A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JMT202

NCT06564467 | Enrolling By Invitation Phase 1

• 1 other identifier: JMT202-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• The Number of adverse events (AEs) electrocardiograms

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

  Pre-dose and multiple timepoints no less than 50 days

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

  Pre-dose and multiple timepoints no less than 50 days

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

  Pre-dose and multiple timepoints no less than 50 days

• Number of participants with clinically significant abnormalities in physical examination

  Pre-dose and multiple timepoints no less than 50 days

Secondary Outcomes (12)

• 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

• Area under the concentration-time curve from 0 to infinity (AUC0-∞)

  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

Study Arms (2)

JMT202 SAD experimental group

EXPERIMENTAL

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

Drug: JMT202

Placebo SAD group

PLACEBO COMPARATOR

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

Drug: Placrbo

Interventions

JMT202 DRUG

subcutaneous injection

JMT202 SAD experimental group

Placrbo DRUG

subcutaneous injection

Placebo SAD group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Participants with non-negative test for any of HBsAg, HCV antibodies, syphilis antibodies, and HIV antibodies;
• Blood loss or blood donation of more than 400 mL within 3 months prior to administration;
• Those who underwent major surgery within 6 months prior to initial administration;
• Vaccination was administered within 28 days before the trial or within 1 week after the planned dose;
• Antibody drugs targeting β-Klotho/FGFR1c have been used before screening;

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

Peking University First Hospital

Beijin, China

Location

Study Officials

• Jianping Li, doctor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Drug: JMT202 Other: Placebo

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 21, 2024
• Study Start: July 23, 2024
• Primary Completion: January 10, 2025
• Study Completion: July 10, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-07

Locations

CN (1)