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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
a single 5-mg subcutaneous injection
a single 5-mg subcutaneous injection
a single 25-mg subcutaneous injection
a single 25-mg subcutaneous injection
a single 100-mg subcutaneous injection
a single 100-mg subcutaneous injection
a single 300-mg subcutaneous injection
a single 300-mg subcutaneous injection
a single 600-mg subcutaneous injection
a single 600-mg subcutaneous injection
a single 800-mg subcutaneous injection
a single 800-mg subcutaneous injection
Adverse Event(AE)
Time frame: Day 1-84
Serious Adverse Event
Time frame: Day 1-84
blood pressure
Time frame: Day 1-84
pulse
Time frame: Day 1-84
respiration
Time frame: Day 1-84
body temperature
Time frame: Day 1-84
Number of Participants with Abnormal Physical examination parameters
Time frame: Day 1-84
Number of Participants with Abnormal Laboratory Parameters Findings
Time frame: Day 1-84
Number of Participants with 12-Lead Electrocardiogram Findings
Time frame: Day 1-84
Area Under the plasma concentration-time Curve from time zero to the last measurable concentration(AUC₀-t)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Area Under the plasma concentration-time Curve from time zero extrapolated to infinity(AUC₀-∞)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Maximum observed plasma concentration(Cmax)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Time to reach the maximum observed plasma concentration(Tmax)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Terminal elimination half-life(t1/2)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Apparent clearance (CL/F)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Apparent volume of distribution(Vd/F)
Time frame: Day 1-4,7,14,21,28,42,56,70,84
Levels of BDCA2 on the surface of plasmacytoid dendritic cells (pDCs)
Time frame: Day 1-3,7,14,28,42,56,70,84
Peripheral blood pDC levels
Time frame: Day 1-3,7,14,28,42,56,70,84
Anti-drug antibodies (ADA).
Time frame: Day 1,28,56,84
Neutralizing antibodies (NAb)
Time frame: Day 1,28,56,84
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