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

NCT ID: NCT06193148

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-19

Study Completion Date

2024-06-18

Brief Summary

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

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Jaktinib 100mg

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

Group Type EXPERIMENTAL

Jaktinib

Intervention Type DRUG

Participants will receive Jaktinib orally for single dose

Placebo

Intervention Type DRUG

Participants will receive Placebo orally for single dose

Jaktinib 400mg

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

Group Type EXPERIMENTAL

Jaktinib

Intervention Type DRUG

Participants will receive Jaktinib orally for single dose

Placebo

Intervention Type DRUG

Participants will receive Placebo orally for single dose

Jaktinib 600mg

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

Group Type EXPERIMENTAL

Jaktinib

Intervention Type DRUG

Participants will receive Jaktinib orally for single dose

Placebo

Intervention Type DRUG

Participants will receive Placebo orally for single dose

Jaktinib 800mg

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

Group Type EXPERIMENTAL

Jaktinib

Intervention Type DRUG

Participants will receive Jaktinib orally for single dose

Placebo

Intervention Type DRUG

Participants will receive Placebo orally for single dose

Interventions

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Jaktinib

Participants will receive Jaktinib orally for single dose

Intervention Type DRUG

Placebo

Participants will receive Placebo orally for single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LiYan Miao

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

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The First Affiliated Hospital of Soochow University

Suzhu, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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ZGJAK039

Identifier Type: -

Identifier Source: org_study_id