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Completed

NCT Number: NCT06193148

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhu, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Jaktinib

Drug

Participants will receive Jaktinib orally for single dose

Placebo

Drug

Participants will receive Placebo orally for single dose

Primary outcomes

  1. QT Interval Corrected Using Fridericia's Formula

    Time frame: From before dosing until 48 hours after dosing

    Model-guided placebo-corrected change in QTcF from baseline (ΔΔQTcF)

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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