Healthy AdultPhase 1NCT06344533
Study of JMKX003142 Injection in Chinese Healthy Subjects
A Phase 1 study testing JMKX003142 Injection in people with Healthy Adult, run by Jemincare at 1 site in China.
Trial summary
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- JMKX003142 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2024to 30 May 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 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
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Haiyan Li
Haiyan Li, MD
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects
- Conditions
- Healthy Adult
- Being tested
- JMKX003142 Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX003142 InjectionDrug
JMKX003142 Injection will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.
PlaceboDrug
Matching placebo will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| JMKX003142 Injection | Experimental | Single and multiple doses of JMKX003142 Injection administered intravenously. Receives: Drug: JMKX003142 Injection |
| Placebo | Placebo comparator | Placebo administered intravenously. Receives: Drug: Placebo |
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 single dose safety
Measured: From Baseline to Day7
Number of the Adverse Events that are related to the multiple dose treatment
multiple dose safety multiple dose safety
Measured: From Baseline to Day12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start10 Apr 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344533
- Sponsor's protocol ID
- JMKX003142iv-101
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cui C, Zhu J, Liu Z, Liu J, Huang X, Liu Y, Hu J, Zhang L, Zhang X, Sha Y, Liu D, Li H. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Administration JMKX003142 in Chinese Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single, and Multiple Ascending Dose Phase I Clinical Trial. Drug Des Devel Ther. 2026 Mar 5;20:583445. doi: 10.2147/DDDT.S583445. eCollection 2026.
PubMed 41810128
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. 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 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06344533
- Acronym / sponsor ID
- JMKX003142iv-101
- Conditions
- Healthy Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Study start
- 10 Apr 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 3 Apr 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.
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JMKX003142 Injection | Experimental | Drug: JMKX003142 InjectionSingle and multiple doses of JMKX003142 Injection administered intravenously. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered intravenously. |
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 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 InjectionJMKX003142 Injection will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days. | Drug | JMKX003142 Injection |
| PlaceboMatching placebo will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days. | Drug | Placebo |
Primary outcome
Number of the Adverse Events that are related to the single dose treatment
Time frame: From Baseline to Day7
single dose safety single dose safety
Number of the Adverse Events that are related to the multiple dose treatment
Time frame: From Baseline to Day12
multiple dose safety 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 3 Apr 2024.
- Derived from this study: PubMed 41810128Cui C, Zhu J, Liu Z, Liu J, Huang X, Liu Y, Hu J, Zhang L, Zhang X, Sha Y, Liu D, Li H. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Administration JMKX003142 in Chinese Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single, and Multiple Ascending Dose Phase I Clinical Trial. Drug Des Devel Ther. 2026 Mar 5;20:583445. doi: 10.2147/DDDT.S583445. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
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 Injection in people with Healthy Adult, 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 3 Apr 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?
Contact Yiming Dong, MD (021-58306003, dongyiming@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 Day7). 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?
On the ClinicalTrials.gov record for NCT06344533, which also lists 1 linked publication.
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 3 Apr 2024.