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Phase I Study of MT1011 Injection in Healthy Subjects | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Phase I Study of MT1011 Injection in Healthy Subjects

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

NCT07024160•Shaanxi Micot Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

June 25, 2025

Primary Completion Date

April 1, 2026

Completion Date

April 1, 2026

Last Updated

July 3, 2025

Enrollment

ESTIMATED participants

Conditions

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

Interventions

MT1011

DRUG

Placebo

DRUG

Contacts

Xiao Hua Hao, Ph.D. in Medicine

CONTACT

010-63926883 xiaohualuck@sina.com