MT1011 injection safety and single-dose testing in healthy adults
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
This study will test whether single doses of MT1011 are safe and how the body processes them in healthy adults aged 18–45.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Shaanxi Micot Pharmaceutical Technology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07024160 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized, double-blind, placebo-controlled Phase I single-ascending-dose trial enrolling about 40 healthy adult volunteers across five dose cohorts. The study will collect safety data and measure pharmacokinetics (PK) and pharmacodynamics (PD) after a single injection of MT1011 or placebo. Investigators will monitor vital signs, labs, and adverse events and compare results across dose levels to determine tolerability and dosing signals. Results will inform whether further testing in patients who need anticoagulation reversal is appropriate.
Who should consider this trial
Good fit: Healthy men and women aged 18–45 with BMI 18.5–26.0 and minimum weight requirements who can give informed consent and comply with study visits are eligible.
Not a fit: People actively taking anticoagulant medications, those with abnormal clinical or laboratory findings, pregnant or breastfeeding women, or those planning pregnancy would not benefit from participating in this healthy-volunteer safety study.
Why it matters
Potential benefit: If successful, MT1011 could become a new option to rapidly reverse anticoagulation in patients taking factor Xa inhibitors who need urgent reversal.
How similar studies have performed: Approved reversal agents for factor Xa inhibitors exist, but MT1011 is a novel candidate with no published human efficacy data yet and is being tested first for safety and PK in healthy volunteers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Beijing Shijitan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiao Hua Hao, Ph.D. in Medicine
- Email: xiaohualuck@sina.com
- Phone: 010-63926883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.