Healthy SubjectsPhase 1NCT06564467
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JMT202
A Phase 1 study testing JMT202 and Placrbo in people with Healthy Subjects, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- JMT202 and Placrbo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2024to 10 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- Participated in another study within 3 months before administration; Or plans to participate in another drug trial during the study
- Those who have any special diet requirements, cannot accept unified diet and schedule；
- 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;
- 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；
- 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;
- A history of drug abuse, and/or drug use within 3 months prior to screening, and/or positive urine drug screening;
- There were symptoms such as dermatitis or skin abnormalities in and around the site of administration;
- Participants who were dizzy with needles, dizzy with blood, unable to tolerate blood collection by venipuncture, or with poor peripheral venous access conditions;
- 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;
- The researchers think doesn't fit to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- JMT202, Placrbo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT202Drug
subcutaneous injection
PlacrboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| JMT202 SAD experimental group | Experimental | Participants in SAD experimental groups will receive a single subcutaneous injection of JMT202 on Day 1. Receives: Drug: JMT202 |
| Placebo SAD group | Placebo comparator | Participants in SAD experimental groups will receive a single subcutaneous injection of placebo on Day 1. Receives: Drug: Placrbo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of adverse events (AEs) electrocardiograms
To investigate the safety and tolerability by assesment of AEs following administration.
Measured: Pre-dose and multiple timepoints no less than 50 days
Number of participants with clinically significant change from baseline in vital signs
Measured: Pre-dose and multiple timepoints no less than 50 days
Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings
Measured: Pre-dose and multiple timepoints no less than 50 days
Number of participants with clinically significant abnormalities in physical examination
Measured: 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)
Measured: Pre-dose and multiple timepoints no less than 50 days
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
Measured: Pre-dose and multiple timepoints no less than 50 days
Time to maximum concentration (Tmax)
Measured: Pre-dose and multiple timepoints no less than 50 days
Serum Maximum concentration (Cmax)
Measured: Pre-dose and multiple timepoints no less than 50 days
Half-Life (t1/2)
Measured: 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
Measured: Pre-dose and multiple timepoints no less than 50 days
Absolute change in High molecular weight adiponectin
Measured: Pre-dose and multiple timepoints no less than 50 days
Absolute change in weight
Measured: Pre-dose and multiple timepoints no less than 50 days
Absolute change in glycosylated hemoglobin
Measured: Pre-dose and multiple timepoints no less than 50 days
Absolute change in fasting insulin level
Measured: Pre-dose and multiple timepoints no less than 50 days
Absolute change in fasting glucose
Measured: Pre-dose and multiple timepoints no less than 50 days
Absolute change in blood lipoprotein
Measured: Pre-dose and multiple timepoints no less than 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start23 Jul 2024
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug: JMT202 Other: Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianping Li, doctor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564467
- Sponsor's protocol ID
- JMT202-001
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06564467
- Acronym / sponsor ID
- JMT202-001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Drug: JMT202 Other: Placebo
| Arm | Type | Receives |
|---|---|---|
| JMT202 SAD experimental group | Experimental | Drug: JMT202Participants in SAD experimental groups will receive a single subcutaneous injection of JMT202 on Day 1. |
| Placebo SAD group | Placebo comparator | Drug: PlacrboParticipants in SAD experimental groups will receive a single subcutaneous injection of placebo on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMT202subcutaneous injection | Drug | JMT202 SAD experimental group |
| Placrbosubcutaneous injection | Drug | Placebo SAD group |
Primary outcome
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 vital signs
Time frame: Pre-dose and multiple timepoints no less than 50 days
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
12 secondary outcomes
Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
Time frame: Pre-dose and multiple timepoints no less than 50 days
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
Time frame: Pre-dose and multiple timepoints no less than 50 days
Time to maximum concentration (Tmax)
Time frame: Pre-dose and multiple timepoints no less than 50 days
Serum Maximum concentration (Cmax)
Time frame: Pre-dose and multiple timepoints no less than 50 days
Half-Life (t1/2)
Time frame: 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
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in High molecular weight adiponectin
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in weight
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in glycosylated hemoglobin
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in fasting insulin level
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in fasting glucose
Time frame: Pre-dose and multiple timepoints no less than 50 days
Absolute change in blood lipoprotein
Time frame: Pre-dose and multiple timepoints no less than 50 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianping Li, doctor principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMT202 and Placrbo in people with Healthy Subjects, run by Shanghai JMT-Bio Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of adverse events (AEs) electrocardiograms (time frame: Pre-dose and multiple timepoints no less than 50 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.