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drugset / Trial / NCT05948774

A SAD/MAD Study to Evaluate the Safety, Tolerability, PK of MT200605 in Healthy Subjects

NCT05948774 ↗

Phase 1 Completed 61 enrolled Shaanxi Micot Pharmaceutical Technology Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this randomized, double-blind, placebo control, Phase I clinical trial is to evaluate the Safety, Tolerability, and Pharmacokinetics after Single Ascending Dose (SAD) and multiple Ascending Dose (MAD) of MT200605 for Injection in Healthy Subjects. The main questions it aims to answer are: 1. The safety and tolerability of MT200605 injection in health subjects 2. The Pharmacokinetic characteristic of MT200605 injction in health subjects The study aims to recruit 60 health subjects and participants will be randomly allocate to two stages (SAD and MAD) with 36 subjects in SAD and 24 subjects in MAD stages. The placebo will be used in this study, and the researchers will compare the placebo and test article to see if the MT200605 will be safe or well tolerated.

Timeline

Start
2023-07-11
Primary completion
2024-01-22
Completion
2024-02-11

Drugs

EvaluationDrugModalityDoseRoute
Subject MT200605 Small molecule 0.15 mg/kg Intravenous
Subject MT200605 Small molecule 0.3 mg/kg Intravenous
Subject MT200605 Small molecule 0.6 mg/kg Intravenous
Subject MT200605 Small molecule 0.9 mg/kg Intravenous
Subject MT200605 Small molecule 1.2 mg/kg Intravenous

Indications

No indication recorded.