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

Zelgen Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Jaktinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06193148

ZGJAK039

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups

Jaktinib 100mg

Experimental group

Description:

6 Participants will receive Jaktinib 100 mg, orally; 2 Participants will receive placebo, orally.

Treatment:

Drug: Placebo

Drug: Jaktinib

Jaktinib 400mg

Experimental group

Description:

6 Participants will receive Jaktinib 400 mg, orally; 2 Participants will receive placebo, orally.

Treatment:

Drug: Placebo

Drug: Jaktinib

Jaktinib 600mg

Experimental group

Description:

6 Participants will receive Jaktinib 600 mg, orally; 2 Participants will receive placebo, orally.

Treatment:

Drug: Placebo

Drug: Jaktinib

Jaktinib 800mg

Experimental group

Description:

6 Participants will receive Jaktinib 800 mg, orally; 2 Participants will receive placebo, orally.

Treatment:

Drug: Placebo

Drug: Jaktinib