New cough combo drug tested in healthy people for first time
NCT ID NCT07161180
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-phase trial is testing a new combination drug called PBK_M2301, which contains two ingredients: levodropropizine (a cough suppressant) and Pelargonium sidoides extract (a herbal remedy). The study involves 32 healthy adults aged 19 to 64. Each person will take the combination drug and the two ingredients separately at different times, with a week break in between. The goal is to measure how the drug moves through the body and check for any safety issues.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PBK_M2301 (a tablet combining levodropropizine and Pelargonium sidoides extract)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Nov 2025
An estimate. End dates often move.
- Lead sponsor
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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
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19 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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.
1 Inclusion Criteria Subjects who meet all of the following criteria may be included in the study: 1. Male or female subjects aged 19 years or older and less than 65 years at the time of screening. 2. Body mass index (BMI) between 18 and 30 kg/m² (inclusive) at screening (BMI = weight (kg) / height (m)²): * For male subjects: body weight ≥ 50 kg. * For female subjects: body weight ≥ 45 kg. 3. No clinically significant congenital or chronic diseases, and no pathological symptoms or findings based on internal medicine examination (including, if necessary, electroencephalography, electrocardiography, chest and/or upper gastrointestinal endoscopy, or gastrointestinal radiographic examination). 4. Judged by the principal investigator (or a sub-investigator) to be suitable for participation based on diagnostic tests performed according to the characteristics of the investigational product, including hematology, clinical chemistry, coagulation, serology, urinalysis, and electrocardiography (ECG). 5. Voluntarily decides to participate after receiving and fully understanding a detailed explanation of the study, and signs the written informed consent form, agreeing to comply with the study requirements during the study period. 6. Agrees to use medically acceptable contraception\* (excluding hormonal contraceptives) from the first administration of the investigational product until 1 week after the last administration, to prevent pregnancy in themselves or their spouse/partner, and agrees not to donate sperm or ova during this period. * Medically acceptable contraception: intrauterine device (IUD), intrauterine system (IUS), vasectomy, tubal ligation, or a combination of barrier methods (male condom, female condom, cervical cap, diaphragm, contraceptive sponge). When using spermicide, at least two barrier methods should be used in combination. 2 Exclusion Criteria Subjects who meet any of the following criteria will be excluded from the study: 1. Use of enzyme-inducing or enzyme-inhibiting drugs such as barbiturates within 30 days prior to the first administration, or use of any drugs that may interfere with the study within 10 days prior to the first administration. 2. Participation in a bioequivalence study or any other clinical trial and administration of an investigational product within 6 months prior to the first administration in this study. 3. Whole blood donation within 8 weeks, component blood donation within 2 weeks, or receipt of a blood transfusion within 4 weeks prior to the first administration in this study. 4. History of gastrointestinal resection surgery that may affect drug absorption (excluding appendectomy or hernia repair). 5. Within 1 month prior to the first administration: * For male subjects: average alcohol consumption \> 21 units/week. * For female subjects: average alcohol consumption \> 14 units/week. (1 unit = 50 mL soju, 250 mL beer, or 30 mL whisky) * Average smoking \> 20 cigarettes/day. 6. Presence of the following conditions: * Known hypersensitivity to the investigational product or any of its components. * Bronchial hypersecretion. * Mucociliary dysfunction (e.g., Kartagener syndrome, primary ciliary dyskinesia). * Increased bleeding tendency or use of anticoagulant therapy. * Severe hepatic impairment. * Severe liver disease or severe renal disease. * Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 7. History of clinically significant psychiatric disorders. 8. Any other reason, not specified in the inclusion/exclusion criteria, that in the opinion of the principal investigator (or a sub-investigator) makes the subject unsuitable for participation. 9. For female subjects: pregnant, suspected of being pregnant, or breastfeeding.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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H+ Yangji Hospital
RECRUITINGSeoul, Seoul, 08799, South Korea
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