Healthy ParticipantsPhase 1NCT06193148
A Study to Evaluate the Effect of Jaktinib on QT/QTc Interval in Healthy Participants
A Phase 1 study testing Jaktinib in people with Healthy Participants, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
To evaluate the effect of Jaktinib Hydrochloride Tablets on QT/QTc interval in healthy subjects after a single oral administration. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Jaktinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2024to 18 Jun 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
- Voluntarily sign informed consent, able to comply with the requirements of the study.
- Age 18-45 years old, both male and female;
- Weight: male ≥ 50 kg, female ≥ 45 kg, 19 kg/m^2 ≤ BMI ≤26 kg/m^2.
- 12-lead electrocardiogram (ECG) examination, 300 ms≤QTcF<450 ms, 120 ms≤PR interval ≤200 ms, and QRS duration <120 ms;
- The subjects (including male subjects) are willing to voluntarily take effective contraceptive measures within the next 3 months.
Who cannot join
- Have a history of risk factors for torsade de pointes, or have a family history of short QT syndrome, long QT syndrome, unexplained sudden death in young adulthood (≤40 years old), drowning or sudden infant death syndrome in first-degree relatives;
- Previous history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia;
- Subjects who had donated blood or lost ≥400 mL of blood within 3 months before screening;
- HBsAg, HCV antibody, HIV antibody, or TP antibody antibody positive.
- Women with positive blood pregnancy test (applicable to women) or lactating women;
- Subjects who have other factors that the investigator considers unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effect of Oral Administration of Jaktinib Hydrochloride Tablets on QT/Corrected QT (QTc) Interval in Healthy Participants
To evaluate the effect of Jaktinib Hydrochloride Tablets on QT/QTc interval in healthy subjects after a single oral administration.
- Conditions
- Healthy Participants
- Being tested
- Jaktinib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JaktinibDrug
Participants will receive Jaktinib orally for single dose
PlaceboDrug
Participants will receive Placebo orally for single dose
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib 100mg | Experimental | 6 Participants will receive Jaktinib 100 mg, orally; 2 Participants will receive placebo, orally. Receives: Drug: Jaktinib; Drug: Placebo |
| Jaktinib 400mg | Experimental | 6 Participants will receive Jaktinib 400 mg, orally; 2 Participants will receive placebo, orally. Receives: Drug: Jaktinib; Drug: Placebo |
| Jaktinib 600mg | Experimental | 6 Participants will receive Jaktinib 600 mg, orally; 2 Participants will receive placebo, orally. Receives: Drug: Jaktinib; Drug: Placebo |
| Jaktinib 800mg | Experimental | 6 Participants will receive Jaktinib 800 mg, orally; 2 Participants will receive placebo, orally. Receives: Drug: Jaktinib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT Interval Corrected Using Fridericia's Formula
Model-guided placebo-corrected change in QTcF from baseline (ΔΔQTcF)
Measured: From before dosing until 48 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start19 Mar 2024
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LiYan Miao, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193148
- Sponsor's protocol ID
- ZGJAK039
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Oral Administration of Jaktinib Hydrochloride Tablets on QT/Corrected QT (QTc) Interval in Healthy Participants
- ClinicalTrials.gov ID
- NCT06193148
- Acronym / sponsor ID
- ZGJAK039
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 5 Jan 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 effect of Jaktinib Hydrochloride Tablets on QT/QTc interval in healthy subjects after a single oral administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Jaktinib 100mg | Experimental | Drug: Jaktinib, Drug: Placebo6 Participants will receive Jaktinib 100 mg, orally; 2 Participants will receive placebo, orally. |
| Jaktinib 400mg | Experimental | Drug: Jaktinib, Drug: Placebo6 Participants will receive Jaktinib 400 mg, orally; 2 Participants will receive placebo, orally. |
| Jaktinib 600mg | Experimental | Drug: Jaktinib, Drug: Placebo6 Participants will receive Jaktinib 600 mg, orally; 2 Participants will receive placebo, orally. |
| Jaktinib 800mg | Experimental | Drug: Jaktinib, Drug: Placebo6 Participants will receive Jaktinib 800 mg, orally; 2 Participants will receive placebo, orally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntarily sign informed consent, able to comply with the requirements of the study.
- Age 18-45 years old, both male and female;
- Weight: male ≥ 50 kg, female ≥ 45 kg, 19 kg/m^2 ≤ BMI ≤26 kg/m^2.
- 12-lead electrocardiogram (ECG) examination, 300 ms≤QTcF<450 ms, 120 ms≤PR interval ≤200 ms, and QRS duration <120 ms;
- The subjects (including male subjects) are willing to voluntarily take effective contraceptive measures within the next 3 months.
Key exclusion criteria (6 listed)
- Have a history of risk factors for torsade de pointes, or have a family history of short QT syndrome, long QT syndrome, unexplained sudden death in young adulthood (≤40 years old), drowning or sudden infant death syndrome in first-degree relatives;
- Previous history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia;
- Subjects who had donated blood or lost ≥400 mL of blood within 3 months before screening;
- HBsAg, HCV antibody, HIV antibody, or TP antibody antibody positive.
- Women with positive blood pregnancy test (applicable to women) 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 |
|---|---|---|
| JaktinibParticipants will receive Jaktinib orally for single dose | Drug | Jaktinib 100mg, Jaktinib 400mg, Jaktinib 600mg, Jaktinib 800mg |
| PlaceboParticipants will receive Placebo orally for single dose | Drug | Jaktinib 100mg, Jaktinib 400mg, Jaktinib 600mg, Jaktinib 800mg |
Primary outcome
QT Interval Corrected Using Fridericia's Formula
Time frame: From before dosing until 48 hours after dosing
Model-guided placebo-corrected change in QTcF from baseline (ΔΔQTcF)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
LiYan Miao principal investigator
The First Affiliated Hospital of Soochow 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 Jaktinib in people with Healthy Participants, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 12 Dec 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QT Interval Corrected Using Fridericia's Formula (time frame: From before dosing until 48 hours after dosing). 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 12 Dec 2024.