The Tolerance, Pharmacokinetics of Jaktinib in Healthy Volunteers

NCT03314402 | Completed Phase 1

• 1 other identifier: ZGJAK001
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of jaktinib.

Conditions

Healthy Volunteers

Keywords

JAK2 inhibitor; Tolerance; Pharmacokinetics; Dose-escalated

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  Evaluating Dose-Limiting Toxicities (DLTs) from the individuals taking orally dose-escalated jaktinib

  up to 6 months

Secondary Outcomes (2)

• Maximum Plasma Concentration [Cmax]

  up to 120 hours

• Area Under the Curve [AUC]

  up to 120 hours

Study Arms (2)

group 1

EXPERIMENTAL

Jaktinib Dihydrochloride Monohydrate

Drug: Jaktinib Dihydrochloride Monohydrate

group 2

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

Jaktinib Dihydrochloride Monohydrate DRUG

Active Substance

Also known as: Jaktinib

group 1

placebo DRUG

Placebo

Also known as: PLA

group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions;
• Be able to complete the research according to the clinical trial protocol;
• Subjects (include male subjects) have no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures;
• Male and female subjects between 18 and 45 years (inclusive) of age;
• The weight of a male subject is no lower than 50kg,The female is no lower than 45kg,and having a Body Mass Index (BMI) between 18 to 28 (both inclusive), calculated as weight in kg / height in m2;
• Health status: no clinical histories with clinical significance about heart, liver, kidney, digestive tract, nervous system, respiratory system (such as asthma), mental disorders and metabolic abnormalities and so on;
• Physical examination, vital signs normal or no clinical significance.

You may not qualify if:

• Someone smoking more than 5 pieces per day within the 3 months before the trial ；
• Allergies, such as allergies to Investigational Drug,excipients,or idiosyncratic reaction to drug and food;
• Having a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 units = beer 285 mL, or 25 mL of spirits, or 100 mL of wine)；
• Blood donation or extensive blood loss (\> 450 mL) within three months of the use of the study drug;
• Having difficulty of swallowing or any history of gastrointestinal diseases that affect drug absorption;
• Suffering from any increased risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc.;
• Taked any drug that changes liver enzyme activity 28 days prior to the use of the study drug;
• Taked any prescription, OTC drugs, any vitamin products or herbs within 14 days prior to the use of the study drug;
• Two weeks before the trial took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, and other activities that affect drug absorption, distribution, metabolism, excretion and so on;
• Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers, such as itraconazole, ketoconazole or dronedarone;
• There have been significant changes in diet or exercise habits recently;
• Taked research drugs within three months prior to the use of the study drug or participating in any drug clinical trial;
• Subjects who were intolerant of high-fat meals (2 boiled eggs, 100g, 20g Bacon, 1 slices of buttered toast, 50g, 115g fries, and 240 ml whole milk) were applied only to subjects who participated in the postprandial test.
• ECG has clinical significance;
• Female subjects are in lactation or serum pregnancy test are positive during screening or during the test;

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, China

Location

Study Officials

• Yanhua Ding, MD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SAD: 8 cohorts, 8 subjects take jaktinib and 2 subjects take placebo; MAD: 5 cohorts, 8 subjects take jaktinib and 2 subjects take placebo; Postprandial Phamocokinetics:12 subjects, crossover designing

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 19, 2017
• Study Start: September 28, 2017
• Primary Completion: August 30, 2018
• Study Completion: September 27, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

CN (1)