Status:
COMPLETED
A Study to Evaluate the Effect of Jaktinib on QT/QTc Interval in Healthy Participants
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Healthy Participants
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To evaluate the effect of Jaktinib Hydrochloride Tablets on QT/QTc interval in healthy subjects after a single oral administration.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06193148
Start Date
March 19 2024
End Date
June 18 2024
Last Update
December 12 2024
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhu, Jiangsu, China