ClinicalTrials.gg
RecruitingNCT07835633Updated Sep 25, 2026

Single Ascending Dose Study of ACC085 Injection in Healthy Chinese Adults

A Phase 1 interventional study of Matching Placebo in Healthy Adult Participants, sponsored by Jiangsu Aidea Pharmaceutical Group Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Jiangsu Aidea Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Sep 25, 2026Title changedGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This trial is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) Phase I clinical trial conducted in healthy Chinese adults to evaluate the safety, tolerability and PK profiles of a single subcutaneous administration of ACC085 injection in healthy Chinese adults.

This is a single ascending dose study planned to enroll participants into 5 dose groups [94.4 mg (periumbilical abdomen), 314.8 mg (periumbilical abdomen), 944.4 mg (periumbilical abdomen), 944.4 mg (lateral thigh), and a pending dose of X mg (periumbilical abdomen), which will be determined based on clinical progress]. Except for Dose Group 3, which plans to enroll 15 participants with a 4:1 ratio of participants receiving investigational product to placebo, all other dose groups will enroll 8 participants each with a 3:1 ratio of participants receiving investigational product to placebo. After all participants in Dose Group 1 complete the 4-week safety and tolerability assessment, if the dose-escalation stopping criteria have not been met, ACC085 will be escalated sequentially to Dose Groups 2-5 (314.8-944.4 mg and pending Dose Group X mg) with reference to the Fibonacci method and PK findings. Participant follow-up will continue until 48 weeks after dosing.

02

Conditions studied

  • Healthy Adult Participants
03

In context

Lead sponsor

Jiangsu Aidea Pharmaceutical Group Co., Ltd. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily sign the form and be able to comply with the requirements of the study procedures;
  2. Aged 18 to 55 years at the time of signing the informed consent form (≥18 and \<56 years), male or female;
  3. At screening, male body weight ≥50.0 kg, female body weight ≥45.0 kg; (BMI) = weight (kg)/height² (m²) within the range of 18.5-27.0 kg/m² (inclusive);
  4. At screening and within 3 months prior to screening, assessed by the investigator to have no risk of infection (HIV high-risk populations include, but are not limited to, men who have sex with men, intravenous drug users, sex workers, individuals who have unprotected sex with sex workers, individuals with multiple sexual partners, or individuals with concurrent sexually transmitted infections [STIs]);
  5. Female participants of (WOCBP) and male participants have no plans to conceive (including sperm or oocyte donation) from 1 month prior to informed consent to 1 year after dosing, and agree to use effective (including one or more non-pharmacological contraceptive measures, or no heterosexual intercourse in daily life);
  6. No history of serious medical or surgical diseases prior to screening; vital signs, physical examination, 12-lead (ECG), laboratory tests (complete blood count, serum biochemistry, coagulation function, urinalysis, infectious disease screening, pregnancy test for females, urine drug abuse screening), chest X-ray and breath alcohol test results at screening are normal, or slightly outside the normal reference range but judged by the investigator to be clinically insignificant.

Exclusion criteria

Exclusion Criteria:

  1. The investigator judges that the participant has poor treatment compliance or study procedure adherence, or has any other condition unsuitable for participation in this study, or participation in this study cannot maximally protect the participant's health rights and interests; (Population Restrictions)
  2. History of drug or other substance abuse within 5 years prior to screening;
  3. Female participants who are pregnant or lactating at screening; (Medical History Restrictions)
  4. Presence or ongoing chronic diseases prior to or at screening, including but not limited to diseases of the cardiovascular and cerebrovascular system, respiratory system, digestive system (any history of gastrointestinal diseases affecting drug absorption), urinary system, hematologic and lymphatic system, endocrine system, musculoskeletal system, immune system, and neuropsychiatric system;
  5. Occurrence or ongoing clinically significant acute diseases within 1 month prior to screening or at screening, such as respiratory tract infection requiring antibiotic treatment;
  6. Prior to or at screening, known or suspected to the drug, placebo, or any of their as assessed by the investigator; or history of allergic diathesis (multiple drug and food allergies), or history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.);
  7. Surgery that may affect drug absorption, distribution, metabolism and excretion within 6 months prior to screening or at screening, or plan to undergo major surgery during the study;
  8. Unable to tolerate venipuncture prior to or at screening, or history of needle phobia or hematophobia; blood donation including apheresis blood donation or significant blood loss (≥400 mL), or blood transfusion received within 3 months prior to screening or at screening; or plan to donate blood or receive blood transfusion during the study;
  9. 12-lead exceeding the criteria: >450 ms for males, QTcF >470 ms for females; or ECG abnormalities judged clinically significant by the investigator (e.g., atrioventricular block, torsades de pointes (TdP), other types of ventricular tachycardia, ventricular fibrillation and ventricular flutter, clinically significant T-wave changes, or any abnormal 12-lead ECG findings affecting QTc interval); (Lifestyle Restrictions)
  10. Average daily consumption greater than 10 cigarettes or equivalent tobacco products within 3 months prior to screening or at screening, or inability to stop using any tobacco products during the inpatient study period;
  11. Average weekly alcohol consumption greater than 14 units within 3 months prior to screening or at screening (1 unit of alcohol ≈360 mL beer or 45 mL of 40% strength spirits or 150 mL wine), or inability to refrain from any alcohol-containing products during the inpatient study period;
  12. Excessive daily consumption of tea, coffee and/or caffeine-containing beverages (average >8 cups, 1 cup ≈250 mL) within 3 months prior to screening or at screening, or inability to stop drinking tea, coffee and/or caffeine-containing beverages during the inpatient study period;
  13. Inability to refrain from consuming pitaya, mango, pomelo, carambola, or foods/beverages prepared from them, or foods/beverages containing xanthine, caffeine or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diets affecting drug absorption, distribution, metabolism and excretion within 48 h prior to study drug administration;
  14. Special dietary requirements, or inability to accept standardized meals;
  15. Tattoos or other skin conditions at the injection site assessed by the investigator as potentially interfering with the assessment of injection site reactions; (Medication History Restrictions)
  16. Use of strong inducers (e.g., rifampicin, efavirenz, carbamazepine, phenobarbital, phenytoin, pioglitazone, St. John's Wort, , etc.) or strong/moderate CYP3A inhibitors (e.g., voriconazole, clarithromycin, telithromycin, ketoconazole, itraconazole, nefazodone, etc.) within 28 days prior to screening or 5 drug half-lives, whichever is longer;
  17. Use of strong or moderate UGT1A inhibitors (e.g., silybin, ritonavir, atazanavir, quinidine, diclofenac, mycophenolic acid, osimertinib, etc.) or strong UGT1A1 inducers (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin, etc.) within 28 days prior to screening or 5 drug half-lives, whichever is longer;
  18. Use of P-gp inhibitors (e.g., ranolazine, verapamil, itraconazole, clarithromycin, quinidine, ritonavir) or P-gp substrates (e.g., dabigatran, fexofenadine, digoxin) within 28 days prior to screening or 5 drug half-lives, whichever is longer;
  19. Use of any prescription drugs, over-the-counter drugs or Chinese herbal medicines within 14 days prior to screening or 5 drug half-lives, whichever is longer;
  20. Participation in any interventional clinical trial including drugs, vaccines or devices within 3 months prior to screening.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
47 participants (estimated)

Study arms

  • Experimental
    Arm 1:Dose Group 1(94.4 mg,periumbilical abdomen)

    Participants will receive a single subcutaneous dose of ACC085 Injection 94.4 mg or matching placebo in the periumbilical abdomen.

    Drug: Matching Placebo

  • Experimental
    Arm 2:Dose Group 2(314.8 mg,periumbilical abdomen)

    Participants will receive a single subcutaneous dose of ACC085 Injection 314.8 mg or matching placebo in the periumbilical abdomen.

    Drug: Matching Placebo

  • Experimental
    Arm 3:Dose Group 3(944.4 mg,periumbilical abdomen)

    Participants will receive a single subcutaneous dose of ACC085 Injection 944.4 mg or matching placebo in the periumbilical abdomen.

    Drug: Matching Placebo

  • Experimental
    Arm 4:Dose Group 4(944.4 mg,lateral thigh)

    Participants will receive a single subcutaneous dose of ACC085 Injection 944.4 mg or matching placebo in the lateral thigh.

    Drug: Matching Placebo

  • Experimental
    Arm 5:Dose Group 5(X mg,periumbilical abdomen,pending)

    Participants will receive a single subcutaneous dose of ACC085 Injection X mg (pending dose to be determined based on clinical progress) or matching placebo in the periumbilical abdomen.

    Drug: Matching Placebo

Interventions

  • DrugMatching Placebo

    Matching Placebo for ACC085 Injection, administered subcutaneously at the same injection site (periumbilical abdomen or lateral thigh)

06

What researchers measure

Primary outcomes

  1. Incidence and Severity of Adverse Events (AEs)

    To investigate the safety and tolerability by assessment of AEs following administration.

    Time frame: From signing of informed consent to 48 weeks post-dose

Secondary outcomes

  1. Pharmacokinetic parameters - Area Under the Curve(AUC)

    Area Under the Plasma Concentration-time Curve of ACC085

    Time frame: Baseline (pre-dose) and post-dose time points through 48 weeks

  2. Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)

    Maximum Observed Plasma Concentration of ACC085

    Time frame: Baseline (pre-dose) and post-dose time points through 48 weeks

  3. Pharmacokinetic parameters - Time of Peak Concentration(Tmax)

    Time to reach maximum observed plasma concentration of ACC085

    Time frame: Baseline (pre-dose) and post-dose time points through 48 weeks

  4. Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2)

    Plasma Elimination Half-Life of ACC085

    Time frame: Baseline (pre-dose) and post-dose time points through 48 weeks

07

Study locations

1 of 1 sites recruiting
  • Wuhan Infectious Diseases Hospital
    Wuhan, Hubei 430011, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2026
First posted
Sep 23, 2026
StartActual
Aug 31, 2026
Primary completionEst.
Jul 30, 2028
CompletionEst.
Jul 30, 2028
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Title
Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Single Ascending Dose Study of ACC085 Injection in Healthy Chinese Adults
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Title Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Single Ascending Dose Study of ACC085 Injection in Healthy Chinese Adults

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07835633
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Aug 31, 2026
Primary completion
Jul 30, 2028 (estimated)
Completion
Jul 30, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Xinming Yun, Ph.D
Contact
yunxm@aidea.com.cn
+86 0514-87752666
Yuanjing Duan, MSc
Contact
duanyuanjing@aidea.com.cn
+86 0514-87752666

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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