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Recruiting Phase 1 NCT07919314

NCT07919314 A Study to Evaluate the Effects of Therapeutic and Supratherapeutic Doses of KRP-S124 Compared to Placebo With Moxifloxacin on QTc Interval in Healthy Participants

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Clinical Trial Summary
NCT ID NCT07919314
Status Recruiting
Phase Phase 1
Sponsor Kyorin Pharmaceutical Co.,Ltd
Condition Healthy Participants
Study Type INTERVENTIONAL
Enrollment 40 participants
Start Date 2026-10-14
Primary Completion 2027-02-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 55 Years
Study Type INTERVENTIONAL
Interventions
KRP-S124 Low DosePlaceboMoxifloxacin

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 40 participants in total. It began in 2026-10-14 with a primary completion date of 2027-02-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This study is being done to see how KRP-S124 affects the electrical activity of the heart (known as the QTc interval \[QT interval corrected for heart rate\]) in healthy volunteers. This helps researchers check the heart safety of the study drug.

Eligibility Criteria

Inclusion Criteria: * Male or non-childbearing potential female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than or equal to (\>=) 18 and less than or equal to (\<=) 55 years of age, with body mass index (BMI) greater than (\>) 18.5 and less than (\<) 30.0 kilograms per square meter (kg/m\^2) and body weight \>=50.0 kilograms (kg) for males and \>=45.0 kg for females. * Female participants of non-childbearing potential should not donate ova for 90 days after the last dose. * Male participants (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first dose and for 90 days after the last dose. * Male participants must be willing not to donate sperm for 90 days after the last dose. * Able to understand the study procedures and provide signed informed consent to participate in the study. Exclusion Criteria: * Any clinically significant abnormal finding at physical examination at screening or Baseline (Day -1 of Period 1). * Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening. * Any of the following laboratory parameters above the upper limit of normal (ULN) values at Screening or Baseline (Day -1 of Period 1): alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl-transpeptidase (GGT), direct bilirubin and total bilirubin. Only abnormal values between 1-1.5 \* ULN may be repeated once for confirmation to below ULN. * Known allergic reactions to KRP-S124 or other related drugs, or to any excipient in the formulation. * Clinically significant vital signs abnormalities (systolic blood pressure lower than 90 or over 140 millimeters of mercury \[mmHg\], diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 beats per minute \[bpm\]) at screening or Baseline (Day -1 of Period 1). * History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening. * History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5 percent (%), 140 mL of wine 12%, or 45 mL of distilled alcohol 40%). * Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing (or 5 half-lives, whichever is longer), administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing (or 5 half-lives, whichever is longer), or concomitant participation in an investigational study involving no drug or device administration. * History of sustained and non-sustained cardiac arrhythmias (ECG demonstrated), family history of sudden cardiac death, and history of additional risk factors for Torsade-de-pointes, (e.g. \[for example\]: heart failure, hypokalemia, unexplained syncope, family history of Long QT Syndrome). * Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Contact & Investigator

Central Contact

Clinical Development Center Kyorin Pharmaceutical Co., Ltd.

✉ ml-kyorin_clinicaltrials.gov@mb.kyorin-pharm.co.jp

📞 +81-3-6368-4834

Frequently Asked Questions

Who can join the NCT07919314 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07919314 trial and what does that mean for participants?

Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.

Is NCT07919314 currently recruiting?

Yes, NCT07919314 is actively recruiting participants. Contact the research team at ml-kyorin_clinicaltrials.gov@mb.kyorin-pharm.co.jp for enrollment information.

Where is the NCT07919314 trial being conducted?

This trial is being conducted at Québec, Canada.

Who is sponsoring the NCT07919314 clinical trial?

NCT07919314 is sponsored by Kyorin Pharmaceutical Co.,Ltd. The trial plans to enroll 40 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: November 2026  ·  Data Methodology