MT1011 injection safety and single-dose testing in healthy adults
Official title: 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
Run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · NCT07024160 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Shaanxi Micot Pharmaceutical Technology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 25, 2025 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT07024160 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
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MT1013 injection for treating secondary hyperparathyroidism in kidney disease patients on dialysis
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.