Phase I Study of MT1011 Injection in Healthy Subjects

Phase 1

Recruiting

• Conditions: Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation
• Interventions: Drug: MT1011; Drug: Placebo

• Registration Number: NCT07024160
• Lead Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Study First Posted: 2025-06-17
• Study Start: 2025-06-25
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-03
• Primary Completion: 2026-04
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MT1011	MT1011	Interventional: The SAD study involves single administration of MT1011
Placebo	Placebo	Placebo: The SAD study involves single administration of Placebo.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
Thrombin time	Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.	Thrombin time
Factor Xa activity	Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.	Factor Xa activity
International normalized ratios	Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.	International normalized ratios

Trial Locations

Locations (1)

Beijing Shijitan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China