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

NCT06132243 | Completed Phase 1

• 1 other identifier: ZGJAK037
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Jaktinib and its main metabolite ZG0244 Tmax

  up to 48 hours

• Jaktinib and its main metabolite ZG0244 t1/2

  up to 48 hours

• Adverse events

  Day 1 to Day 12

Study Arms (2)

Test Group

EXPERIMENTAL

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

Reference Group

ACTIVE COMPARATOR

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

Interventions

Jaktinib Hydrochloride Tablets DRUG

Orally, one tablet at a time

Also known as: Jaktinib

Reference Group; Test Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 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.

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 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The Third Hospital of Changsha

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

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: November 9, 2023
• First Posted: November 15, 2023
• Study Start: November 29, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)