Phase I Study of MT1011 Injection in Healthy Subjects

Phase 1RecruitingNCT07024160

Shaanxi Micot Pharmaceutical Technology Co., Ltd.40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: up to Day 14