This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of ACT100 in healthy participants. A total of 6 dose cohorts are planned, with each cohort enrolling 8 participants (including both male and female participants, where 6 will receive the investigational drug and 2 will receive placebo). The total planned enrollment is 48 healthy participants.
Participants must voluntarily participate and sign the informed consent form after being informed of the entire trial process and the potential adverse reactions of the investigational product.
Healthy male and female participants aged between 18 and 55 years (inclusive) at the time of signing the informed consent form.
Body mass index (BMI) at screening: 18.5 kg/m² ≤ BMI < 28 kg/m²; body weight ≥ 50 kg (for males) / ≥ 45 kg (for females).
At screening, physical examination, vital signs, laboratory tests, electrocardiogram (ECG), etc., are all normal or show abnormalities judged by the investigator as having no clinical significance.
History of treatment with any drug targeting the same molecule (BDCA2) as the investigational product.
A 12-lead electrocardiogram (ECG) at screening showing abnormalities considered clinically significant by the investigator (e.g., QTcF > 450 ms for males or > 470 ms for females).
History of severe diseases of major organ systems, including but not limited to neurological, cardiovascular, hematological, autoimmune, renal, hepatic, gastrointestinal, pulmonary, endocrine, metabolic, or psychiatric disorders.
Presence of severe bacterial or viral infection (e.g., pneumonia, sepsis, herpes zoster), or fungal/parasitic infection within 2 months prior to screening; or any symptoms of active or suspected infection within 1 week prior to dosing.
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Treatment groupsSee each treatment group below.
Xiamen Amoytop Biotech Co., Ltd.
Lead sponsor
Peking Union Medical College Hospital
Collaborator