Actively Recruiting
Evaluate the Safety, Tolerability, PK, and PD of JMT206 Injection in Healthy Participants
Led by Shanghai JMT-Bio Inc. · Updated on 2026-02-19
44
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical trial. It aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single administration of JMT206 Injection in healthy participants.
CONDITIONS
Official Title
Evaluate the Safety, Tolerability, PK, and PD of JMT206 Injection in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 60 years (inclusive) at screening, male or female.
- Body weight at least 50.0 kg for males and at least 45.0 kg for females.
- Body mass index (BMI) between 19.0 and 28.0 kg/m2 (inclusive).
- Body weight change less than 5% within 3 months before screening, with consistent diet and exercise habits.
- Normal or clinically non-significant results in vital signs, physical exam, ECG, chest X-ray, ultrasound, and lab tests.
- Both participant and partner agree to use effective contraception or abstinence from consent signing until 6 months after last dose.
- Able to read, understand, and voluntarily sign informed consent and participate in all study procedures.
You will not qualify if you...
- History of allergy to JMT206 or its components.
- History of risk factors for Torsades de pointes, uncorrected low potassium or magnesium, or use of medications that prolong QT interval.
- Current serious illness or history of chronic or severe diseases affecting major organs or systems.
- Known conditions affecting skeletal muscle protein or use of anabolic drugs/supplements within 3 months.
- History of gastrointestinal surgery causing malabsorption or use of drugs affecting gastrointestinal motility or weight within 3 months.
- Use of any prescription, over-the-counter, or Chinese herbal medicines within 4 weeks.
- Alcohol consumption over 14 units per week in last 3 months, or alcohol use within 48 hours before dosing.
- Smoking 5 or more cigarettes per day within 6 months or smoking within 48 hours before dosing.
- Regular consumption of certain fruits or excessive caffeine/xanthine intake affecting drug metabolism within 3 months or 72 hours before dosing.
- History of drug abuse within 6 months or positive drug test.
- Recent blood transfusion, blood loss, or donation exceeding specified limits.
- History of needle or blood phobia affecting blood sampling.
- Specific dietary requirements incompatible with study diet.
- Female participants who are pregnant, breastfeeding, or positive pregnancy test.
- Participation in another clinical trial within 3 months or planning during the study.
- Any other condition judged by investigator as unsuitable for participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BeiJing Cancer Hospital EC
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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