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Phase I Study of MT1011 Injection in Healthy Subjects

Phase I Study of MT1011 Injection in Healthy Subjects

Recruiting
18-45 years
All
Phase 1

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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.

Eligibility

Inclusion Criteria:

  1. Healthy male or female subjects (with at least 1/4 being either female or male), aged 18 to 45 years (inclusive) at screening;
  2. 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);
  3. Subjects must provide informed consent for this study prior to participation and voluntarily sign a written informed consent form;
  4. Subjects must be able to maintain good communication with the investigators.

Exclusion Criteria:

  1. 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;
  2. 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

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

NCT07024160

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

15 October 2025

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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