Phase I Study of MT1011 Injection in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-25

Study Completion Date

2026-04-30

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MT1011

Interventional: The SAD study involves single administration of MT1011

Group Type EXPERIMENTAL

MT1011

Intervention Type DRUG

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

Placebo

Placebo: The SAD study involves single administration of Placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

This intervention contains no active ingredients

Interventions

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MT1011

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

Intervention Type DRUG

Placebo

This intervention contains no active ingredients

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes