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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

Inclusion Criteria4

  • Healthy male or female subjects (with at least 1/4 being either female or male), aged 18 to 45 years (inclusive) at screening;
  • Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening, with a Body Mass Index \[BMI = weight (kg) / height² (m²)\] within the range of 18.5 to 26.0 kg/m² (inclusive);
  • Subjects must provide informed consent for this study prior to participation and voluntarily sign a written informed consent form;
  • Subjects must be able to maintain good communication with the investigators.

Exclusion Criteria2

  • Subjects with abnormal and clinically significant findings in vital signs, physical examination, laboratory tests (blood routine, urinalysis, blood biochemistry, coagulation function), abdominal ultrasound, or chest X-ray as determined by the investigator;
  • Women who are pregnant or breastfeeding, or female subjects with positive pregnancy tests; Subjects (or their partners) planning pregnancy, or planning to donate sperm/ova during the study or within
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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