Trials / Recruiting

RecruitingNCT07024160

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

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 40 (estimated)

Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
Sex: All
Age: 18 Years – 45 Years
Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

Start date: 2025-06-25
Primary completion: 2026-04-01
Completion: 2026-04-01
First posted: 2025-06-17
Last updated: 2025-07-03

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07024160. Inclusion in this directory is not an endorsement.