Healthy VolunteersPhase 1NCT03314402
The Tolerance, Pharmacokinetics of Jaktinib in Healthy Volunteers
A Phase 1 study testing Jaktinib Dihydrochloride Monohydrate in people with Healthy Volunteers, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of jaktinib. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Jaktinib Dihydrochloride Monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2017to 27 Sep 2018
- 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
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions;
- Be able to complete the research according to the clinical trial protocol;
- Subjects (include male subjects) have no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures;
- Male and female subjects between 18 and 45 years (inclusive) of age;
- The weight of a male subject is no lower than 50kg,The female is no lower than 45kg,and having a Body Mass Index (BMI) between 18 to 28 (both inclusive), calculated as weight in kg / height in m2;
- Health status: no clinical histories with clinical significance about heart, liver, kidney, digestive tract, nervous system, respiratory system (such as asthma), mental disorders and metabolic abnormalities and so on;
- Physical examination, vital signs normal or no clinical significance.
Who cannot join
- Someone smoking more than 5 pieces per day within the 3 months before the trial ；
- Allergies, such as allergies to Investigational Drug,excipients,or idiosyncratic reaction to drug and food;
- Having a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 units = beer 285 mL, or 25 mL of spirits, or 100 mL of wine)；
- Blood donation or extensive blood loss (> 450 mL) within three months of the use of the study drug;
- Having difficulty of swallowing or any history of gastrointestinal diseases that affect drug absorption;
- Suffering from any increased risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc.;
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- Taked any drug that changes liver enzyme activity 28 days prior to the use of the study drug;
- Taked any prescription, OTC drugs, any vitamin products or herbs within 14 days prior to the use of the study drug;
- Two weeks before the trial took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, and other activities that affect drug absorption, distribution, metabolism, excretion and so on;
- Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers, such as itraconazole, ketoconazole or dronedarone;
- There have been significant changes in diet or exercise habits recently;
- Taked research drugs within three months prior to the use of the study drug or participating in any drug clinical trial;
- Subjects who were intolerant of high-fat meals (2 boiled eggs, 100g, 20g Bacon, 1 slices of buttered toast, 50g, 115g fries, and 240 ml whole milk) were applied only to subjects who participated in the postprandial test.
- ECG has clinical significance;
- Female subjects are in lactation or serum pregnancy test are positive during screening or during the test;
- Clinical laboratory tests are abnormal and have clinical significance, or other clinical findings showing clinically significant diseases (including but not limited to gastrointestinal, renal, liver, nerves, blood, endocrine, neoplasms, lungs, immunizations, mental or heart Cerebrovascular disease);
- hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening test positive;
- Acute disease occurs before screening or using test drug;
- Taking chocolate, any caffeine, or xanthine-rich food or drink at least 48 hours prior to the use of the study drug;
- Taking any alcoholic products within 24 hours prior to the use of the study drug;
- Alcohol or drug screening positive or drug abuse history over the past five years or 3 months before the trial used by drug users.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind,Dose-escalation Phase 1 Study to Assess the Safety, Tolerance, and Pharmacokinetics of Jaktinib,an Oral JAK2 Inhibitor, in Healthy Volunteers
A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of jaktinib.
Read the detailed description
The study is a randomized, double-blind phase 1 trial including 3 independent parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part and postprandial pharmacokinetics part. SAD and MAD are dose-escalated tolerant study designed 8 cohorts and 5 cohorts in SAD and MAD respectively. The aims of the study as below:
- Evaluating the safety and tolerance of Jaktinib in healthy volunteers.
- Evaluating the fasting pharmacokinetic parameters of Jaktinib in healthy volunteers.
- Evaluating the postprandial pharmacokinetic parameters of jaktinib in healthy volunteers.
- Analysis the metabolites of Jaktinib
- Conditions
- Healthy Volunteers
- Being tested
- Jaktinib Dihydrochloride Monohydrate, placebo
- Keywords
- JAK2 inhibitor, Tolerance, Pharmacokinetics, Dose-escalated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaktinib Dihydrochloride MonohydrateDrug
Also called Jaktinib
Active Substance
placeboDrug
Also called PLA
Placebo
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Jaktinib Dihydrochloride Monohydrate Receives: Drug: Jaktinib Dihydrochloride Monohydrate |
| group 2 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated jaktinib
Measured: up to 6 months
Secondary outcomes (2)
Maximum Plasma Concentration [Cmax]
The parameter to evaluating the plasma concentration of the oral jaktinib
Measured: up to 120 hours
Area Under the Curve [AUC]
The parameter to evaluating the exposure of the oral jaktinib
Measured: up to 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start28 Sep 2017
- Primary completion30 Aug 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Model description
- SAD: 8 cohorts, 8 subjects take jaktinib and 2 subjects take placebo; MAD: 5 cohorts, 8 subjects take jaktinib and 2 subjects take placebo; Postprandial Phamocokinetics:12 subjects, crossover designing
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, MD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314402
- Sponsor's protocol ID
- ZGJAK001
- Status last verified
- Feb 2019
- First submitted
- 10 Oct 2017
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind,Dose-escalation Phase 1 Study to Assess the Safety, Tolerance, and Pharmacokinetics of Jaktinib,an Oral JAK2 Inhibitor, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03314402
- Acronym / sponsor ID
- ZGJAK001
- Conditions
- Healthy Volunteers
- Keywords
- JAK2 inhibitor, Tolerance, Pharmacokinetics, Dose-escalated
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 19 Oct 2017 (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.
A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of jaktinib.
Detailed description
The study is a randomized, double-blind phase 1 trial including 3 independent parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part and postprandial pharmacokinetics part. SAD and MAD are dose-escalated tolerant study designed 8 cohorts and 5 cohorts in SAD and MAD respectively. The aims of the study as below:
- Evaluating the safety and tolerance of Jaktinib in healthy volunteers.
- Evaluating the fasting pharmacokinetic parameters of Jaktinib in healthy volunteers.
- Evaluating the postprandial pharmacokinetic parameters of jaktinib in healthy volunteers.
- Analysis the metabolites of Jaktinib
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- SAD: 8 cohorts, 8 subjects take jaktinib and 2 subjects take placebo; MAD: 5 cohorts, 8 subjects take jaktinib and 2 subjects take placebo; Postprandial Phamocokinetics:12 subjects, crossover designing
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Jaktinib Dihydrochloride MonohydrateJaktinib Dihydrochloride Monohydrate |
| group 2 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions;
- Be able to complete the research according to the clinical trial protocol;
- Subjects (include male subjects) have no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures;
- Male and female subjects between 18 and 45 years (inclusive) of age;
- The weight of a male subject is no lower than 50kg,The female is no lower than 45kg,and having a Body Mass Index (BMI) between 18 to 28 (both inclusive), calculated as weight in kg / height in m2;
Key exclusion criteria (21 listed)
- Someone smoking more than 5 pieces per day within the 3 months before the trial ；
- Allergies, such as allergies to Investigational Drug,excipients,or idiosyncratic reaction to drug and food;
- Having a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 units = beer 285 mL, or 25 mL of spirits, or 100 mL of wine)；
- Blood donation or extensive blood loss (> 450 mL) within three months of the use of the study drug;
- Having difficulty of swallowing or any history of gastrointestinal diseases that affect drug absorption;
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 Dihydrochloride MonohydrateAlso: JaktinibActive Substance | Drug | group 1 |
| placeboAlso: PLAPlacebo | Drug | group 2 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: up to 6 months
Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated jaktinib
2 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: up to 120 hours
Area Under the Curve [AUC]
Time frame: up to 120 hours
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 1 Mar 2019.
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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.
Yanhua Ding, MD principal investigator
The First Hospital of Jilin 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 Dihydrochloride Monohydrate in people with Healthy Volunteers, 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 7 inclusion and 21 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 1 Mar 2019. 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?
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 Tolerated Dose (MTD) (time frame: up to 6 months). 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 1 Mar 2019.