Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Pa… (NCT07408908) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..
48 participantsStarted 2026-03-06
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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/m\^2 ≤ BMI \< 28 kg/m\^2; 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.
✓. Females of childbearing potential and males must agree to use highly effective contraceptive methods (e.g., intrauterine device, condom) from screening until 3 months after administration of the investigational product and have no plan for sperm or egg donation.
Exclusion criteria
✕. 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.
What they're measuring
1
Adverse Event(AE)
Timeframe: Day 1-84
2
Serious Adverse Event
Timeframe: Day 1-84
3
blood pressure
Timeframe: Day 1-84
4
pulse
Timeframe: Day 1-84
5
respiration
Timeframe: Day 1-84
6
body temperature
Timeframe: Day 1-84
7
Number of Participants with Abnormal Physical examination parameters
Timeframe: Day 1-84
8
Number of Participants with Abnormal Laboratory Parameters Findings
Timeframe: Day 1-84
9
Number of Participants with 12-Lead Electrocardiogram Findings
✕. Chronic infectious diseases such as chronic hepatitis B or C, AIDS, tuberculosis, etc. Exclusion applies if any of the following tests are positive at screening: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C antibody (HCVAb), Treponema pallidum antibody, Human Immunodeficiency Virus antibody (HIVAb); or if there is evidence of active or latent Mycobacterium tuberculosis infection at screening.
✕. History of primary immunodeficiency, splenectomy, or any other underlying condition deemed by the investigator to confer a high risk of severe infection.
✕. History of severe food or drug allergy, or known allergy to monoclonal antibodies.
✕. Vaccination with a live attenuated vaccine within 1 month prior to screening, or any other vaccination within half a month prior to screening, or plans to receive any vaccine during the study period.