Phase I Study of MT1011 Injection in Healthy Subjects

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: Placebo; Drug: MT1011

Study type: Interventional

Funder types: Industry

Identifiers

NCT07024160

MT1011-I-C02

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

MT1011

Experimental group

Description:

Interventional: The SAD study involves single administration of MT1011

Treatment:

Drug: MT1011

Placebo

Placebo Comparator group

Description:

Placebo: The SAD study involves single administration of Placebo.

Treatment:

Drug: Placebo