drugset / Trial / NCT07408908

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

NCT07408908 ↗

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-03-06
Primary completion
2027-03-30
Completion
2027-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject ACT100 Unknown 5 mg Subcutaneous
Subject ACT100 Unknown 25 mg Subcutaneous
Subject ACT100 Unknown 100 mg Subcutaneous
Subject ACT100 Unknown 300 mg Subcutaneous
Subject ACT100 Unknown 600 mg Subcutaneous
Subject ACT100 Unknown 800 mg Subcutaneous