RecruitingPhase 1NCT07024160

Phase I Study of MT1011 Injection in Healthy Subjects

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

Sponsor

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

Enrollment

40 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation

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.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called MT1011 and a drug called Placebo for people with used in patients receiving anticoagulant therapy (e.g., rivaroxaban or apixaban, inhibitors of coagulation factor xa) who require reversal of anticoagulation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMT1011

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

DRUGPlacebo

This intervention contains no active ingredients

Locations(1)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT07024160