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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06193148

Enrollment

Registered

2024-01-05

Start date

2024-03-19

Completion date

2024-06-18

Last updated

2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief summary

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

Interventions

DRUGJaktinib

Participants will receive Jaktinib orally for single dose

DRUGPlacebo

Participants will receive Placebo orally for single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026