Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 60

Safety and body-response testing of JMT206 injection in healthy adults

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMT206 Injection in Healthy Subjects

Run by Shanghai JMT-Bio Inc. · NCT07419698 · Data updated 2026-11-12

This will test a single dose of JMT206 injection in healthy adults to see how safe it is and how the body processes and responds to it.

More Healthy Adult Participants trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment44 (estimated)
SponsorShanghai JMT-Bio Inc.
Industry-sponsored
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJanuary 26, 2026
Main results expectedSeptember 1, 2026
Study endsNovember 1, 2026
Registry record updatedFebruary 19, 2026
Trial IDNCT07419698 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy adults aged 18–60 with stable weight, a BMI of 19.0–28.0 kg/m2, and normal screening examinations are the intended participants.

Probably not a fit

People with active medical conditions, abnormal screening tests, or those outside the specified age, weight, or BMI ranges are unlikely to gain direct health benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized, double-blind, placebo-controlled, dose-escalation Phase 1 trial gives a single administration of JMT206 to healthy adult volunteers and compares results to placebo. Participants are enrolled in ascending dose cohorts with close monitoring for safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). Safety assessments include vital signs, ECG, chest X-ray, abdominal/urinary/gynaecologic ultrasound, and a comprehensive panel of laboratory tests. The design uses blinding and randomization to help distinguish true drug effects from placebo and to identify any dose-limiting tolerability issues.

Why it matters

Potential benefit: If JMT206 shows acceptable safety and predictable PK/PD, it could advance to patient studies and potentially lead to a new therapeutic option in the future.

How similar studies have gone: Dose-escalation PK/PD studies in healthy volunteers are a standard early step and have successfully characterized safety and dosing for many drugs, though they do not demonstrate patient efficacy.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Aged 18 to 60 years (inclusive) at screening, male or female.
2. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening, with a body mass index (BMI) ranging from 19.0 to 28.0 kg/m\^2 (inclusive).
3. Body weight change \< 5% within 3 months prior to screening, and consistent diet and exercise habits maintained from screening until prior to dosing (based on participants's statement). Calculation formula: (Body weight at 12 weeks prior to screening - Body weight at screening) / Body weight at screening \* 100%.
4. Results of examinations such as vital signs, physical examination, 12-lead electrocardiogram (ECG), posteroanterior chest X-ray, B-ultrasound (abdomen, urinary system, gynecological (female only)), and clinical laboratory tests (including but not limited to complete blood count, urinalysis, blood biochemistry, coagulation function, serum virology, thyroid function, tumor marker tests, etc.) are within normal ranges or assessed by the investigator as abnormal but not clinically significant.
5. Both the participant and their partner agree to use a contraceptive method with a ≤1% annual failure rate or maintain abstinence from signing the informed consent form until 6 months after the last dose. Male participants have no plan to donate sperm from signing the informed consent until 6 months after the last dose; female participants have no plan to donate ova from signing the informed consent until 6 months after the last dose.
6. Able to read, understand, and provide written informed consent for the study-related information. Have a full understanding of the trial content, procedures, and potential adverse reactions. Voluntarily sign the informed consent form prior to the trial and ensure personal participation in all study procedures.

Exclusion Criteria:

1. Participants with a history of hypersensitivity or known/suspected allergy to JMT206 or any component of the investigational product.
2. Participants with a history of risk factors for Torsades de pointes (TdP) (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), uncorrected hypokalemia or hypomagnesemia (one retest allowed per investigator's judgment), or currently taking concomitant medications known to prolong the QT/QTc interval.
3. Participants with a current clinically significant illness, or history of chronic or severe diseases. This includes, but is not limited to, diseases of the circulatory, lymphatic, respiratory, endocrine, urinary, digestive, nervous or psychiatric systems, infections, malignancies, severe trauma, or any other condition that the investigator considers grounds for exclusion or may interfere with the interpretation of the study results.
4. Participants with known concomitant conditions that affect skeletal muscle protein, or use of any form of skeletal muscle anabolic drugs or supplements within 3 months prior to screening.
5. Participants with a history of gastrointestinal surgery resulting in malabsorption, or long-term use of drugs that directly affect gastrointestinal motility. Examples include: prior bariatric surgery or procedures (e.g., gastric banding); use of medications or products deemed by the investigator to cause weight changes and affect weight assessment within 3 months prior to dosing; or intention to use weight-loss medications during the study period.
6. Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 4 weeks prior to screening.
7. Average alcohol consumption exceeding 14 units per week within 3 months prior to screening (1 unit = 285 mL of beer, 25 mL of spirits, or 150 mL of wine), or consumption of any alcohol-containing products within 48 hours prior to investigational product administration, or a positive alcohol breath test, or inability to abstain from alcohol during the trial.
8. Smoking ≥5 cigarettes per day within 6 months prior to screening, or smoking within 48 hours prior to investigational product administration, or inability to discontinue use of any tobacco products during the trial.
9. Habitual consumption within 3 months prior to screening, or ingestion within 72 hours prior to investigational product administration, of pitaya (dragon fruit), mango, pomelo, carambola (star fruit), or foods/beverages prepared from them; or excessive intake of foods/beverages containing xanthine or caffeine, or other items known to affect drug absorption, distribution, metabolism, or excretion. Examples include: coffee (\>1100 mL/day), tea (\>2200 mL/day), cola (\>2200 mL/day), energy drinks (\>1100 mL/day), chocolate (\>510 g/day).
10. History of drug abuse within 6 months prior to screening, or a positive drug abuse screening test.
11. Transfusion, blood loss, or blood donation exceeding 400 mL within 3 months prior to dosing (excluding menstrual blood loss in females), and/or platelet donation within 2 weeks prior to dosing.
12. History of needle or blood phobia (vasovagal syncope related to needles or blood), difficult blood sampling, or intolerance to venipuncture.
13. Participants with specific dietary requirements who cannot comply with the standardized diet and schedule.
14. Female participants who are pregnant, lactating, or have a positive pregnancy test at screening.
15. Participation in any drug or medical device clinical trial within 3 months prior to screening, or planning to participate in another clinical trial during the study period.
16. Any other condition or circumstance that, in the investigator's judgment, renders the participant unsuitable for participation in the study

Where it's running

  • BeiJing Cancer Hospital EC
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.