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RECRUITING
NCT07024160
PHASE1

Phase I Study of MT1011 Injection in Healthy Subjects

Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a single-center, randomized,double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) of MT1011 injection in healthy adult subjects. Includes 5 dose cohorts, with 40 subjects planned for enrollment.

Official title: A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) Administration of MT1011 Injection in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-06-25

Completion Date

2026-04

Last Updated

2025-07-03

Healthy Volunteers

Yes

Interventions

DRUG

MT1011

MT1011 is a novel synthetic small molecule anticoagulant reversal agent for reversing anticoagulant effects including factor IIa and Xa inhibitors.

DRUG

Placebo

This intervention contains no active ingredients

Locations (1)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China