Will a new drug form work the same? study tests two versions of SKI-O-703
NCT ID NCT07675226
First seen Jun 30, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This study tests whether two different capsule forms of the experimental drug SKI-O-703 are absorbed similarly in the body. About 48 healthy adults (Korean and Caucasian) will take a single dose of each form on separate days, with blood samples taken to compare drug levels. The results will help determine which form to use in future studies for conditions like immune thrombocytopenia and rheumatoid arthritis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SKI-O-703
- What this could lead to
- If the two forms are shown to be equivalent, this could simplify manufacturing and dosing for future trials in immune thrombocytopenia and rheumatoid arthritis.
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients. The drug may not work as hoped in actual disease conditions, and side effects could emerge in later trials.
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
-
About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
-
Dec 2026
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 years and older
- 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.
Inclusion Criteria: 1. Korean or Caucasian adults aged 19 years and older at screening. Caucasian: An individual whose parents and grandparents are of European, North American, or Middle Eastern origin; who was born in Europe, North America, or West Asia; and who has resided outside these regions for less than 10 years 2. Body mass index (weight \[kg\] / height2 \[m\]2) between 18 and 30 kg/m2, and body weight not less than 50 kg. 3. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. 4. Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, blood coagulation test, urinalysis or urine drug test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents. 5. Must sign voluntarily an informed consent form indicating they understand the purpose of, procedures required for, and comply to the prohibitions and restrictions specified in the study and is willing to participate in the study. Exclusion Criteria: 1. Any significant surgical/medical procedure or trauma within 4 weeks before the planned first dose of the study drug or history of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair) 2. Any current active infections, including localized infections, or any recent history (within 1 week prior to study drug administration) of active infections (including severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\], cough or fever, or a history of recurrent or chronic infections). 3. Unable to swallow multiple capsules by mouth. 4. Received an experimental drug within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled. Prior experience of participating in another clinical trial within 6 months before the planned first dose of the study drug. 5. Individuals who have dietary habits that may influence the absorption, distribution, metabolism, or excretion of the investigational product or who consume foods known to affect drug metabolism. 6. Before the start of the study (first day of administration) those who have donated whole blood or blood components within 8 weeks or within 2 weeks, respectively, or received a blood transfusion within 1 month, or cannot refrain from donating blood from the time of written consent until the end of the trial. 7. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening. 8. Individual unable to abstain from alcohol-, caffeine-, or xanthine-containing products within 72 hours before the first dose of study drug and during the study or who tested positive for drug abuse, alcohol at screening or check-in (Day -1). 10\) Smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarrets, or inhalers) within 30 days before the first dose of study drug or who tested positive for cotinine(indicating active current smoking) at screening or check-in (Day -1) 11) Individuals with hypersensitive to investigational product or components of investigational product 12) A women who are pregnant or suspected of being pregnant or breastfeeding. 13) Participants who do not consent to use medically acceptable methods of contraception\* to eliminate the possibility of pregnancy from the date of the first dose until 1 month after the last dose of the study drug. \*Combined use of an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or a combination of at least two barrier methods with spermicide. 14\) Individuals with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
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Conditions
The condition(s) this trial relates to.
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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Oscotec
Seongnam-si, Gyeonggi-do, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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