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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

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Trial Profile

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 of Trial: Phase I

Latest Information Update: 03 Mar 2026

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At a glance

  • Drugs ACT 100 (Primary)
  • Indications Cutaneous lupus erythematosus; Systemic lupus erythematosus
  • Focus Adverse reactions
  • Sponsors Xiamen Amoytop Biotech

Most Recent Events

  • 03 Mar 2026 New trial record
  • 31 Jan 2026 According to Xiamen Amoytop Biotech media release, the clinical trial application for ACT100 was successfully included in the '30-Day Review Channel' under the Announcement on Optimizing the Review and Approval of Innovative Drug Clinical Trials (No. 86 of 2025) issued by the NMPA on September 12, 2025.
  • 31 Jan 2026 According to Xiamen Amoytop Biotech media release, the company announced that it has received the Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA) for ACT100 for Injection for the indications of Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE).

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