MedTrace Logo

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

NCT05948774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-11-21

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Shaanxi Micot Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • RuiHua Dong, PhD · Beijing Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2024-01-22
Completion
2024-02-11
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05948774 on ClinicalTrials.gov