Solid Tumor, AdultPhase 1NCT06473948
To Assess the Effects of Single Dose of JMKX001899 on QTc Interval in Healthy Subjects
A Phase 1 study testing JMKX001899 in people with Solid Tumor, Adult, run by Jemincare.
Trial summary
Study to assess the effect of JMKX001899 on QTc interval in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- JMKX001899
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2024to 27 Feb 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
- Healthy, adult, male or female 18-45 years of age, inclusive.
- Body mass index (BMI) between 19 and 28 kg/m2 (inclusive) and weight at least 50 kg.
- Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
Who cannot join
- Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma.
- Female subjects with a positive pregnancy test or lactating.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or Treponema pallidum（TP-Ab）
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effect of JMKX001899 on the QTc Interval in Healthy Subjects
Study to assess the effect of JMKX001899 on QTc interval in healthy volunteers
Read the detailed description
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of JMKX001899 Administered as a Tablet Formulation Under Fed Conditions in Healthy Subjects
- Conditions
- Solid Tumor, Adult
- Being tested
- JMKX001899, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX001899Drug
Participants will receive JMKX001899 500mg tablet, orally once on Day 1
JMKX001899Drug
Participants will receive JMKX001899 750mg tablet, orally once on Day 1
JMKX001899Drug
Participants will receive JMKX001899 1000mg tablet, orally once on Day 1
PlaceboDrug
Participants will receive JMKX001899 matching placebo, tablet, orally once on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive JMKX001899 500 once on Day 1 Receives: Drug: JMKX001899; Drug: Placebo |
| Cohort 2 | Experimental | Participants will receive JMKX001899 750 once on Day 1 Receives: Drug: JMKX001899; Drug: Placebo |
| Cohort 3 | Experimental | Participants will receive JMKX001899 1000 once on Day 1 Receives: Drug: JMKX001899; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of a single dose of JMKX001899 on the change in time-matched QTc intervals compared with placebo
QTc interval was measured by electrocardiograms to evaluate the potential effect of JMKX001899 plasma concentrations on the QTc interval using linear mixed-effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start10 Jul 2024 (estimated)
- Primary completion24 Sep 2024 (estimated)
- Study completion27 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473948
- Sponsor's protocol ID
- JY-JM1899-106
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effect of JMKX001899 on the QTc Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06473948
- Acronym / sponsor ID
- JY-JM1899-106
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2024 (estimated)
- Primary completion
- 24 Sep 2024 (estimated)
- Study completion
- 27 Feb 2025 (estimated)
- First posted
- 25 Jun 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.
Study to assess the effect of JMKX001899 on QTc interval in healthy volunteers
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of JMKX001899 Administered as a Tablet Formulation Under Fed Conditions in Healthy Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: JMKX001899, Drug: PlaceboParticipants will receive JMKX001899 500 once on Day 1 |
| Cohort 2 | Experimental | Drug: JMKX001899, Drug: PlaceboParticipants will receive JMKX001899 750 once on Day 1 |
| Cohort 3 | Experimental | Drug: JMKX001899, Drug: PlaceboParticipants will receive JMKX001899 1000 once on Day 1 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, adult, male or female 18-45 years of age, inclusive.
- Body mass index (BMI) between 19 and 28 kg/m2 (inclusive) and weight at least 50 kg.
- Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
Key exclusion criteria (3 listed)
- Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma.
- Female subjects with a positive pregnancy test or lactating.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or Treponema pallidum（TP-Ab）
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 |
|---|---|---|
| JMKX001899Participants will receive JMKX001899 500mg tablet, orally once on Day 1 | Drug | Cohort 1 |
| JMKX001899Participants will receive JMKX001899 750mg tablet, orally once on Day 1 | Drug | Cohort 2 |
| JMKX001899Participants will receive JMKX001899 1000mg tablet, orally once on Day 1 | Drug | Cohort 3 |
| PlaceboParticipants will receive JMKX001899 matching placebo, tablet, orally once on Day 1 | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
To evaluate the effect of a single dose of JMKX001899 on the change in time-matched QTc intervals compared with placebo
Time frame: 48 hours
QTc interval was measured by electrocardiograms to evaluate the potential effect of JMKX001899 plasma concentrations on the QTc interval using linear mixed-effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMKX001899 in people with Solid Tumor, Adult, run by Jemincare.
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 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 WEIXIA LI (15000279084 ext. +86, liweixia@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of a single dose of JMKX001899 on the change in time-matched QTc intervals compared with placebo (time frame: 48 hours). 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 25 Jun 2024.