HealthyPhase 1NCT07565597
A Pharmacokinetic Study of Gecacitinib Hydrochloride Tablets in Healthy Adult Participants.
A Phase 1 study testing Gecacitinib Hydrochloride Tablets in people with Healthy, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This study will compare the pharmacokinetics (PK) effect of two different formulations of Gecacitinib Hydrochloride Tablets in healthy Adult participants Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gecacitinib Hydrochloride Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 study 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 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.
About this study
Official title: A Single-dose, Randomized, Open-label, Four-period, Replicate Crossover, Comparative Pharmacokinetic Study of Two Formulations of Gecacitinib Hydrochloride Tablets in Healthy Adult Participants Under Fasting Conditions.
This study will compare the pharmacokinetics (PK) effect of two different formulations of Gecacitinib Hydrochloride Tablets in healthy Adult participants
- Conditions
- Healthy
- Being tested
- Gecacitinib Hydrochloride Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gecacitinib Hydrochloride TabletsDrug
Also called Gecacitinib
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Participants will take a single Gecacitinib 75mg Tablet under fasting condition Receives: Drug: Gecacitinib Hydrochloride Tablets |
| Reference Group | Experimental | Participants will take a single Gecacitinib 75mg Tablet under fasting condition Receives: Drug: Gecacitinib Hydrochloride Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) Of Gecacitinib and its main metabolite ZG0244
Measured: up to 48 hours
Gecacitinib and its main metabolite ZG0244 AUC(0-t)
Measured: up to 48 hours
Gecacitinib and its main metabolite ZG0244 AUC(0-inf)
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start12 May 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565597
- Sponsor's protocol ID
- JY-I-JKXTN-2025-077
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2026
- Last updated
- 8 Jun 2026
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Randomized, Open-label, Four-period, Replicate Crossover, Comparative Pharmacokinetic Study of Two Formulations of Gecacitinib Hydrochloride Tablets in Healthy Adult Participants Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT07565597
- Acronym / sponsor ID
- JY-I-JKXTN-2025-077
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 12 May 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 May 2026 (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 study will compare the pharmacokinetics (PK) effect of two different formulations of Gecacitinib Hydrochloride Tablets in healthy Adult participants
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: Gecacitinib Hydrochloride TabletsParticipants will take a single Gecacitinib 75mg Tablet under fasting condition |
| Reference Group | Experimental | Drug: Gecacitinib Hydrochloride TabletsParticipants will take a single Gecacitinib 75mg Tablet under fasting condition |
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 study 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 (2 listed)
- Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug.
- Participants 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 |
|---|---|---|
| Gecacitinib Hydrochloride TabletsAlso: GecacitinibAdministered orally | Drug | Reference Group, Test Group |
Primary outcome
Maximum Plasma Concentration (Cmax) Of Gecacitinib and its main metabolite ZG0244
Time frame: up to 48 hours
Gecacitinib and its main metabolite ZG0244 AUC(0-t)
Time frame: up to 48 hours
Gecacitinib and its main metabolite ZG0244 AUC(0-inf)
Time frame: up to 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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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.
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 Gecacitinib Hydrochloride Tablets in people with Healthy, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Gecacitinib 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?
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 8 Jun 2026.