MyelofibrosisPhase 1NCT05279001
A Safety and Tolerability Study of Jaktinib
A Phase 1 study testing Jaktinib Hydrochloride Tablet in people with Myelofibrosis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in United States.
Trial summary
This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- Jaktinib Hydrochloride Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 30 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia).
- Relapsed/refractory to a marketed (FDA approved) JAK inhibitor.
- At least 18 years of age.
- ECOG PS 0, 1, or 2.
- Expected life expectancy is greater than 24 weeks.
Who cannot join
- Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
- Major surgery or radiation therapy within 28 days prior to initiation of study drug.
- With suspected allergies to jaktinib or its excipient.
- Another clinical trial of a new drug or medical instrument within 3 months before screening.
- Females who are pregnant, currently breastfeeding, planning to become pregnant.
- Unable to adopt effective contraceptive methods during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Site 01
Canton, Ohio, 44718
Jason Wu, wujs@zelgen.com
About this study
Official title: A Phase 1 Dose Escalation, Safety and Tolerability Study of Jaktinib in Patients With Primary Myelofibrosis (PMF) or Post-polycythemia Vera/Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) and Who Are Relapsed/ Refractory to a Marketed JAK Inhibitor
This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.
Read the detailed description
This study is a Phase 1, single-arm, open-label, dose escalation trial, to evaluate the safety and tolerability of Jaktinib in patients with PMF or Post-PV/ET MF and who are relapsed/refractory to a marketed JAK inhibitor
- Conditions
- Myelofibrosis
- Being tested
- Jaktinib Hydrochloride Tablet
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaktinib Hydrochloride TabletDrug
Orally administered, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib | Experimental | Not described Receives: Drug: Jaktinib Hydrochloride Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of jaktinib hydrochloride tablets
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: At least 24 weeks, up to approximately 1 year for follow-up
Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: 28 days
Secondary outcomes (8)
Efficacy of jaktinib hydrochloride tablets
reduction of spleen volume of ≥35%
Measured: at least 24 weeks, up to approximately 1 year
Efficacy of jaktinib hydrochloride tablets
reduction of total symptoms score (TSS) of ≥50%
Measured: at least 24 weeks, up to approximately 1 year
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Peak Plasma Concentration (Cmax)
Measured: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time to maximum concentration (Tmax)
Measured: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Half-life (T1/2)
Measured: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Clearance (CL/F)
Measured: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Area under Curve (AUCinf)
Measured: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Volume of distribution
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Jul 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279001
- Sponsor's protocol ID
- ZGJAKUS001
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation, Safety and Tolerability Study of Jaktinib in Patients With Primary Myelofibrosis (PMF) or Post-polycythemia Vera/Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) and Who Are Relapsed/ Refractory to a Marketed JAK Inhibitor
- ClinicalTrials.gov ID
- NCT05279001
- Acronym / sponsor ID
- ZGJAKUS001
- Conditions
- Myelofibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 15 Mar 2022 (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.
This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.
Detailed description
This study is a Phase 1, single-arm, open-label, dose escalation trial, to evaluate the safety and tolerability of Jaktinib in patients with PMF or Post-PV/ET MF and who are relapsed/refractory to a marketed JAK inhibitor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jaktinib | Experimental | Drug: Jaktinib Hydrochloride Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia).
- Relapsed/refractory to a marketed (FDA approved) JAK inhibitor.
- At least 18 years of age.
- ECOG PS 0, 1, or 2.
- Expected life expectancy is greater than 24 weeks.
Key exclusion criteria (6 listed)
- Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
- Major surgery or radiation therapy within 28 days prior to initiation of study drug.
- With suspected allergies to jaktinib or its excipient.
- Another clinical trial of a new drug or medical instrument within 3 months before screening.
- Females who are pregnant, currently breastfeeding, planning to become pregnant.
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 |
|---|---|---|
| Jaktinib Hydrochloride TabletOrally administered, twice a day | Drug | Jaktinib |
Primary outcome
Safety of jaktinib hydrochloride tablets
Time frame: At least 24 weeks, up to approximately 1 year for follow-up
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets
Time frame: 28 days
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
8 secondary outcomes
Efficacy of jaktinib hydrochloride tablets
Time frame: at least 24 weeks, up to approximately 1 year
Efficacy of jaktinib hydrochloride tablets
Time frame: at least 24 weeks, up to approximately 1 year
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time frame: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time frame: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time frame: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time frame: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time frame: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 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.
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 Hydrochloride Tablet in people with Myelofibrosis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 21 Mar 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Wu, M.D (+86-21-58942758, wujs@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of jaktinib hydrochloride tablets (time frame: At least 24 weeks, up to approximately 1 year for follow-up). 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 21 Mar 2024.