Evaluate the Safety, Tolerability, PK, and PD of JMT206 Injection in Healthy Participants
ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai JMT-Bio Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Aged 18 to 60 years (inclusive) at screening, male or female.
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/m² (inclusive).
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%.
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.
Disqualifiers
Participants with a history of hypersensitivity or known/suspected allergy to JMT206 or any component of the investigational product.
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.
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.
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.
Trial design
Treatments tested in this trial
- JMT206
- Placebo
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov