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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Jaktinib; Drug: Placebo

• Registration Number: NCT06193148
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2024-01-05
• Study Start: 2024-03-19
• Primary Completion: 2024-06-18
• Study Completion: 2024-06-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaktinib 100mg	Placebo	6 Participants will receive Jaktinib 100 mg, orally; 2 Participants will receive placebo, orally.
Jaktinib 600mg	Placebo	6 Participants will receive Jaktinib 600 mg, orally; 2 Participants will receive placebo, orally.
Jaktinib 400mg	Placebo	6 Participants will receive Jaktinib 400 mg, orally; 2 Participants will receive placebo, orally.
Jaktinib 800mg	Placebo	6 Participants will receive Jaktinib 800 mg, orally; 2 Participants will receive placebo, orally.
Jaktinib 100mg	Jaktinib	6 Participants will receive Jaktinib 100 mg, orally; 2 Participants will receive placebo, orally.
Jaktinib 400mg	Jaktinib	6 Participants will receive Jaktinib 400 mg, orally; 2 Participants will receive placebo, orally.
Jaktinib 600mg	Jaktinib	6 Participants will receive Jaktinib 600 mg, orally; 2 Participants will receive placebo, orally.
Jaktinib 800mg	Jaktinib	6 Participants will receive Jaktinib 800 mg, orally; 2 Participants will receive placebo, orally.

Primary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhu, Jiangsu, China