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.
Trial summary
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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
Show all 11Show fewer
- 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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Oscotec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07675226
- Acronym / sponsor ID
- OSCO-P1205
- Conditions
- Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP), Rheumatoid Arthritis (RA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Oscotec Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group (reference drug → test drug) | Experimental | Drug: SKI-O-703 API in Capsules, Drug: SKI-O-703 Formulated Granules in CapsulesParticipants 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. |
| B group ( test drug → reference drug) | Experimental | Drug: SKI-O-703 API in Capsules, Drug: SKI-O-703 Formulated Granules in CapsulesParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKI-O-703 API in CapsulesSKI-O-703 API in Capsules 100mg | Drug | A group (reference drug → test drug), B group ( test drug → reference drug) |
| SKI-O-703 Formulated Granules in CapsulesSKI-O-703 Formulated Granules in Capsules 200mg | Drug | A group (reference drug → test drug), B group ( test drug → reference drug) |
Primary outcome
To measure AUCt of SKI-O-592 (the free base of SKI-O-703)
Time frame: Approximately 1 year
To measure Cmax of SKI-O-592 (the free base of SKI-O-703)
Time frame: Approximately 1 year
4 secondary outcomes
To measure Tmax of SKI-O-592 (the free base of SKI-O-703)
Time frame: Approximately 1 year
To measure t1/2 of SKI-O-592 (the free base of SKI-O-703)
Time frame: Approximately 1 year
To measure Tmax of M2 and M4
Time frame: Approximately 1 year
To measure t1/2 of M2 and M4
Time frame: Approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Bioequivalence Study in Healthy Subjects
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
RecruitingPhase 1
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
Healthy
RecruitingPhase 1
A Phase 1 Study of Navlimetostat Tablet Formulations
Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure AUCt of SKI-O-592 (the free base of SKI-O-703) (time frame: Approximately 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.