Actively Recruiting
Phase I Study of MT1011 Injection in Healthy Subjects
Led by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Updated on 2025-07-03
40
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase I Study of MT1011 Injection in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female subjects aged 18 to 45 years at screening
- Body weight at least 50.0 kg for males and at least 45.0 kg for females
- Body Mass Index (BMI) between 18.5 and 26.0 kg/m² (inclusive)
- Able to provide informed consent and communicate well with investigators
You will not qualify if you...
- Abnormal or clinically significant findings in vital signs, physical exam, lab tests, abdominal ultrasound, or chest X-ray
- Women who are pregnant, breastfeeding, or have a positive pregnancy test
- Subjects or their partners planning pregnancy or sperm/ova donation during or shortly after the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100038
Actively Recruiting
Research Team
X
Xiao Hua Hao, Ph.D. in Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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