NCT07565597

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
9mo left

Started Jun 2026

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

    up to 48 hours

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

    up to 48 hours

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

    up to 48 hours

Study Arms (2)

Test Group

EXPERIMENTAL

Formulation 1

Drug: Gecacitinib Hydrochloride Tablets

Reference Group

EXPERIMENTAL

Formulation 2

Drug: Gecacitinib Hydrochloride Tablets

Interventions

Gecacitinib Hydrochloride TabletsDRUG

Administered orally

Also known as: Gecacitinib
Reference GroupTest Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ≤ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Hospital of Changsha

Changsha, Hunan, China

Location

Study Officials

  • Jason Wu

    Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    STUDY CHAIR

Central Study Contacts

Bo Liu

CONTACT

+86-0512-57309965liub@zelgen.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

CN(1)