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.
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]);
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;
Sequential
Matching Placebo
DrugMatching Placebo for ACC085 Injection, administered subcutaneously at the same injection site (periumbilical abdomen or lateral thigh)
Incidence and Severity of Adverse Events (AEs)
To investigate the safety and tolerability by assessment of AEs following administration.
Pharmacokinetic parameters - Area Under the Curve(AUC)
Area Under the Plasma Concentration-time Curve of ACC085
Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration of ACC085
Pharmacokinetic parameters - Time of Peak Concentration(Tmax)
Time to reach maximum observed plasma concentration of ACC085
Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2)
Plasma Elimination Half-Life of ACC085
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