NCT07408908

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

A Single-Center, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled, Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Systemic Lupus Erythematosus
• Cutaneous Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	ACT100 Injection	a single 5-mg subcutaneous injection
DRUG	Placebo for ACT100	a single 5-mg subcutaneous injection
DRUG	ACT100 Injection	a single 25-mg subcutaneous injection
DRUG	Placebo for ACT100	a single 25-mg subcutaneous injection
DRUG	ACT100 Injection	a single 100-mg subcutaneous injection
DRUG	Placebo for ACT100	a single 100-mg subcutaneous injection
DRUG	ACT100 Injection	a single 300-mg subcutaneous injection
DRUG	Placebo for ACT100	a single 300-mg subcutaneous injection
DRUG	ACT100 Injection	a single 600-mg subcutaneous injection
DRUG	Placebo for ACT100	a single 600-mg subcutaneous injection
DRUG	ACT100 Injection	a single 800-mg subcutaneous injection
DRUG	Placebo for ACT100	a single 800-mg subcutaneous injection

Timeline

• Start date: 2026-03-06
• Primary completion: 2027-03-30
• Completion: 2027-10-30
• First posted: 2026-02-13
• Last updated: 2026-02-13