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Recruiting NCT07024160

Phase I Study of MT1011 Injection in Healthy Subjects

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MT1011, Placebo.
Who it may be relevant to
Registry conditions: Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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

Primary outcome measures

  • Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs). [Time frame: up to Day 14]
Secondary outcome measures (12)
  • 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.]
  • 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.]
  • 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.]
  • 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-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.]
  • Whole blood clotting time [Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.]
  • Activated partial thromboplastin time [Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.]
  • Prothrombin time [Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.]
  • fibrinogen [Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.]
  • International normalized ratios [Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.]
  • Thrombin time [Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.]
  • Factor Xa activity [Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Shijitan Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07024160 · MT1011-I-C02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗