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NCT Number: NCT07565597

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Third Hospital of Changsha

Changsha, Hunan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Gecacitinib Hydrochloride Tablets

Drug

Administered orally

Other names: Gecacitinib

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

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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