Phase I Study of MT1011 Injection in Healthy Subjects

NCT07024160 | Recruiting Phase 1

• 1 other identifier: MT1011-I-C02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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)

  up to Day 14

Secondary Outcomes (12)

• 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.

• 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.

• 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.

• 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-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.

Study Arms (2)

MT1011

EXPERIMENTAL

Interventional: The SAD study involves single administration of MT1011

Drug: MT1011

Placebo

PLACEBO COMPARATOR

Placebo: The SAD study involves single administration of Placebo.

Drug: Placebo

Interventions

MT1011 DRUG

MT1011 is a novel synthetic small molecule anticoagulant reversal agent for reversing anticoagulant effects including factor IIa and Xa inhibitors.

MT1011

Placebo DRUG

This intervention contains no active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaanxi Micot Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100038, China

RECRUITING

Central Study Contacts

Xiao Hua Hao, Ph.D. in Medicine

CONTACT

010-63926883; xiaohualuck@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: June 25, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-05

Locations

CN (1)