie, M.D., Ph.D.

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

• Hu C Ying, Ph.D.

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qin Hong, M.D., Ph.D.

CONTACT

025-83193135; qinh@aidea.com.cn

Li Yarong, MMSC

CONTACT

liyarong@aidea.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded in the stage one, open in the stage two
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: August 28, 2024
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CN (1)