Clinical trial NCT06564467: A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JMT202
Official title: A Phase І, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMT202 Injection in Chinese Healthy Participants
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Drug: JMT202 Other: Placebo
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JMT202 in Healthy Participants.


Eligibility criteria: Inclusion Criteria:

1. Age of 18 - 60 years (inclusive), male or female;
2. BMI: 18.0-26.0 kg/m\^2 (inclusive), with a minimum weight of 50.0 kg (inclusive) for male and 45.0 kg (inclusive) for female;
3. Normal vital signs; Normal physical examination; Normal ECG findings; Normal laboratory examination; Normal imaging examination (X-ray);
4. Participants and their partners agree to use effective and reliable contraceptive methods to avoid pregnancy, and male subjects had no plans to donate sperm, and female subjects had no plans to donate eggs, from the time they signed the informed consent to 6 months after the end of the study;
5. Participants must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent.

Exclusion Criteria:

1. Allergic constitution or known history of allergy to the components of the study drug or similar drugs；
2. Participants with a history of serious diseases, including pancreas, cardiovascular, liver, kidney, blood and lymphatic, central nervous system, and gastrointestinal systems, or other important diseases that may affect the absorption, metabolism, or excretion of the study drug;
3. Participants with a history of cancer, mental illness, depression, anxiety, and epilepsy;
4. With diabetes, thyroid dysfunction or have other affect blood glucose metabolic endocrine disease;
5. HbA1c \>6.5% at screening;
6. AST or ALT\>1.5 times the upper limit of normal at screening;
7. Fasting triglycerides\>1.7 mmol/L at screening;
8. The estimated glomerular filtration rate (eGFR) during screening was \< 90 mL/min/1.73 m\^2 (calculated by simplified MDRD formula);
9. Screening, vital signs has one or more check exception: temperature \< 35.5 ℃ or \> 37.2 ℃, pulse \< 60 times/min or \> 100 times/min, systolic blood pressure ≥ 140 mmHg or \< 90 mmHg, diastolic blood pressure ≥ 90 mmHg or \< 60 mmHg；
10. During screening, participants with prolonged QT/QTc interval (QTcF \> 450 ms in male, \> 470 ms in female);
11. Participants with non-negative test for any of HBsAg, HCV antibodies, syphilis antibodies, and HIV antibodies;
12. Blood loss or blood donation of more than 400 mL within 3 months prior to administration;
13. Those who underwent major surgery within 6 months prior to initial administration;
14. Vaccination was administered within 28 days before the trial or within 1 week after the planned dose;
15. Antibody drugs targeting β-Klotho/FGFR1c have been used before screening;
16. Use of any drug for therapeutic purposes within 2 weeks prior to administration or within the 5 half-lives of the drug (whichever is longer), including prescription drugs, over-the-counter drugs or health care products, Chinese herbs;
17. Participated in another study within 3 months before administration; Or plans to participate in another drug trial during the study
18. Those who have any special diet requirements, cannot accept unified diet and schedule；
19. Those who smoked more than 5 cigarettes per day within 3 months prior to screening and/or did not agree to refrain from using any tobacco products during the study;
20. Regular drinkers within 3 months prior to screening, female more than 14 g (i.e.,145 mL wine, 497 mL beer or 44 mL low-alcohol liquor), male more than 28 g (i.e.,290 mL wine, 994 mL beer or 88 mL low-alcohol liquor), or within 48 h before administration taking any alcohol, and/or test positive for breath alcohol；
21. Regular drinkers within 1 months prior to screening, i.e., those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day, and/or do not agree that tea, coffee and/or caffeinated foods, grapefruit and/or grapefruit juice, and/or products containing opium poppy are prohibited during the study;
22. A history of drug abuse, and/or drug use within 3 months prior to screening, and/or positive urine drug screening;
23. There were symptoms such as dermatitis or skin abnormalities in and around the site of administration;
24. Participants who were dizzy with needles, dizzy with blood, unable to tolerate blood collection by venipuncture, or with poor peripheral venous access conditions;
25. Pregnant or lactating women; blood HCG positive, and/or women of childbearing age who have unprotected sex with their partner within 30 days before screening;
26. The researchers think doesn't fit to participate in this study.

Primary outcomes:
measure: The Number of adverse events (AEs) electrocardiograms
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Number of participants with clinically significant change from baseline in vital signs
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Number of participants with clinically significant abnormalities in physical examination
timeFrame: Pre-dose and multiple timepoints no less than 50 days
Secondary outcomes:
measure: Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Area under the concentration-time curve from 0 to infinity (AUC0-∞)
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Time to maximum concentration (Tmax)
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Serum Maximum concentration (Cmax)
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Half-Life (t1/2)
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Anti-drug antibody (ADA) prevalence in blood before study treatment and at the Follow-up Visit
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Absolute change in High molecular weight adiponectin
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Absolute change in weight
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Absolute change in glycosylated hemoglobin
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Absolute change in fasting insulin level
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Absolute change in fasting glucose
timeFrame: Pre-dose and multiple timepoints no less than 50 days
measure: Absolute change in blood lipoprotein
timeFrame: Pre-dose and multiple timepoints no less than 50 days
Other outcomes:
Locations:
city: Beijin
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Peking University First Hospital
name: Jianping Li, doctor
role: PRINCIPAL_INVESTIGATOR
References: