Phase I Study of MT1011 Injection in Healthy Subjects

Launched by SHAANXI MICOT PHARMACEUTICAL TECHNOLOGY CO., LTD. · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called MT1011, which is designed to help people who are taking blood thinners like rivaroxaban or apixaban and may need their blood thinning effects reversed quickly, for example, in an emergency. The study is in the very early Phase 1 stage and is focused on making sure the medicine is safe and understanding how it behaves in the body. The trial will include healthy adults who receive different doses of the medicine or a placebo (a substance with no active drug) to see how their bodies respond.

To join the study, participants need to be healthy men or women between 18 and 45 years old, with a certain range of body weight and body mass index (a measure of body fat). Participants must be willing to give informed consent, meaning they understand the study and agree to take part. During the study, volunteers will be closely monitored through physical exams and lab tests to ensure their safety. Women who are pregnant, breastfeeding, or planning to become pregnant cannot take part. This study is currently recruiting volunteers and aims to enroll about 40 people in total.

Gender

ALL

Eligibility criteria

• 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