RecruitingPhase 1

Phase I Study of MT1011 Injection in Healthy Subjects

China40 participantsStarted 2025-06-25

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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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

What they're measuring

Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs).

Timeframe: up to Day 14

Trial details

NCT IDNCT07024160

SponsorShaanxi Micot Pharmaceutical Technology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04

Contact for this trial

Xiao Hua Hao, Ph.D. in Medicine

010-63926883 xiaohualuck@sina.com

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