Phase I Study of MT1011 Injection in Healthy Subjects
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation
In brief
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.
Key facts
- Study ID
- NCT07024160
- Run by
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- People needed
- 40
- Starts
- 2025-06-25
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2025-07-03
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Beijing Shijitan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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