Clinical Trials/NCT06564467

NCT06564467

Enrolling By Invitation

Phase 1

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

Shanghai JMT-Bio Inc.1 site in 1 country54 target enrollmentJuly 23, 2024

ConditionsHealthy Subjects

InterventionsJMT202 Placrbo

DrugsJMT202 Placrbo

Overview

Phase: Phase 1
Intervention: JMT202
Conditions: Healthy Subjects
Sponsor: Shanghai JMT-Bio Inc.
Enrollment: 54
Locations: 1
Primary Endpoint: Number of participants with clinically significant change from baseline in vital signs
Status: Enrolling By Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 23, 2024

End Date

July 10, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai JMT-Bio Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age of 18 - 60 years (inclusive), male or female;
•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;
•Normal vital signs; Normal physical examination; Normal ECG findings; Normal laboratory examination; Normal imaging examination (X-ray);
•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;
•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

•Allergic constitution or known history of allergy to the components of the study drug or similar drugs；
•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;
•Participants with a history of cancer, mental illness, depression, anxiety, and epilepsy;
•With diabetes, thyroid dysfunction or have other affect blood glucose metabolic endocrine disease;
•HbA1c \>6.5% at screening;
•AST or ALT\>1.5 times the upper limit of normal at screening;
•Fasting triglycerides\>1.7 mmol/L at screening;
•The estimated glomerular filtration rate (eGFR) during screening was \< 90 mL/min/1.73 m\^2 (calculated by simplified MDRD formula);
•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；
•During screening, participants with prolonged QT/QTc interval (QTcF \> 450 ms in male, \> 470 ms in female);

Arms & Interventions

JMT202 SAD experimental group

Participants in SAD experimental groups will receive a single subcutaneous injection of JMT202 on Day 1.

Intervention: JMT202

Placebo SAD group

Participants in SAD experimental groups will receive a single subcutaneous injection of placebo on Day 1.

Intervention: Placrbo

Outcomes

Primary Outcomes

Number of participants with clinically significant change from baseline in vital signs

Time Frame: Pre-dose and multiple timepoints no less than 50 days

The Number of adverse events (AEs) electrocardiograms

Time Frame: Pre-dose and multiple timepoints no less than 50 days

To investigate the safety and tolerability by assesment of AEs following administration.

Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings

Time Frame: Pre-dose and multiple timepoints no less than 50 days

Number of participants with clinically significant abnormalities in physical examination

Time Frame: Pre-dose and multiple timepoints no less than 50 days

Secondary Outcomes

Absolute change in fasting insulin level(Pre-dose and multiple timepoints no less than 50 days)
Area under the concentration-time curve from 0 to the collection time t (AUC0-t)(Pre-dose and multiple timepoints no less than 50 days)
Time to maximum concentration (Tmax)(Pre-dose and multiple timepoints no less than 50 days)
Serum Maximum concentration (Cmax)(Pre-dose and multiple timepoints no less than 50 days)
Half-Life (t1/2)(Pre-dose and multiple timepoints no less than 50 days)
Anti-drug antibody (ADA) prevalence in blood before study treatment and at the Follow-up Visit(Pre-dose and multiple timepoints no less than 50 days)
Area under the concentration-time curve from 0 to infinity (AUC0-∞)(Pre-dose and multiple timepoints no less than 50 days)
Absolute change in High molecular weight adiponectin(Pre-dose and multiple timepoints no less than 50 days)
Absolute change in weight(Pre-dose and multiple timepoints no less than 50 days)
Absolute change in glycosylated hemoglobin(Pre-dose and multiple timepoints no less than 50 days)
Absolute change in blood lipoprotein(Pre-dose and multiple timepoints no less than 50 days)
Absolute change in fasting glucose(Pre-dose and multiple timepoints no less than 50 days)