ACC017

Associated long-acting platforms

Oral solid form

Administration route

Oral

Therapeutic area(s)

Use case(s)

Use of drug

Dosage

Drug information

Delivery device(s)

Not provided

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

ADYY-ACC017-103&201

Identifier

NCT06719310

Link

https://clinicaltrials.gov/study/NCT06719310

Phase

Phase I/II

Status

Completed

Sponsor

Jiangsu Aidea Pharmaceutical Group Co., Ltd.

More details

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 f

Purpose

Phase Ib/IIa Clinical Study of ACC017 Tablets

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2024-08-28

Anticipated Date of Last Follow-up
2026-08-12

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2025-04-28

Actual Completion Date
2025-04-28

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

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 PrE

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

36

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Not provided

Studied route(s) of administration

Not provided

Use case

Not provided

Key resources

CTR20253999-Ph3-TT-Naive-Adults

Identifier

CTR20253999

Link

http://www.chinadrugtrials.org.cn/

Phase

Phase III

Status

Recruiting

Sponsor

Jiangsu Aidea Pharmaceutical Group Co., Ltd.

More details

Multicentre, randomised, double-blind, double-dummy, dolutegravir-controlled phase 3 in treatment-naive adults with HIV-1; about 660 participants; 48-week treatment period; 14 centres. Launched 11 October 2025 in Yangzhou; first participant enrolled subsequently.

Purpose

Efficacy and safety of ACC017 versus dolutegravir in treatment-naive adults with HIV-1

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-10-11

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Study type

Interventional (clinical trial)

Enrollment

660

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CTR20250437-NNRTI-resistant-adults

Identifier

CTR20250437

Link

http://www.chinadrugtrials.org.cn/

Phase

Phase II

Status

Active, not recruiting

Sponsor

Jiangsu Aidea Pharmaceutical Group Co., Ltd.

More details

ACC017-based regimen in treatment-experienced adults with NNRTI-resistant HIV-1

Purpose

Not provided

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Treatment-experienced adults with NNRTI-resistant HIV-1.

Health status

Study type

Interventional (clinical trial)

Enrollment

Not provided

Allocation

Non-randomized

Intervention model

Not provided

Intervention model description

unclear study design

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

CTR20240167

Identifier

CTR20240167

Link

http://www.chinadrugtrials.org.cn/

Phase

Phase I

Status

Completed

Sponsor

Jiangsu Aidea Pharmaceutical Group Co., Ltd.

More details

Not provided

Purpose

Not provided

Interventions

Not provided

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort
Unspecified

Genders
Unspecified

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Unspecified

Comments about the studied populations

Not provided

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

Not provided

Allocation

Not provided

Intervention model

Not provided

Intervention model description

Not provided

Masking

Not provided

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL

Publications

Selected Highlights From the 26th International Workshop on Clinical Pharmacology of HIV, Hepatitis, and Other Antiviral Drugs

Scarsi Kim — Top Antivir Med — 2026-07-16

Clinical pharmacology plays a crucial role in the successful treatment and prevention of HIV and other viral infections. Information from the field of clinical pharmacology leads to the development of novel antiviral treatments, supports the evaluation of efficacy and safety of antiviral therapies, informs the management of drug-drug interactions, and defines the optimal dosing and drug selection for special populations. The International Workshop on Clinical Pharmacology of HIV, Hepatitis, and Other Antiviral Drugs recently held its 26th meeting. This review focuses on selected abstracts presented at the 2025 workshop and provides insights to assist clinicians in applying this new knowledge to clinical practice.

Anti-HIV-1 Activity of the Integrase Strand Transfer Inhibitor ACC017

Meng-Di Ma — Viruses — 2025-12-24

HIV-1 integrase strand transfer inhibitors (INSTIs) are pivotal to antiretroviral therapy. However, the emergence of drug-resistant mutations necessitates the development of new agents. Here, we present ACC017 as a novel INSTI candidate. ACC017 demonstrated potent activity against the laboratory-adapted HIV-1IIIB strain (EC50 = 0.59 nM; SI > 34,525) and maintained efficacy against a panel of drug-resistant strains (EC50 range from 0.34 to 9.12 nM) and clinical isolated strains (EC50 range from 0.11 to 1.78 nM). Mechanism of action studies confirmed its ability to inhibit the integrase enzyme (IC50 = 9.19 nM) and effectively block viral genome integration. Notably, in vitro resistance selection primarily yielded D232N and R263K mutations, without the emergence of G140S/A/C/R or Q148H/R/K. This promising profile, combined with synergistic interactions with other antiretroviral drugs, positions ACC017 as a potential therapeutic option.

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Useful links

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