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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193148
• Other study ID #: ZGJAK039
• Status: Recruiting
• Phase: Phase 1
• Start date: March 18, 2024
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Zhentian Zhao
• Phone: +86-0512-57309965
• Email: zhaozt[@]zelgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Jaktinib
Participants will receive Jaktinib orally for single dose
• Placebo
Participants will receive Placebo orally for single dose

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhu	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QT Interval Corrected Using Fridericia's Formula	Model-guided placebo-corrected change in QTcF from baseline (??QTcF)	From before dosing until 48 hours after dosing