NCT05948774

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

A Randomized, Double-blind, Placebo Control, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) of MT200605 for Injection in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Shaanxi Micot Technology Co. Ltd. is developing MT200605, a novel investigational synthetic small molecule tyrosine kinase B (TrkB) receptor agonist to mimic brain-derived neurotrophic factor (BDNF). It can directly bind to TrkB receptor to exert strong neuroprotective and nutritional effects and used for the indication of Treatment of brain tissue damage after cerebral ischemia-reperfusion and nerve repair after ischemic stroke. 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 study was divided into two stages including 5 groups in SAD stage and 3 groups in MAD stage. 4 subjects were in the first corhort (C1) of SAD stage while the rest of the corhorts were 8 cases. The MT200605 and Placebo will be administrated by Intravenous injection.The dose level in SAD will be 0.15 (C1), 0.3(C2), 0.6(C3), 0.9(C4), and 1.2(C5) mg/kg. The dose level will be adjusted based on the safety and PK data of the completed SAD corhort. The dose level in MAD will be 0.3(C6), 0.6(C7), and 1.2(C8) mg/kg. The dose level will be adjusted based on the safety and PK data of the completed SAD and MAD corhort.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MT200605 for Injection	Two stages (SAD, MAD) were designed in this study. For SAD, the MT200605 will single Intravenous (IV) infusion for 1h with the dose level as 0.15 mg/kg、0.3 mg/kg、0.6 mg/kg、0.9 mg/kg、1.2 mg/kg. For MAD, the participants will IV infusion of the MT200605 for 7 days with 2 times per day under the dose level of 0.3 mg/kg、0.6 mg/kg、1.2 mg/kg. The dosing frequency will be Q12h. The drug/placebo in day 7 will be only administrated for 1 time on morning. The infusion duration will be 1h.
DRUG	MT200605 Placebo	Two stages (SAD, MAD) were designed in this study. For SAD, the MT200605 Placebo will single Intravenous (IV) infusion for 1h with the dose level as 0.15 mg/kg、0.3 mg/kg、0.6 mg/kg、0.9 mg/kg、1.2 mg/kg. For MAD, the participants will IV infusion of the MT200605 Placebo for 7 days with 2 times per day under the dose level of 0.3 mg/kg、0.6 mg/kg、1.2 mg/kg. The dosing frequency will be Q12h. The drug/placebo in day 7 will be only administrated for 1 time on morning. The infusion duration will be 1h.

Timeline

• Start date: 2023-07-11
• Primary completion: 2024-01-22
• Completion: 2024-02-11
• First posted: 2023-07-17
• Last updated: 2024-11-21

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study