Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..

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.

NCT Number	NCT07408908
Lead Sponsor	Xiamen Amoytop Biotech Co., Ltd. Collaborators: Peking Union Medical College Hospital
Conditions	Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Enrollment	48 participants
Start Date	2026-03-06
Primary Completion	2027-03-30 (estimated)
Study Completion	2027-10-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-13