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

PHASE1CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

July 11, 2023

Primary Completion Date

January 22, 2024

Study Completion Date

February 11, 2024

Conditions
Healthy
Interventions
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.

Trial Locations (1)

101100

Beijing Friendship Hospital, Capital Medical University, Beijing

All Listed Sponsors
lead

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

INDUSTRY