Clinical trial NCT07024160: Phase I Study of MT1011 Injection in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation
Lead sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs).
timeFrame: up to Day 14
Secondary outcomes:
measure: Cmax of MT1011
timeFrame: 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.
measure: Tmax of MT1011
timeFrame: 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.
measure: T1/2 of MT1011
timeFrame: 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.
measure: AUC0-tau of MT1011
timeFrame: 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.
measure: AUC0-t of MT1011
timeFrame: 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.
measure: Whole blood clotting time
timeFrame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
measure: Activated partial thromboplastin time
timeFrame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
measure: Prothrombin time
timeFrame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
measure: fibrinogen
timeFrame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
measure: International normalized ratios
timeFrame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
measure: Thrombin time
timeFrame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
measure: Factor Xa activity
timeFrame: Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital, Capital Medical University
state: Beijing
Study officials:
References: