Healthy volunteers test new Brain-Targeting drug in early safety study
NCT ID NCT03655873
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug called HEC30654AcOH in 43 healthy adults to see if it is safe and how the body processes it. Participants received either single or multiple doses of the drug. The goal was to check for side effects and measure drug levels in the blood, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
43 people
The number who actually took part.
- Started
-
Nov 2018
- Finished
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Dec 2019
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * signing informed consent, and fully understanding the study's content, process,possible adverse reaction before the study beginning. * Be able to complete the study in accordance with the requirements of the study. * Subjects (including partner) which from screening to the last time of study drug dosage volunteered to take effective contraceptive measures within 6 months, see appendix for birth control measures. * Age of 18 to 45 years old male and female subjects (including 18 and 45 years of age). * Male subjects not less than 50 kg, female subjects not less than 45 kg weight.Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index (BMI) within the scope of 18 \~ 28 kg/m2 (including threshold). * Physical examination, vital signs is normal or abnormal has no clinical significance. Exclusion Criteria: * 3 months before the study daily smoking more than 5 pieces. * having allergies or allergic constitution for experiment drugs (a variety of drugs and food allergies). * Has a history of drug and/or binge drinking (drinking 14 units of alcohol every week: 1 unit = 285 mL beer, or liquor 25 mL, or wine 100 mL). * Three months before screening blood or blood loss (\> 450 mL). * 28 days before the screening taking any drugs of changing liver enzymes. * Within 14 days before the screening taken any prescription drugs, over-the-counter drugs, vitamins or herbal products. * Within 2 weeks before the screening taking any special diet (including dragon fruit, mango, pomelo, etc.) or with vigorous exercise, or other affect drug absorption, distribution, metabolism and excretion. * With the following CYP3A4, P - gp or Bcrp inhibitors or inducers, such as itraconazole, ketone health zun or definitely nida, lung, etc. * Recently, very large changes in diet or exercise habits. * Three months before taking study drug, there taken study drug and its analogues, or participated in drug clinical trials. * Having difficulty swallowing or any digestive system diseases history affecting drug absorption, excretion,etc. * Having had any increased risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc. * Abnormal ecg that have clinical significance. * Female subjects in screening test is in lactation or have positive serum pregnancy outcomes. * Clinical laboratory examination were abnormal clinical significance, or other clinical findings show that there are clinical significance of the following diseases (including but not limited to the gastrointestinal tract, liver, kidney, and nerve, blood, endocrine, tumor, lung, immune, spirit, or disease of heart head blood-vessel). * Viral hepatitis (including hepatitis b and c),, treponema pallidum antibody , HIV antibody positive. * From the screening stage to study medicine had a acute disease or taken a drugs. * Within 48 hours before taking the study drug, there taken any caffeine consumed chocolate, or rich xanthine food or drinks. * Within 24 hours before taking study drug, there used any alcoholic products or alcohol-breath test was positive. * Urine drug test(Morphine and marijuana) was positive. * Neurological examination had abnormal findings, and researchers think have clinical significance. * Researchers think that doesn't fit to the study.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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First Hospital of Jilin University
Changchun, Jilin, 130000, China
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