Safety and TolerabilityPhase 1NCT05907382
Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy Subjects
A Phase 1 study testing JMKX003002 will be administered orally in people with Safety and Tolerability, run by Jemincare at 1 site in China.
Trial summary
Safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002 in single and multiple ascending dose randomized，doubled-blind phase 1 study in healthy subjects 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?
- JMKX003002 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
- 80 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2023to Mar 2024
- 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 or female subjects aged 18-45 years (inclusive);-
- With normal or abnormal but clinically insignificant comprehensive physical examination (vital signs, physical examination), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function test) and, 12-lead ECG;
- Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form.
Who cannot join
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial
- Subjects with history of or current malignancy;
- Participant who the researchers believe that there are volunteers who are not suitable for
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality
Jing Zhang
About this study
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003002 in Single and Multiple Ascending Dose Randomized，Doubled-blind Phase 1 Study in Healthy Subjects
Safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002 in single and multiple ascending dose randomized，doubled-blind phase 1 study in healthy subjects
Read the detailed description
Pharmacokinetic (PK) parameters, Pharmacodynamics
- Conditions
- Safety and Tolerability
- Being tested
- JMKX003002 will be administered orally, Placebo in Cohorts 1 to 5, Placebo in 2 Cohorts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX003002 will be administered orallyDrug
Also called JMKX003002
oral once
JMKX003002 will be administered orallyDrug
Also called JMKX003002
oral once
JMKX003002 will be administered orallyDrug
Also called JMKX003002
oral once
Placebo in Cohorts 1 to 5Drug
Also called Matching placebo will be administered orally
oral once
Placebo in 2 CohortsDrug
Also called Matching placebo will be administered orally
oral once
| Study group | Role | What they receive |
|---|---|---|
| JMKX003002 SAD experimental group | Experimental | Participants will be randomized into 5 cohorts to receive single oral dose of JMKX003002 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: JMKX003002 will be administered orally |
| JMKX003002 MAD experimental group | Experimental | Participants will be randomized into 2 cohorts to receive orally twice -daily of JMKX003002 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: JMKX003002 will be administered orally |
| JMKX003002 FE experimental group | Experimental | Participants will receive 3 Sequence regimens, with a washout period between treatments. Receives: Drug: JMKX003002 will be administered orally |
| Placebo in Cohorts 1 to 5 | Placebo comparator | Participants in Cohorts 1 to 5 will receive single oral dose of matching placebo on Day 1. Receives: Drug: Placebo in Cohorts 1 to 5 |
| Placebo in 2 Cohorts | Placebo comparator | Participants in 2 Cohorts will receive orally twice -daily of matching placebo for 7 consecutive days. Receives: Drug: Placebo in 2 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 11
Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18
multiple dose safety
Measured: from baseline to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start9 May 2023
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907382
- Sponsor's protocol ID
- JY-JM3002-101
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003002 in Single and Multiple Ascending Dose Randomized，Doubled-blind Phase 1 Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05907382
- Acronym / sponsor ID
- JY-JM3002-101
- Conditions
- Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 9 May 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 18 Jun 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.
Safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002 in single and multiple ascending dose randomized，doubled-blind phase 1 study in healthy subjects
Detailed description
Pharmacokinetic (PK) parameters, Pharmacodynamics
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 |
|---|---|---|
| JMKX003002 SAD experimental group | Experimental | Drug: JMKX003002 will be administered orallyParticipants will be randomized into 5 cohorts to receive single oral dose of JMKX003002 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. |
| JMKX003002 MAD experimental group | Experimental | Drug: JMKX003002 will be administered orallyParticipants will be randomized into 2 cohorts to receive orally twice -daily of JMKX003002 for 7 consecutive days. The second cohort will be escalated based on the safety and pharmacokinetics (PK)/ Pharmacodynamics (PD) data of the previous cohort. |
| JMKX003002 FE experimental group | Experimental | Drug: JMKX003002 will be administered orallyParticipants will receive 3 Sequence regimens, with a washout period between treatments. |
| Placebo in Cohorts 1 to 5 | Placebo comparator | Drug: Placebo in Cohorts 1 to 5Participants in Cohorts 1 to 5 will receive single oral dose of matching placebo on Day 1. |
| Placebo in 2 Cohorts | Placebo comparator | Drug: Placebo in 2 CohortsParticipants in 2 Cohorts will receive orally twice -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 (3 listed)
- Male or female subjects aged 18-45 years (inclusive);-
- With normal or abnormal but clinically insignificant comprehensive physical examination (vital signs, physical examination), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function test) and, 12-lead ECG;
- Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form.
Key exclusion criteria (3 listed)
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial
- Subjects with history of or current malignancy;
- Participant who the researchers believe that there are volunteers who are not suitable for
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 |
|---|---|---|
| JMKX003002 will be administered orallyAlso: JMKX003002oral once | Drug | JMKX003002 SAD experimental group |
| JMKX003002 will be administered orallyAlso: JMKX003002oral once | Drug | JMKX003002 MAD experimental group |
| JMKX003002 will be administered orallyAlso: JMKX003002oral once | Drug | JMKX003002 FE experimental group |
| Placebo in Cohorts 1 to 5Also: Matching placebo will be administered orallyoral once | Drug | Placebo in Cohorts 1 to 5 |
| Placebo in 2 CohortsAlso: Matching placebo will be administered orallyoral once | Drug | Placebo in 2 Cohorts |
Primary outcome
Number of the Adverse Events that are related to the single dose treatment
Time frame: from baseline to Day 11
single dose safety
Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18
Time frame: from baseline to Day 18
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 18 Jun 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.
Jing Zhang principal investigator
Huashan 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 JMKX003002 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 3 inclusion and 3 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 18 Jun 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. 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?
Contact Jing Xu (021-52887926, xujing2@jimincare.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 11). 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 18 Jun 2023.