Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions

A Single-dose, Randomized, Open-label, Repeated Cross-over Pharmacokinetic Comparison Study of Two Formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers Under Fasted Conditions

To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers

Study Overview

• Status: Completed
• Conditions: Myelofibrosis
• Intervention / Treatment: Drug: Jaktinib Hydrochloride Tablets

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Third Hospital of Changsha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 trial 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 with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and still clinically relevant according to the investigator;
• Participants with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic system and other diseases that require medical intervention or are not suitable for clinical trial (such as psychiatric history);
• With positive alcohol breath test;
• Volunteers 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; Subjects in the first sequence of the first cycle were administered with a test formulation (T) of 50 mg of Jaktinib on an empty stomach, while subjects in the second sequence were administered with a reference formulation (R) of 50 mg of Jaktinib on an empty stomach. The reference formulation (R) or test formulation (T) was administered alternately in the next periods.	Drug: Jaktinib Hydrochloride Tablets; Orally, one tablet at a time; Other Names: Jaktinib
Active Comparator: Reference Group; Subjects in the first sequence of the first cycle were administered with a test formulation (T) of 50 mg of Jaktinib on an empty stomach, while subjects in the second sequence were administered with a reference formulation (R) of 50 mg of Jaktinib on an empty stomach. The reference formulation (R) or test formulation (T) was administered alternately in the next periods.	Drug: Jaktinib Hydrochloride Tablets; Orally, one tablet at a time; Other Names: Jaktinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244	Maximum Plasma Concentration (Cmax)	up to 48 hours
Jaktinib and its main metabolite ZG0244 AUC(0-t)	Area under the concentration time curve from time 0 to time of the last quantifiable	up to 48 hours
Jaktinib and its main metabolite ZG0244 AUC(0-inf)	Area under the concentration time curve from time 0 to infinity	up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jaktinib and its main metabolite ZG0244 Tmax	Maximum Plasma Concentration (Tmax)	up to 48 hours
Jaktinib and its main metabolite ZG0244 t1/2	Half Life (t1/2)	up to 48 hours
Adverse events		Day 1 to Day 12

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Study Chair: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Primary Myelofibrosis
• Other Study ID Numbers: ZGJAK037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No