A Study to Evaluate the Effect of Jaktinib on QT/QTc Interval in Healthy Participants

A Study to Evaluate the Effect of Oral Administration of Jaktinib Hydrochloride Tablets on QT/Corrected QT (QTc) Interval in Healthy Participants

To evaluate the effect of Jaktinib Hydrochloride Tablets on QT/QTc interval in healthy subjects after a single oral administration.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Jaktinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhentian Zhao; Phone Number: +86-0512-57309965; Email: zhaozt@zelgen.com

Study Locations

• China
  • Jiangsu
    • Suzhu, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Voluntarily sign informed consent, able to comply with the requirements of the study.
• Age 18-45 years old, both male and female;
• Weight: male ≥ 50 kg, female ≥ 45 kg, 19 kg/m^2 ≤ BMI ≤26 kg/m^2.
• 12-lead electrocardiogram (ECG) examination, 300 ms≤QTcF<450 ms, 120 ms≤PR interval ≤200 ms, and QRS duration <120 ms;
• The subjects (including male subjects) are willing to voluntarily take effective contraceptive measures within the next 3 months.

Exclusion Criteria:

• Have a history of risk factors for torsade de pointes, or have a family history of short QT syndrome, long QT syndrome, unexplained sudden death in young adulthood (≤40 years old), drowning or sudden infant death syndrome in first-degree relatives;
• Previous history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia;
• Subjects who had donated blood or lost ≥400 mL of blood within 3 months before screening;
• HBsAg, HCV antibody, HIV antibody, or TP antibody antibody positive.
• Women with positive blood pregnancy test (applicable to women) or lactating women;
• Subjects who have other factors that the investigator considers unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jaktinib 100mg; 6 Participants will receive Jaktinib 100 mg, orally; 2 Participants will receive placebo, orally.	Drug: Jaktinib; Participants will receive Jaktinib orally for single dose; Drug: Placebo; Participants will receive Placebo orally for single dose
Experimental: Jaktinib 400mg; 6 Participants will receive Jaktinib 400 mg, orally; 2 Participants will receive placebo, orally.	Drug: Jaktinib; Participants will receive Jaktinib orally for single dose; Drug: Placebo; Participants will receive Placebo orally for single dose
Experimental: Jaktinib 600mg; 6 Participants will receive Jaktinib 600 mg, orally; 2 Participants will receive placebo, orally.	Drug: Jaktinib; Participants will receive Jaktinib orally for single dose; Drug: Placebo; Participants will receive Placebo orally for single dose
Experimental: Jaktinib 800mg; 6 Participants will receive Jaktinib 800 mg, orally; 2 Participants will receive placebo, orally.	Drug: Jaktinib; Participants will receive Jaktinib orally for single dose; Drug: Placebo; Participants will receive Placebo orally for single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QT Interval Corrected Using Fridericia's Formula	Model-guided placebo-corrected change in QTcF from baseline (ΔΔQTcF)	From before dosing until 48 hours after dosing

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: LiYan Miao, The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ZGJAK039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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