A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JMT202
- Conditions
- Healthy Subjects
- Registration Number
- NCT06564467
- Lead Sponsor
- Shanghai JMT-Bio Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age of 18 - 60 years (inclusive), male or female;<br><br> 2. BMI: 18.0-26.0 kg/m^2 (inclusive), with a minimum weight of 50.0 kg (inclusive) for<br> male and 45.0 kg (inclusive) for female;<br><br> 3. Normal vital signs; Normal physical examination; Normal ECG findings; Normal<br> laboratory examination; Normal imaging examination (X-ray);<br><br> 4. Participants and their partners agree to use effective and reliable contraceptive<br> methods to avoid pregnancy, and male subjects had no plans to donate sperm, and<br> female subjects had no plans to donate eggs, from the time they signed the informed<br> consent to 6 months after the end of the study;<br><br> 5. Participants must give informed consent before the trial, fully understand the<br> content, procedures and possible adverse reactions, and voluntarily sign a written<br> informed consent.<br><br>Exclusion Criteria:<br><br> 1. Allergic constitution or known history of allergy to the components of the study<br> drug or similar drugs;<br><br> 2. Participants with a history of serious diseases, including pancreas, cardiovascular,<br> liver, kidney, blood and lymphatic, central nervous system, and gastrointestinal<br> systems, or other important diseases that may affect the absorption, metabolism, or<br> excretion of the study drug;<br><br> 3. Participants with a history of cancer, mental illness, depression, anxiety, and<br> epilepsy;<br><br> 4. With diabetes, thyroid dysfunction or have other affect blood glucose metabolic<br> endocrine disease;<br><br> 5. HbA1c >6.5% at screening;<br><br> 6. AST or ALT>1.5 times the upper limit of normal at screening;<br><br> 7. Fasting triglycerides>1.7 mmol/L at screening;<br><br> 8. The estimated glomerular filtration rate (eGFR) during screening was < 90<br> mL/min/1.73 m^2 (calculated by simplified MDRD formula);<br><br> 9. Screening, vital signs has one or more check exception: temperature < 35.5 ? or ><br> 37.2 ?, pulse < 60 times/min or > 100 times/min, systolic blood pressure = 140 mmHg<br> or < 90 mmHg, diastolic blood pressure = 90 mmHg or < 60 mmHg;<br><br> 10. During screening, participants with prolonged QT/QTc interval (QTcF > 450 ms in<br> male, > 470 ms in female);<br><br> 11. Participants with non-negative test for any of HBsAg, HCV antibodies, syphilis<br> antibodies, and HIV antibodies;<br><br> 12. Blood loss or blood donation of more than 400 mL within 3 months prior to<br> administration;<br><br> 13. Those who underwent major surgery within 6 months prior to initial administration;<br><br> 14. Vaccination was administered within 28 days before the trial or within 1 week after<br> the planned dose;<br><br> 15. Antibody drugs targeting ß-Klotho/FGFR1c have been used before screening;<br><br> 16. Use of any drug for therapeutic purposes within 2 weeks prior to administration or<br> within the 5 half-lives of the drug (whichever is longer), including prescription<br> drugs, over-the-counter drugs or health care products, Chinese herbs;<br><br> 17. Participated in another study within 3 months before administration; Or plans to<br> participate in another drug trial during the study<br><br> 18. Those who have any special diet requirements, cannot accept unified diet and<br> schedule;<br><br> 19. Those who smoked more than 5 cigarettes per day within 3 months prior to screening<br> and/or did not agree to refrain from using any tobacco products during the study;<br><br> 20. Regular drinkers within 3 months prior to screening, female more than 14 g (i.e.,145<br> mL wine, 497 mL beer or 44 mL low-alcohol liquor), male more than 28 g (i.e.,290 mL<br> wine, 994 mL beer or 88 mL low-alcohol liquor), or within 48 h before administration<br> taking any alcohol, and/or test positive for breath alcohol;<br><br> 21. Regular drinkers within 1 months prior to screening, i.e., those who consume<br> excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1<br> cup = 250 mL) per day, and/or do not agree that tea, coffee and/or caffeinated<br> foods, grapefruit and/or grapefruit juice, and/or products containing opium poppy<br> are prohibited during the study;<br><br> 22. A history of drug abuse, and/or drug use within 3 months prior to screening, and/or<br> positive urine drug screening;<br><br> 23. There were symptoms such as dermatitis or skin abnormalities in and around the site<br> of administration;<br><br> 24. Participants who were dizzy with needles, dizzy with blood, unable to tolerate blood<br> collection by venipuncture, or with poor peripheral venous access conditions;<br><br> 25. Pregnant or lactating women; blood HCG positive, and/or women of childbearing age<br> who have unprotected sex with their partner within 30 days before screening;<br><br> 26. The researchers think doesn't fit to participate in this study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Number of adverse events (AEs) electrocardiograms;Number of participants with clinically significant change from baseline in vital signs;Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings;Number of participants with clinically significant abnormalities in physical examination
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve from 0 to the collection time t (AUC0-t);Area under the concentration-time curve from 0 to infinity (AUC0-8);Time to maximum concentration (Tmax);Serum Maximum concentration (Cmax);Half-Life (t1/2);Anti-drug antibody (ADA) prevalence in blood before study treatment and at the Follow-up Visit;Absolute change in High molecular weight adiponectin;Absolute change in weight;Absolute change in glycosylated hemoglobin;Absolute change in fasting insulin level;Absolute change in fasting glucose;Absolute change in blood lipoprotein