Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase I Study of MT1011 Injection in Healthy Subjects
Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd.
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.
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
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-06-25
Completion Date
2026-04
Last Updated
2025-07-03
Healthy Volunteers
Yes
Interventions
MT1011
MT1011 is a novel synthetic small molecule anticoagulant reversal agent for reversing anticoagulant effects including factor IIa and Xa inhibitors.
Placebo
This intervention contains no active ingredients
Locations (1)
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China