ClinicalTrials.gg
RecruitingNCT07419698Updated Feb 19, 2026

Evaluate the Safety, Tolerability, PK, and PD of JMT206 Injection in Healthy Participants

A Phase 1 interventional study of JMT206 and Placebo in Healthy Participants, sponsored by Shanghai JMT-Bio Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Shanghai JMT-Bio Inc. (part of CSPC Pharmaceutical Group Limited) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Shanghai JMT-Bio Inc. is the lead sponsor of 42 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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 (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 .
  5. Both the participant and their partner agree to use a method with a ≤1% annual failure rate or maintain abstinence from signing the 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

Exclusion Criteria:

  1. Participants with a history of or known/suspected allergy to JMT206 or any component of the product.
  2. Participants with a history of risk factors for Torsades de pointes (TdP) (e.g., heart failure/cardiomyopathy or family history of long 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 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, , 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 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
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    JMT206

    Biological: JMT206

  • Placebo comparator
    Placebo group

    Drug: Placebo

Interventions

  • BiologicalJMT206

    Subcutaneous injection, single dose.

  • DrugPlacebo

    Subcutaneous injection, single dose.

06

What researchers measure

Primary outcomes

  1. Incidence of AE Description

    Time frame: Up to Day 64

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Sep 2026, 7 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2026
First posted
Feb 19, 2026
StartActual
Jan 26, 2026
Primary completionEst.
Sep 1, 2026
CompletionEst.
Nov 1, 2026
Last update
Feb 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07419698
Responsible party
Sponsor
First posted
Feb 19, 2026
Start date
Jan 26, 2026
Primary completion
Sep 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Feb 19, 2026

Study contacts

Clinical Trials Information Group officer
Contact
ctr-contact@cspc.cn
0311-69085587

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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