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

NCT06193148 | Completed Phase 1

• 1 other identifier: ZGJAK039
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Jaktinib 100mg

EXPERIMENTAL

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

Drug: Jaktinib; Drug: Placebo

Jaktinib 400mg

EXPERIMENTAL

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

Drug: Jaktinib; Drug: Placebo

Jaktinib 600mg

EXPERIMENTAL

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

Drug: Jaktinib; Drug: Placebo

Jaktinib 800mg

EXPERIMENTAL

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

Drug: Jaktinib; Drug: Placebo

Interventions

Jaktinib DRUG

Participants will receive Jaktinib orally for single dose

Jaktinib 100mg; Jaktinib 400mg; Jaktinib 600mg; Jaktinib 800mg

Placebo DRUG

Participants will receive Placebo orally for single dose

Jaktinib 100mg; Jaktinib 400mg; Jaktinib 600mg; Jaktinib 800mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhu, Jiangsu, China

Location

Study Officials

• LiYan Miao

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: March 19, 2024
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)