Bioequivalence Study in Healthy SubjectsPhase 1NCT07675226

Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions

A Phase 1 study testing SKI-O-703 API in Capsules and SKI-O-703 Formulated Granules in Capsules in people with Bioequivalence Study in Healthy Subjects and Immune Thrombocytopenia (ITP), run by Oscotec Inc. at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP), Rheumatoid Arthritis (RA)
What is being tested?: SKI-O-703 API in Capsules and SKI-O-703 Formulated Granules in Capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteSouth Korea
Study dates: 10 Jul 2026to 31 Dec 2026
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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
Body mass index (weight [kg] / height2 [m]2) between 18 and 30 kg/m2, and body weight not less than 50 kg.
Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
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.
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.

Who cannot join

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)
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).
Unable to swallow multiple capsules by mouth.
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.
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.
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.

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History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.
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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Oscotec
Seongnam-si, Gyeonggi-do

Other trials in South Korea

About this study

Official title: An Open-label, Randomized, Fed, Single-dose, Oral Administration, 2-treatment, 2-period, Crossover Design, Phase 1 Clinical Trial to Evaluate the Bioequivalence of SKI-O-703 in Healthy Adult Participants

This is an open-label, randomized, crossover Phase 1 study to evaluate the bioequivalence, pharmacokinetics, and safety of two oral SKI-O-703 drugs (test and reference) in healthy adults under fed conditions. Approximately 48 Korean and Caucasian participants will receive a single oral dose of the test drug and a single oral dose of the reference drug in a randomized sequence, separated by a washout period, with pharmacokinetic sampling and safety assessments performed throughout the study.

Conditions: Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP), Rheumatoid Arthritis (RA)
Being tested: SKI-O-703 API in Capsules, SKI-O-703 Formulated Granules in Capsules
Medical subject headings: Purpura, Thrombocytopenic, Idiopathic, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SKI-O-703 API in CapsulesDrug
SKI-O-703 API in Capsules 100mg
SKI-O-703 Formulated Granules in CapsulesDrug
SKI-O-703 Formulated Granules in Capsules 200mg

Study groups in NCT07675226
Study group	Role	What they receive
A group (reference drug → test drug)	Experimental	Participants receive the SKI-O-703 API in capsules 100mg (reference drug) in Period 1 and the SKI-O-703 Formulated Granules in capsules 200mg (test drug) in Period 2 under fed conditions, with a 7-day washout between periods. Receives: Drug: SKI-O-703 API in Capsules; Drug: SKI-O-703 Formulated Granules in Capsules
B group ( test drug → reference drug)	Experimental	Participants receive the SKI-O-703 Formulated Granules in capsules 200mg (test drug) in Period 1 and the SKI-O-703 API in capsules 100mg (reference drug) in Period 2 under fed conditions, with a 7-day washout between periods. Receives: Drug: SKI-O-703 API in Capsules; Drug: SKI-O-703 Formulated Granules in Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

To measure AUCt of SKI-O-592 (the free base of SKI-O-703)
Measured: Approximately 1 year
To measure Cmax of SKI-O-592 (the free base of SKI-O-703)
Measured: Approximately 1 year

Secondary outcomes (4)

To measure Tmax of SKI-O-592 (the free base of SKI-O-703)
Measured: Approximately 1 year
To measure t1/2 of SKI-O-592 (the free base of SKI-O-703)
Measured: Approximately 1 year
To measure Tmax of M2 and M4
Measured: Approximately 1 year
To measure t1/2 of M2 and M4
Measured: Approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 202631 Dec 2026

First posted30 Jun 2026
Study start10 Jul 2026
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bioequivalence Study in Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07675226
Sponsor's protocol ID: OSCO-P1205
Status last verified: Jun 2026
First submitted: 23 Jun 2026
Last updated: 1 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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