Healthy VolunteersPhase 1NCT04715529
Phase 1 Study to Evaluate Safety and Pharmacokinetics of FZJ-003 in Healthy Volunteers
A Phase 1 study testing FZJ-003 in people with Healthy Volunteers, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical 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 FZJ-003, an oral Janus kinase1 (JAK1) inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- FZJ-003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2021to 13 Jul 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent；
- Communicate well with the researcher and be able to complete the research in accordance with the research regulations；
- No plan for pregnancy in the next 6 months and voluntarily take effective contraceptive measures; No plan for sperm or egg donation；
- Healthy male and/or female subjects between the ages of 18 and 50 years ( inclusive)；
- Male body weight≥50.0kg or female body weight≥45.0kg; Body Mass Index (BMI) between 18 to 28 (both inclusive), calculated as weight in kg / height in m2.
Who cannot join
- Someone smoking more than 5 pieces per day within the 3 months before the trial；
- Suspected of being allergic to investigational drug or any ingredient in the investigational drug, or people with allergies (multi-drug or food allergies)；
- Having a history of 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 ≥400 mL within 3 months before screening, or planning blood donors during the study;
- Urine drug test positive or have a history of drug abuse or drug use in the past 5 years;
- Subjects who were intolerant of high-fat meals (2 boiled eggs, 1 slices of buttered bacon toast, a box of fries, and a glass of whole milk) were applied only to subjects who participated in the postprandial test;
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- Taked any drug within 14 days before screening, including prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products (except regular supplementary vitamins);
- Taked any drug that changes liver drug enzyme activity within 28 days before screening, such as CYP3A4 inhibitors or inducers;
- Major changes in diet or exercise habits within 2 weeks before screening or during the period from screening to administration;
- Took a special diet (including dragon fruit, mango, grapefruit, etc.) or strenuous exercise, and other activities that affect drug absorption, distribution, metabolism, excretion and so on within 2 weeks before screening;
- Received or planned to receive any vaccine within 30 days before and after the trial;
- Participated in clinical trials within 3 months before the first administration of the study, or planned to participate in other clinical trials during the study period;
- Having difficulty of swallowing or any history of gastrointestinal diseases that affect drug absorption;
- With low immune function or immunodeficiency, or long-term use of immunosuppressive drugs; or used immunosuppressive drugs within 30 days before screeing;
- Have or have had malignant tumors；
- Active tuberculosis; or have a history of tuberculosis or latent tuberculosis infection; tuberculosis infection T cell spot test positive;
- Any infection that has been determined to be clinically significant by the investigator within 3 months or any infection within 7 days before the study;
- Herpes or varicella within 3 months before the trial;
- Underwent major trauma or major surgery in 3 months before screening, or have plan for surgery in trial;
- Have a history of diverticulitis, peptic ulcer or perforation of digestive tract；
- Clinical laboratory tests are abnormal and have clinical significance, or other clinical findings showing clinically significant diseases (including but not limited to heart Cerebrovascular, gastrointestinal, lungs, endocrine, renal, nerves, blood, immunizations, or mental disease);
- Active viral hepatitis (B or C) as demonstrated by positive serology at Screening；or test positive for human immunodeficiency virus (HIV) at Screening; or syphilis treponema pallidum antibody and syphilis rapid plasma reagin test are positive;
- QTcB interval greater than (>) 470 (male) or 480 (female) milliseconds;
- Female subjects are in lactation or serum pregnancy test are positive during screening or during the test;
- Acute illness or combination therapy from the screening stage to administration;
- 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, or cannot limit alcohol drinks as required in trial;
- Other circumstances that is deemed not appropriate for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Bethune Hospital of Jilin University
Changchun, Jilin, 130000
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation and Food Effect Study to Assess the Safety, Tolerance, and Pharmacokinetics of FZJ-003 In Healthy Volunteers
A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of FZJ-003, an oral Janus kinase1 (JAK1) inhibitor.
- Conditions
- Healthy Volunteers
- Being tested
- FZJ-003, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FZJ-003Drug
Subjects will receive FZJ-003 oral capsules in a dose escalation format.
PlaceboDrug
Subjects will receive placebo oral capsules (matching FZJ-003) in a dose escalation format .
| Study group | Role | What they receive |
|---|---|---|
| FZJ-003 | Experimental | Not described Receives: Drug: FZJ-003 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability
Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; ECG testing). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.
Measured: up to 72 hours postdose
Secondary outcomes (3)
Maximum Plasma Concentration (Cmax)
Measured: up to 72 hours postdose
Area under the plasma concentration-time curve (AUC)
Measured: up to 72 hours postdose
Pharmacodynamics (PD) parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers
Measured: up to 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start27 Jan 2021
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
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.
- 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 and MAD: 6 cohorts, 8 subjects take FZJ-003 and 2 subjects take placebo; Food Effect on Phamocokinetics: 14 subjects, crossover designing
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715529
- Sponsor's protocol ID
- F0025-101
- Status last verified
- May 2023
- First submitted
- 19 Jan 2021
- Last updated
- 12 Mar 2025
- 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation and Food Effect Study to Assess the Safety, Tolerance, and Pharmacokinetics of FZJ-003 In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04715529
- Acronym / sponsor ID
- F0025-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 20 Jan 2021 (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 FZJ-003, an oral Janus kinase1 (JAK1) inhibitor.
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 and MAD: 6 cohorts, 8 subjects take FZJ-003 and 2 subjects take placebo; Food Effect on Phamocokinetics: 14 subjects, crossover designing
| Arm | Type | Receives |
|---|---|---|
| FZJ-003 | Experimental | Drug: FZJ-003 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent；
- Communicate well with the researcher and be able to complete the research in accordance with the research regulations；
- No plan for pregnancy in the next 6 months and voluntarily take effective contraceptive measures; No plan for sperm or egg donation；
- Healthy male and/or female subjects between the ages of 18 and 50 years ( inclusive)；
- Male body weight≥50.0kg or female body weight≥45.0kg; Body Mass Index (BMI) between 18 to 28 (both inclusive), calculated as weight in kg / height in m2.
Key exclusion criteria (28 listed)
- Someone smoking more than 5 pieces per day within the 3 months before the trial；
- Suspected of being allergic to investigational drug or any ingredient in the investigational drug, or people with allergies (multi-drug or food allergies)；
- Having a history of 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 ≥400 mL within 3 months before screening, or planning blood donors during the study;
- Urine drug test positive or have a history of drug abuse or drug use in the past 5 years;
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 |
|---|---|---|
| FZJ-003Subjects will receive FZJ-003 oral capsules in a dose escalation format. | Drug | FZJ-003 |
| PlaceboSubjects will receive placebo oral capsules (matching FZJ-003) in a dose escalation format . | Drug | Placebo |
Primary outcome
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to 72 hours postdose
Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; ECG testing). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.
3 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: up to 72 hours postdose
Area under the plasma concentration-time curve (AUC)
Time frame: up to 72 hours postdose
Pharmacodynamics (PD) parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers
Time frame: up to 24 hours postdose
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 Mar 2025.
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 FZJ-003 in people with Healthy Volunteers, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical 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 28 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 Mar 2025. 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?
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability (time frame: up to 72 hours postdose). 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 Mar 2025.