Safety and TolerabilityPhase 1NCT06079541
Phase 1 Clinical Study of JMKX003142 Tablets
A Phase 1 study testing JMKX003142 will be administered orally in people with Safety and Tolerability, run by Jemincare at 1 site in China.
Trial summary
Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of JMKX003142 tablets administered randomly, double-blind, placebo-controlled single and multiple times in healthy adult subjects, as well as the effects of randomized, open, and two cycle crossover foods Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- JMKX003142 will be administered orally
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2023to 30 Mar 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects aged 18-45 years (including boundary values)
- Able to sign a written informed consent form
- Physical examination, clinical laboratory examination value, Virology examination, vital signs and 12 lead ECG examination are confirmed by the researcher to be normal or abnormal without clinical significance
- The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol
Who cannot join
- Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, as well as habitual constipation, gastrointestinal bleeding history, which is judged to be inappropriate for the study by the investigators
- Participants in any other clinical study within 3 months prior to the first administration of this study
- The investigators believe that the subject has other factors that are not suitable for participating in this experiment
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Xuening Li
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Tablets Administered Randomly, Double-blind, Placebo-controlled Single and Multiple Times in Healthy Adult Subjects, as Well as the Effects of Randomized, Open, and Two Cycle Crossover Foods
Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of JMKX003142 tablets administered randomly, double-blind, placebo-controlled single and multiple times in healthy adult subjects, as well as the effects of randomized, open, and two cycle crossover foods
- Conditions
- Safety and Tolerability
- Being tested
- JMKX003142 will be administered orally, Placebo in Cohorts 1 to 7, Placebo in 3 Cohorts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX003142 will be administered orallyDrug
Also called JMKX003142
oral once
JMKX003142 will be administered orallyDrug
Also called JMKX003142
oral once
JMKX003142 will be administered orallyDrug
Also called JMKX003142
oral once
Placebo in Cohorts 1 to 7Drug
Also called Matching placebo will be administered orally
oral once
Placebo in 3 CohortsDrug
Also called Matching placebo will be administered orally
oral once
| Study group | Role | What they receive |
|---|---|---|
| JMKX003142 SAD experimental group | Experimental | Participants will be randomized into 7 cohorts to receive single oral dose of JMKX003142 on Day 1. The doses in each cohort will be escalated based on the safety and pharmacokinetics (PK) / Pharmacodynamics (PD) data of the previous cohort. Receives: Drug: JMKX003142 will be administered orally |
| JMKX003142 MAD experimental group | Experimental | Participants will be randomized into 3 cohorts to receive orally once -daily of JMKX003142 for 7 consecutive days. The second cohort will be escalated based on the safety and pharmacokinetics (PK)/ Pharmacodynamics (PD) data of the previous cohort. Receives: Drug: JMKX003142 will be administered orally |
| JMKX003142 FE experimental group | Experimental | Participants will receive 2 Sequence regimens, with a washout period between treatments. Receives: Drug: JMKX003142 will be administered orally |
| Placebo in Cohorts 1 to 7 | Experimental | Participants in Cohorts 1 to 7 will receive single oral dose of matching placebo on Day 1. Receives: Drug: Placebo in Cohorts 1 to 7 |
| Placebo in 3 Cohorts | Experimental | Participants in 3 Cohorts will receive orally once -daily of matching placebo for 7 consecutive days. Receives: Drug: Placebo in 3 Cohorts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the Adverse Events that are related to the single dose treatment
single dose safety
Measured: from baseline to Day 18
Number of the Adverse Events that are related to the multiple dose treatment from
multiple dose safety
Measured: from baseline to Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start6 Jul 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and TolerabilityStudies of the same condition, open and under way.
- More trials run by JemincareThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Xuening li, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079541
- Sponsor's protocol ID
- JY-JM-035-101
- Status last verified
- Jul 2023
- First submitted
- 6 Oct 2023
- Last updated
- 17 Oct 2023
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Tablets Administered Randomly, Double-blind, Placebo-controlled Single and Multiple Times in Healthy Adult Subjects, as Well as the Effects of Randomized, Open, and Two Cycle Crossover Foods
- ClinicalTrials.gov ID
- NCT06079541
- Acronym / sponsor ID
- JY-JM-035-101
- Conditions
- Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 12 Oct 2023 (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.
Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of JMKX003142 tablets administered randomly, double-blind, placebo-controlled single and multiple times in healthy adult subjects, as well as the effects of randomized, open, and two cycle crossover foods
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| JMKX003142 SAD experimental group | Experimental | Drug: JMKX003142 will be administered orallyParticipants will be randomized into 7 cohorts to receive single oral dose of JMKX003142 on Day 1. The doses in each cohort will be escalated based on the safety and pharmacokinetics (PK) / Pharmacodynamics (PD) data of the previous cohort. |
| JMKX003142 MAD experimental group | Experimental | Drug: JMKX003142 will be administered orallyParticipants will be randomized into 3 cohorts to receive orally once -daily of JMKX003142 for 7 consecutive days. The second cohort will be escalated based on the safety and pharmacokinetics (PK)/ Pharmacodynamics (PD) data of the previous cohort. |
| JMKX003142 FE experimental group | Experimental | Drug: JMKX003142 will be administered orallyParticipants will receive 2 Sequence regimens, with a washout period between treatments. |
| Placebo in Cohorts 1 to 7 | Experimental | Drug: Placebo in Cohorts 1 to 7Participants in Cohorts 1 to 7 will receive single oral dose of matching placebo on Day 1. |
| Placebo in 3 Cohorts | Experimental | Drug: Placebo in 3 CohortsParticipants in 3 Cohorts will receive orally once -daily of matching placebo for 7 consecutive days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female subjects aged 18-45 years (including boundary values)
- Able to sign a written informed consent form
- Physical examination, clinical laboratory examination value, Virology examination, vital signs and 12 lead ECG examination are confirmed by the researcher to be normal or abnormal without clinical significance
- The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol
Key exclusion criteria (4 listed)
- Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, as well as habitual constipation, gastrointestinal bleeding history, which is judged to be inappropriate for the study by the investigators
- Participants in any other clinical study within 3 months prior to the first administration of this study
- The investigators believe that the subject has other factors that are not suitable for participating in this experiment
- Pregnant or lactating women
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 |
|---|---|---|
| JMKX003142 will be administered orallyAlso: JMKX003142oral once | Drug | JMKX003142 SAD experimental group |
| JMKX003142 will be administered orallyAlso: JMKX003142oral once | Drug | JMKX003142 MAD experimental group |
| JMKX003142 will be administered orallyAlso: JMKX003142oral once | Drug | JMKX003142 FE experimental group |
| Placebo in Cohorts 1 to 7Also: Matching placebo will be administered orallyoral once | Drug | Placebo in Cohorts 1 to 7 |
| Placebo in 3 CohortsAlso: Matching placebo will be administered orallyoral once | Drug | Placebo in 3 Cohorts |
Primary outcome
Number of the Adverse Events that are related to the single dose treatment
Time frame: from baseline to Day 18
single dose safety
Number of the Adverse Events that are related to the multiple dose treatment from
Time frame: from baseline to Day 24
multiple dose safety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
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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.
Xuening li principal investigator
Fudan University
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 JMKX003142 will be administered orally in people with Safety and Tolerability, run by Jemincare 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 4 inclusion and 4 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 17 Oct 2023. 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. 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?
Contact jianping Su (+86 15162481262, sujianping@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of the Adverse Events that are related to the single dose treatment (time frame: from baseline to Day 18). The study lists 2 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 17 Oct 2023.