MyelofibrosisPhase 1NCT06132243

Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions

A Phase 1 study testing Jaktinib Hydrochloride Tablets in people with Myelofibrosis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Myelofibrosis
What is being tested?: Jaktinib Hydrochloride Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteChina
Study dates: 29 Nov 2023to 20 Dec 2023
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

18≤ age ≤ 45, male or female;
Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m^2 (inclusive);
Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood;
The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.

Who cannot join

Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug;
Participants with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and still clinically relevant according to the investigator;
Participants with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic system and other diseases that require medical intervention or are not suitable for clinical trial (such as psychiatric history);
With positive alcohol breath test;
Volunteers may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

The Third Hospital of Changsha
Changsha, Hunan, 410011

Other trials in China

About this study

Official title: A Single-dose, Randomized, Open-label, Repeated Cross-over Pharmacokinetic Comparison Study of Two Formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers Under Fasted Conditions

To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers

Conditions: Myelofibrosis
Being tested: Jaktinib Hydrochloride Tablets
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 TabletsDrug
Also called Jaktinib
Orally, one tablet at a time

Study groups in NCT06132243
Study group	Role	What they receive
Test Group	Experimental	Subjects in the first sequence of the first cycle were administered with a test formulation (T) of 50 mg of Jaktinib on an empty stomach, while subjects in the second sequence were administered with a reference formulation (R) of 50 mg of Jaktinib on an empty stomach. The reference formulation (R) or test formulation (T) was administered alternately in the next periods. Receives: Drug: Jaktinib Hydrochloride Tablets
Reference Group	Active comparator	Subjects in the first sequence of the first cycle were administered with a test formulation (T) of 50 mg of Jaktinib on an empty stomach, while subjects in the second sequence were administered with a reference formulation (R) of 50 mg of Jaktinib on an empty stomach. The reference formulation (R) or test formulation (T) was administered alternately in the next periods. Receives: Drug: Jaktinib Hydrochloride Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244
Maximum Plasma Concentration (Cmax)
Measured: up to 48 hours
Jaktinib and its main metabolite ZG0244 AUC(0-t)
Area under the concentration time curve from time 0 to time of the last quantifiable
Measured: up to 48 hours
Jaktinib and its main metabolite ZG0244 AUC(0-inf)
Area under the concentration time curve from time 0 to infinity
Measured: up to 48 hours

Secondary outcomes (3)

Jaktinib and its main metabolite ZG0244 Tmax
Maximum Plasma Concentration (Tmax)
Measured: up to 48 hours
Jaktinib and its main metabolite ZG0244 t1/2
Half Life (t1/2)
Measured: up to 48 hours
Adverse events
Measured: Day 1 to Day 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 202320 Dec 2023

First posted15 Nov 2023
Study start29 Nov 2023
Primary completion20 Dec 2023
Study completion20 Dec 2023

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06132243
Sponsor's protocol ID: ZGJAK037
Status last verified: Jan 2024
First submitted: 9 Nov 2023
Last updated: 11 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 3
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Myelofibrosis, Anemia
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
Active, not recruitingPhase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

All Myelofibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-dose, Randomized, Open-label, Repeated Cross-over Pharmacokinetic Comparison Study of Two Formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers Under Fasted Conditions
ClinicalTrials.gov ID: NCT06132243
Acronym / sponsor ID: ZGJAK037
Conditions: Myelofibrosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
Study start: 29 Nov 2023 (actual)
Primary completion: 20 Dec 2023 (actual)
Study completion: 20 Dec 2023 (actual)
First posted: 15 Nov 2023 (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 pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test Group	Experimental	Drug: Jaktinib Hydrochloride TabletsSubjects in the first sequence of the first cycle were administered with a test formulation (T) of 50 mg of Jaktinib on an empty stomach, while subjects in the second sequence were administered with a reference formulation (R) of 50 mg of Jaktinib on an empty stomach. The reference formulation (R) or test formulation (T) was administered alternately in the next periods.
Reference Group	Active comparator	Drug: Jaktinib Hydrochloride TabletsSubjects in the first sequence of the first cycle were administered with a test formulation (T) of 50 mg of Jaktinib on an empty stomach, while subjects in the second sequence were administered with a reference formulation (R) of 50 mg of Jaktinib on an empty stomach. The reference formulation (R) or test formulation (T) was administered alternately in the next periods.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

18≤ age ≤ 45, male or female;
Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m^2 (inclusive);
Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood;
The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.

Key exclusion criteria (5 listed)

Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug;
Participants with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and still clinically relevant according to the investigator;
Participants with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic system and other diseases that require medical intervention or are not suitable for clinical trial (such as psychiatric history);
With positive alcohol breath test;
Volunteers may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.

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 TabletsAlso: JaktinibOrally, one tablet at a time	Drug	Reference Group, Test Group

Primary outcome

Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244
Time frame: up to 48 hours
Maximum Plasma Concentration (Cmax)
Jaktinib and its main metabolite ZG0244 AUC(0-t)
Time frame: up to 48 hours
Area under the concentration time curve from time 0 to time of the last quantifiable
Jaktinib and its main metabolite ZG0244 AUC(0-inf)
Time frame: up to 48 hours
Area under the concentration time curve from time 0 to infinity

3 secondary outcomes

Jaktinib and its main metabolite ZG0244 Tmax
Time frame: up to 48 hours
Jaktinib and its main metabolite ZG0244 t1/2
Time frame: up to 48 hours
Adverse events
Time frame: Day 1 to Day 12

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 11 Jan 2024.
Individual participant dataSharing planned: No

Related trials for Myelofibrosis

RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 3
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Myelofibrosis, Anemia
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
Active, not recruitingPhase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

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.

Jason Wu study chair

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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 Tablets in people with Myelofibrosis, 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 4 inclusion and 5 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 11 Jan 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?

Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244 (time frame: up to 48 hours). The study lists 3 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 NCT06132243.

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 11 Jan 2024.