Healthy Adult ParticipantsPhase 1NCT07835633
Single Ascending Dose Study of ACC085 Injection in Healthy Chinese Adults
A Phase 1 study of Healthy Adult Participants, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 30 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign the informed consent form and be able to comply with the requirements of the study procedures;
- Aged 18 to 55 years at the time of signing the informed consent form (≥18 and <56 years), male or female;
- At screening, male body weight ≥50.0 kg, female body weight ≥45.0 kg; body mass index (BMI) = weight (kg)/height² (m²) within the range of 18.5-27.0 kg/m² (inclusive);
- At screening and within 3 months prior to screening, assessed by the investigator to have no risk of HIV 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]);
- Female participants of childbearing potential (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 contraception (including one or more non-pharmacological contraceptive measures, or no heterosexual intercourse in daily life);
- No history of serious medical or surgical diseases prior to screening; vital signs, physical examination, 12-lead electrocardiogram (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.
Who cannot join
- 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)
- History of drug or other substance abuse within 5 years prior to screening;
- Female participants who are pregnant or lactating at screening; (Medical History Restrictions)
- Presence or ongoing clinically significant 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;
- Occurrence or ongoing clinically significant acute diseases within 1 month prior to screening or at screening, such as respiratory tract infection requiring antibiotic treatment;
- Prior to or at screening, known or suspected hypersensitivity to the investigational drug, placebo, or any of their excipients 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.);
Show all 20Show fewer
- 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;
- 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;
- 12-lead ECG exceeding the criteria: QTcF >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)
- 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;
- 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;
- 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;
- 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;
- Special dietary requirements, or inability to accept standardized meals;
- 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)
- Use of strong CYP3A4 inducers (e.g., rifampicin, efavirenz, carbamazepine, phenobarbital, phenytoin, pioglitazone, St. John's Wort, glucocorticoids, 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;
- 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;
- 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;
- 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;
- Participation in any interventional clinical trial including drugs, vaccines or devices within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wuhan Infectious Diseases Hospital
Wuhan, Hubei, 430011
Zhaolin Huang, MMed, +86 15307173189, 88071718@qq.com
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial of Single Ascending Dose of ACC085 Injection in Healthy Chinese Adults
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.
- Conditions
- Healthy Adult Participants
- Being tested
- Matching Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matching PlaceboDrug
Matching Placebo for ACC085 Injection, administered subcutaneously at the same injection site (periumbilical abdomen or lateral thigh)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1：Dose Group 1（94.4 mg，periumbilical abdomen） | Experimental | Participants will receive a single subcutaneous dose of ACC085 Injection 94.4 mg or matching placebo in the periumbilical abdomen. Receives: Drug: Matching Placebo |
| Arm 2：Dose Group 2（314.8 mg，periumbilical abdomen） | Experimental | Participants will receive a single subcutaneous dose of ACC085 Injection 314.8 mg or matching placebo in the periumbilical abdomen. Receives: Drug: Matching Placebo |
| Arm 3：Dose Group 3（944.4 mg，periumbilical abdomen） | Experimental | Participants will receive a single subcutaneous dose of ACC085 Injection 944.4 mg or matching placebo in the periumbilical abdomen. Receives: Drug: Matching Placebo |
| Arm 4：Dose Group 4（944.4 mg，lateral thigh） | Experimental | Participants will receive a single subcutaneous dose of ACC085 Injection 944.4 mg or matching placebo in the lateral thigh. Receives: Drug: Matching Placebo |
| Arm 5：Dose Group 5（X mg，periumbilical abdomen，pending） | Experimental | 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. Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events (AEs)
To investigate the safety and tolerability by assessment of AEs following administration.
Measured: From signing of informed consent to 48 weeks post-dose
Secondary outcomes (4)
Pharmacokinetic parameters - Area Under the Curve(AUC)
Area Under the Plasma Concentration-time Curve of ACC085
Measured: Baseline (pre-dose) and post-dose time points through 48 weeks
Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration of ACC085
Measured: Baseline (pre-dose) and post-dose time points through 48 weeks
Pharmacokinetic parameters - Time of Peak Concentration(Tmax)
Time to reach maximum observed plasma concentration of ACC085
Measured: Baseline (pre-dose) and post-dose time points through 48 weeks
Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2)
Plasma Elimination Half-Life of ACC085
Measured: Baseline (pre-dose) and post-dose time points through 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start31 Aug 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835633
- Sponsor's protocol ID
- ADYY-ACC085-101
- Other IDs
- CTR20263190
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial of Single Ascending Dose of ACC085 Injection in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT07835633
- Acronym / sponsor ID
- ADYY-ACC085-101
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1：Dose Group 1（94.4 mg，periumbilical abdomen） | Experimental | Drug: Matching PlaceboParticipants will receive a single subcutaneous dose of ACC085 Injection 94.4 mg or matching placebo in the periumbilical abdomen. |
| Arm 2：Dose Group 2（314.8 mg，periumbilical abdomen） | Experimental | Drug: Matching PlaceboParticipants will receive a single subcutaneous dose of ACC085 Injection 314.8 mg or matching placebo in the periumbilical abdomen. |
| Arm 3：Dose Group 3（944.4 mg，periumbilical abdomen） | Experimental | Drug: Matching PlaceboParticipants will receive a single subcutaneous dose of ACC085 Injection 944.4 mg or matching placebo in the periumbilical abdomen. |
| Arm 4：Dose Group 4（944.4 mg，lateral thigh） | Experimental | Drug: Matching PlaceboParticipants will receive a single subcutaneous dose of ACC085 Injection 944.4 mg or matching placebo in the lateral thigh. |
| Arm 5：Dose Group 5（X mg，periumbilical abdomen，pending） | Experimental | Drug: Matching PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Voluntarily sign the informed consent form and be able to comply with the requirements of the study procedures;
- Aged 18 to 55 years at the time of signing the informed consent form (≥18 and <56 years), male or female;
- At screening, male body weight ≥50.0 kg, female body weight ≥45.0 kg; body mass index (BMI) = weight (kg)/height² (m²) within the range of 18.5-27.0 kg/m² (inclusive);
- At screening and within 3 months prior to screening, assessed by the investigator to have no risk of HIV 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]);
- Female participants of childbearing potential (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 contraception (including one or more non-pharmacological contraceptive measures, or no heterosexual intercourse in daily life);
Key exclusion criteria (20 listed)
- 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)
- History of drug or other substance abuse within 5 years prior to screening;
- Female participants who are pregnant or lactating at screening; (Medical History Restrictions)
- Presence or ongoing clinically significant 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;
- Occurrence or ongoing clinically significant acute diseases within 1 month prior to screening or at screening, such as respiratory tract infection requiring antibiotic treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matching PlaceboMatching Placebo for ACC085 Injection, administered subcutaneously at the same injection site (periumbilical abdomen or lateral thigh) | Drug | Arm 1：Dose Group 1（94.4 mg，periumbilical abdomen）, Arm 2：Dose Group 2（314.8 mg，periumbilical abdomen）, Arm 3：Dose Group 3（944.4 mg，periumbilical abdomen）, Arm 4：Dose Group 4（944.4 mg，lateral thigh）, Arm 5：Dose Group 5（X mg，periumbilical abdomen，pending） |
Primary outcome
Incidence and Severity of Adverse Events (AEs)
Time frame: From signing of informed consent to 48 weeks post-dose
To investigate the safety and tolerability by assessment of AEs following administration.
4 secondary outcomes
Pharmacokinetic parameters - Area Under the Curve(AUC)
Time frame: Baseline (pre-dose) and post-dose time points through 48 weeks
Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)
Time frame: Baseline (pre-dose) and post-dose time points through 48 weeks
Pharmacokinetic parameters - Time of Peak Concentration(Tmax)
Time frame: Baseline (pre-dose) and post-dose time points through 48 weeks
Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2)
Time frame: Baseline (pre-dose) and post-dose time points through 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy Adult Participants, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinming Yun, Ph.D (＋86 0514-87752666, yunxm@aidea.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (AEs) (time frame: From signing of informed consent to 48 weeks post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.