Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of AnticoagulationPhase 1NCT07024160
Phase I Study of MT1011 Injection in Healthy Subjects
A Phase 1 study testing MT1011 in people with Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation
- What is being tested?
- MT1011
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100038
Xiao Hua Hao, Ph.D. in Medicine, 010-63926883, xiaohualuck@sina.com
About this study
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
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.
- Being tested
- MT1011, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1011Drug
MT1011 is a novel synthetic small molecule anticoagulant reversal agent for reversing anticoagulant effects including factor IIa and Xa inhibitors.
PlaceboDrug
This intervention contains no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| MT1011 | Experimental | Interventional: The SAD study involves single administration of MT1011 Receives: Drug: MT1011 |
| Placebo | Placebo comparator | Placebo: The SAD study involves single administration of Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs).
The occurrence of all adverse events (AEs), serious adverse events (SAEs)
Measured: up to Day 14
Secondary outcomes (12)
Cmax of MT1011
Cmax - Maximum plasma concentration
Measured: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.
Tmax of MT1011
Tmax - Time to reach Cmax
Measured: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.
T1/2 of MT1011
t1/2 - Elimination half-life
Measured: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.
AUC0-tau of MT1011
AUC0-tau - Area under the plasma concentration-time curve during one dosing interval
Measured: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.
AUC0-t of MT1011
AUC0-t - Area under the plasma concentration-time curve from time zero to the last measurable concentration
Measured: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.
Whole blood clotting time
Whole blood clotting time
Measured: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Activated partial thromboplastin time
Activated partial thromboplastin time
Measured: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Prothrombin time
Prothrombin time
Measured: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
fibrinogen
fibrinogen
Measured: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
International normalized ratios
International normalized ratios
Measured: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Thrombin time
Thrombin time
Measured: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Factor Xa activity
Factor Xa activity
Measured: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start25 Jun 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of AnticoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024160
- Sponsor's protocol ID
- MT1011-I-C02
- Status last verified
- May 2025
- First submitted
- 9 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07024160
- Acronym / sponsor ID
- MT1011-I-C02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT1011 | Experimental | Drug: MT1011Interventional: The SAD study involves single administration of MT1011 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: The SAD study involves single administration of Placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT1011MT1011 is a novel synthetic small molecule anticoagulant reversal agent for reversing anticoagulant effects including factor IIa and Xa inhibitors. | Drug | MT1011 |
| PlaceboThis intervention contains no active ingredients | Drug | Placebo |
Primary outcome
Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs).
Time frame: up to Day 14
The occurrence of all adverse events (AEs), serious adverse events (SAEs)
12 secondary outcomes
Cmax of MT1011
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.
Tmax of MT1011
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.
T1/2 of MT1011
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.
AUC0-tau of MT1011
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.
AUC0-t of MT1011
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.
Whole blood clotting time
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Activated partial thromboplastin time
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Prothrombin time
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
fibrinogen
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
International normalized ratios
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Thrombin time
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Factor Xa activity
Time frame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT1011 in people with Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Hua Hao, Ph.D. in Medicine (010-63926883, xiaohualuck@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs). (time frame: up to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.