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NOT YET RECRUITING
NCT07408908
PHASE1

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

Sponsor: Xiamen Amoytop Biotech Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-03-06

Completion Date

2027-10-30

Last Updated

2026-02-13

Healthy Volunteers

Yes

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