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NCT Number: NCT07024160

Phase I Study of MT1011 Injection in Healthy Subjects

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100038, China

Location status: Recruiting

Location contact

Xiao Hua Hao, Ph.D. in Medicine

CONTACT

[email protected]

010-63926883

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

MT1011

Drug

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

Placebo

Drug

This intervention contains no active ingredients

Primary outcomes

  1. Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs).

    Time frame: up to Day 14

    The occurrence of all adverse events (AEs), serious adverse events (SAEs)

Secondary outcomes

  1. Cmax of MT1011

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.

    Cmax - Maximum plasma concentration

  2. Tmax of MT1011

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.

    Tmax - Time to reach Cmax

  3. T1/2 of MT1011

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.

    t1/2 - Elimination half-life

  4. AUC0-tau of MT1011

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.

    AUC0-tau - Area under the plasma concentration-time curve during one dosing interval

  5. AUC0-t of MT1011

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.

    AUC0-t - Area under the plasma concentration-time curve from time zero to the last measurable concentration

  6. Whole blood clotting time

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.

    Whole blood clotting time

  7. Activated partial thromboplastin time

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.

    Activated partial thromboplastin time

  8. Prothrombin time

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.

    Prothrombin time

  9. fibrinogen

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.

    fibrinogen

  10. International normalized ratios

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.

    International normalized ratios

  11. Thrombin time

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.

    Thrombin time

  12. Factor Xa activity

    Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.

    Factor Xa activity

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Hua Hao, Ph.D. in Medicine

CONTACT

[email protected]

010-63926883

Sponsors and collaborators

Lead sponsor

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.