Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation
Conditions
Brief 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.
Interventions
DRUGMT1011
MT1011 is a novel synthetic small molecule anticoagulant reversal agent for reversing anticoagulant effects including factor IIa and Xa inhibitors.
DRUGPlacebo
This intervention contains no active ingredients
Sponsors
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs). | up to Day 14 | The occurrence of all adverse events (AEs), serious adverse events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of MT1011 | 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. | Cmax - Maximum plasma concentration |
| Tmax of MT1011 | 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 - Time to reach Cmax |
| T1/2 of MT1011 | 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 - Elimination half-life |
| AUC0-tau of MT1011 | 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 - Area under the plasma concentration-time curve during one dosing interval |
| AUC0-t of MT1011 | 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 - Area under the plasma concentration-time curve from time zero to the last measurable concentration |
| Thrombin time | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. | Thrombin time |
| Activated partial thromboplastin time | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. | Activated partial thromboplastin time |
| Prothrombin time | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. | Prothrombin time |
| fibrinogen | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. | fibrinogen |
| International normalized ratios | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. | International normalized ratios |
| Factor Xa activity | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. | Factor Xa activity |
| Whole blood clotting time | Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose. | Whole blood clotting time |
Countries
China
Contacts
Primary ContactXiao Hua Hao, Ph.D. in Medicine
Outcome results
None listed