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Active, not recruitingNCT07565597Updated Jun 8, 2026

A Pharmacokinetic Study of Gecacitinib Hydrochloride Tablets in Healthy Adult Participants.

A Phase 1 interventional study of Gecacitinib Hydrochloride Tablets in Healthy, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This study will compare the pharmacokinetics (PK) effect of two different formulations of Gecacitinib Hydrochloride Tablets in healthy Adult participants

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd is the lead sponsor of 82 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Test Group

    Participants will take a single Gecacitinib 75mg Tablet under fasting condition

    Drug: Gecacitinib Hydrochloride Tablets

  • Experimental
    Reference Group

    Participants will take a single Gecacitinib 75mg Tablet under fasting condition

    Drug: Gecacitinib Hydrochloride Tablets

Interventions

  • DrugGecacitinib Hydrochloride Tablets

    Administered orally

    Also known as: Gecacitinib

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) Of Gecacitinib and its main metabolite ZG0244

    Time frame: up to 48 hours

  2. Gecacitinib and its main metabolite ZG0244 AUC(0-t)

    Time frame: up to 48 hours

  3. Gecacitinib and its main metabolite ZG0244 AUC(0-inf)

    Time frame: up to 48 hours

07

Study locations

1 site
  • The Third Hospital of Changsha
    Changsha, Hunan, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07565597
Lead sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Responsible party
Sponsor
First posted
May 4, 2026
Start date
May 12, 2026
Primary completion
Feb 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jun 8, 2026

Study contacts

Jason Wu
study chair · Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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