HealthyPhase 1NCT06549309
Trial of JMKX003801 in Healthy Participants
A Phase 1 study testing JMKX003801 in people with Healthy, run by Jemincare at 1 site in China.
Trial summary
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult Participants Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JMKX003801
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2024to 12 Jun 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
- 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;
- Healthy adult males and/or females, 18 to 45 years of age;
- Body mass index (BMI) ≥ 19 and ≤ 28.0 (kg/m2) ,weight ≥45kg (female) or ≥50kg (male) .
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, or any other diseases judged by investigators that will be interference to the results of this study;
- Use of any over-the-counter (OTC) medication, prescription medicine, Chinese herbal medicine , within 2 weeks prior to the time of informed consent signed;
- Pregnant or lactating women;
- Other conditions unsuitable for the trial judged by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality
Jing Zhang, +8613816357098, zhangj_fudan@163.com
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of JMKX003801 in Healthy Participants
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult Participants
- Conditions
- Healthy
- Being tested
- JMKX003801, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX003801Drug
For Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation.
For Ascending Multiple Dose of JMKX003801，Three（3）cohort of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation.
PlaceboDrug
For Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation.
For Ascending Multiple Dose of JMKX003801，Three（3）cohorts of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | JMKX003801 Receives: Drug: JMKX003801 |
| Placebo Comparator | Placebo comparator | Normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence and features of AEs
Measured: From baseline to Day 3
Secondary outcomes (1)
Serum concentrations of JMKX003801
Serum concentrations of JMKX003801
Measured: From baseline to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start17 Aug 2024
- Primary completion31 May 2025 (estimated)
- Study completion12 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 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
- NCT06549309
- Sponsor's protocol ID
- JMKX003801-101
- Status last verified
- Sep 2024
- First submitted
- 8 Aug 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of JMKX003801 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06549309
- Acronym / sponsor ID
- JMKX003801-101
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 12 Jun 2025 (estimated)
- First posted
- 12 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.
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Drug: JMKX003801JMKX003801 |
| Placebo Comparator | Placebo comparator | Drug: PlaceboNormal saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
- Healthy adult males and/or females, 18 to 45 years of age;
- Body mass index (BMI) ≥ 19 and ≤ 28.0 (kg/m2) ,weight ≥45kg (female) or ≥50kg (male) .
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, or any other diseases judged by investigators that will be interference to the results of this study;
- Use of any over-the-counter (OTC) medication, prescription medicine, Chinese herbal medicine , within 2 weeks prior to the time of informed consent signed;
- Pregnant or lactating women;
- Other conditions unsuitable for the trial judged by the investigators.
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 |
|---|---|---|
| JMKX003801For Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation. For Ascending Multiple Dose of JMKX003801，Three（3）cohort of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation. | Drug | Experimental |
| PlaceboFor Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation. For Ascending Multiple Dose of JMKX003801，Three（3）cohorts of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation. | Drug | Placebo Comparator |
Primary outcome
Adverse events (AEs)
Time frame: From baseline to Day 3
Incidence and features of AEs
1 secondary outcome
Serum concentrations of JMKX003801
Time frame: From baseline to Day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- 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.
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 JMKX003801 in people with Healthy, 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 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 26 Sep 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 Hongzhang Ji (+8618261053520, jihongzhang@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: From baseline to Day 3). 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 26 Sep 2024.