Testing a new leukemia medication's heart safety in healthy volunteers

Plain-English translation of NCT07162116 on ClinicalTrials.gov ↗ · Source last updated September 2025 · Translation generated August 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new experimental medication called , which is being developed to treat a type of leukemia. Researchers want to understand how a single dose of this medication affects the heart's electrical activity in healthy volunteers. This is an important first safety step before the medication can be tested in patients who actually have the disease.

Before any new cancer medication can be given to patients, it must be carefully tested for safety. One concern with many medications is that they can sometimes affect the heart's electrical rhythm in dangerous ways. This study checks whether this medication causes those kinds of heart problems so doctors can decide if it is safe enough to move forward.

Do you qualify?

You likely qualify if…

you are between 18 and 45 years old
you are healthy with no serious medical conditions
you have a normal body weight (men at least 50 kg, women at least 45 kg) and a healthy BMI
you can attend study visits and follow all the study instructions
your physical exam, blood tests, heart rhythm test, and imaging scans are normal

You likely don't qualify if…

you have a serious medical condition affecting your heart, digestive system, lungs, kidneys, or mental health
you are allergic to fluoroquinolone antibiotics or any of the study medications
you have had major surgery in the past 6 months or donated blood in the past 3 months
you are taking prescription medications, over-the-counter drugs, herbal supplements, or vitamin products within 4 weeks of starting the study
you have a history of drug or alcohol abuse in the past 5 years

What participation looks like

If you qualify, you will be randomly assigned to one of three groups that will each receive a different dose of the medication (or a placebo or comparison drug). On the study day, after fasting overnight, you will take a single oral dose as instructed. You will then undergo heart monitoring (Holter monitor), have blood samples collected to measure how your body processes the medication, and be checked for any side effects. All of this occurs within a single visit, though you may need to return for follow-up safety checks.

AI-generated summary from trial data · Aug 11, 2026 · Not medical advice

Trial locations(1 site)

China

PKUCare Luzhong Hospital, Zibo, Shandong