Healthy Adult SubjectsPhase 1NCT06635226
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects
A Phase 1 study testing ID110521156 in people with Healthy Adult Subjects, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- ID110521156
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2024to 19 Jun 2025
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 19 to 50 years at the time of Screening.
- Body mass index (BMI) within ≥27 kg/m2; and a total body weight ≥ 50 kg
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- For female subjects, not pregnant or lactation women, or naturally menopausal (spontaneous amenorrhea for at least 12 months) or surgically infertility (bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy etc).
Who cannot join
- Evidence or history of clinically significant hepatic, renal, neurological, immunological, pulmonary, gastrointestinal (including pancreatitis), endocrine, hematological, cardiovascular, urinary, psychiatric disease, sexual dysfunction or drug allergies.
- Treatment with an investigational drug (including a bioequivalence study) within 180 days prior to the scheduled date of first administration of the investigational product.
- Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 90 days after the last dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Seunghwan Lee, +82-2-741-4221
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administrations of ID110521156 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.
- Conditions
- Healthy Adult Subjects
- Being tested
- ID110521156, Placebo of 110521156
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID110521156Drug
ID110521156 capsules taken orally once daily
Placebo of 110521156Drug
ID110521156 placebo capsules taken orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) Receives: Drug: ID110521156; Drug: Placebo of 110521156 |
| Cohort 2 | Experimental | Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) Receives: Drug: ID110521156; Drug: Placebo of 110521156 |
| Cohort 3 | Experimental | Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) Receives: Drug: ID110521156; Drug: Placebo of 110521156 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs/serious AEs (SAEs)
Measured: Throughout study duration, up to 47 days
Secondary outcomes (16)
Maximum concentration of drug in plasma (Cmax)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: Day 1 and Day 28
Area under the plasma drug concentration-time curve during a dosing interval (AUCtau)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: Day 1 and Day 28
The time of peak concentration (Tmax)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: Day 1 and Day 28
Terminal half-life (t1/2)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: Day 1 and Day 28
Apparent clearance (CL/F)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: Day 1 and Day 28
Apparent volume of distribution after extravascular administration (Vd/F)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: Day 1 and Day 28
Renal clearance (CLR)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: Day 1 and Day 28
fe
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: Day 1 and Day 28
Trough plasma concentration taken directly before the next dose (Ctrough)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: Throughout study duration, up to 27 days
Minimum concentration of drug in plasma at steady state (Cmin, ss)
To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
Measured: Day 28
Average concentration of drug in plasma at steady state (Cavg, ss)
To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
Measured: Day 28
peak to trough fluctuation (PTF)
To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
Measured: Day 28
accumulation ratio (R)
To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
Measured: Day 28
Serum glucose
To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: up to 28 days
Insulin
To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.
Measured: up to 28 days
Hemoglobin A1c (HbA1c)
To assess the pharmacodynamics of ID110521156 when given at multiple ascending doses in healthy participants.
Measured: up to 47 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start13 Nov 2024
- Primary completion19 Jun 2025 (estimated)
- Study completion19 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- YUNOVIA CO.,LTD.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635226
- Sponsor's protocol ID
- ID110521156-T2DM-102
- Status last verified
- Dec 2024
- First submitted
- 2 Oct 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administrations of ID110521156 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06635226
- Acronym / sponsor ID
- ID110521156-T2DM-102
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- YUNOVIA CO.,LTD.
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 19 Jun 2025 (estimated)
- Study completion
- 19 Jun 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ID110521156, Drug: Placebo of 110521156Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) |
| Cohort 2 | Experimental | Drug: ID110521156, Drug: Placebo of 110521156Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) |
| Cohort 3 | Experimental | Drug: ID110521156, Drug: Placebo of 110521156Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects aged 19 to 50 years at the time of Screening.
- Body mass index (BMI) within ≥27 kg/m2; and a total body weight ≥ 50 kg
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- For female subjects, not pregnant or lactation women, or naturally menopausal (spontaneous amenorrhea for at least 12 months) or surgically infertility (bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy etc).
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hepatic, renal, neurological, immunological, pulmonary, gastrointestinal (including pancreatitis), endocrine, hematological, cardiovascular, urinary, psychiatric disease, sexual dysfunction or drug allergies.
- Treatment with an investigational drug (including a bioequivalence study) within 180 days prior to the scheduled date of first administration of the investigational product.
- Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 90 days after the last dose.
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 |
|---|---|---|
| ID110521156ID110521156 capsules taken orally once daily | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Placebo of 110521156ID110521156 placebo capsules taken orally once daily | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
AEs/serious AEs (SAEs)
Time frame: Throughout study duration, up to 47 days
16 secondary outcomes
Maximum concentration of drug in plasma (Cmax)
Time frame: Day 1 and Day 28
Area under the plasma drug concentration-time curve during a dosing interval (AUCtau)
Time frame: Day 1 and Day 28
The time of peak concentration (Tmax)
Time frame: Day 1 and Day 28
Terminal half-life (t1/2)
Time frame: Day 1 and Day 28
Apparent clearance (CL/F)
Time frame: Day 1 and Day 28
Apparent volume of distribution after extravascular administration (Vd/F)
Time frame: Day 1 and Day 28
Renal clearance (CLR)
Time frame: Day 1 and Day 28
fe
Time frame: Day 1 and Day 28
Trough plasma concentration taken directly before the next dose (Ctrough)
Time frame: Throughout study duration, up to 27 days
Minimum concentration of drug in plasma at steady state (Cmin, ss)
Time frame: Day 28
Average concentration of drug in plasma at steady state (Cavg, ss)
Time frame: Day 28
peak to trough fluctuation (PTF)
Time frame: Day 28
accumulation ratio (R)
Time frame: Day 28
Serum glucose
Time frame: up to 28 days
Insulin
Time frame: up to 28 days
Hemoglobin A1c (HbA1c)
Time frame: up to 47 days
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 24 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Healthy Subjects
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.
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 ID110521156 in people with Healthy Adult Subjects, run by IlDong Pharmaceutical Co Ltd 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Dec 2024. 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?
Contact Clinical Ops Study Leader (+82-10-4570-1405, eh.hong@yunovia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs/serious AEs (SAEs) (time frame: Throughout study duration, up to 47 days). 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 24 Dec 2024.