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

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

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

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• Xiamen Amoytop Biotech Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Xiaohong Han · Peking Union Medical College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-06

Primary Completion

2027-03-30

Completion

2027-10-30