Healthy Adult SubjectsPhase 1NCT06063291
Single Ascending Oral Dose Phase 1 Study 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 and pharmacokinetics of single oral doses of ID110521156 in healthy adult subjects. This is the first clinical study of ID110521156. 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
- 20 Nov 2023to 11 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18.5 to 29.9 kg/m2; and a total body weight ≥ 40 kg, ≤ 90 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 hematological, renal, endocrine, pulmonary, gastrointestinal(including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
- Treatment with an investigational drug (including a bioequivalence study) within 6 months prior to the scheduled date of 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 3 months after the last dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics After a Single Oral Administration of ID110521156 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of ID110521156 in healthy adult subjects. This is the first clinical study of ID110521156.
- Conditions
- Healthy Adult Subjects
- Being tested
- ID110521156, Placebo of ID110521156
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID110521156Drug
subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1
Placebo of ID110521156Drug
subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. Receives: Drug: ID110521156; Drug: Placebo of ID110521156 |
| Cohort 2 | Experimental | Cohort 2 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. Receives: Drug: ID110521156; Drug: Placebo of ID110521156 |
| Cohort 3 | Experimental | Cohort 3 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. Receives: Drug: ID110521156; Drug: Placebo of ID110521156 |
| Cohort 4 | Experimental | Cohort 4 will consist of 12 healthy subjects who will receive a single oral dose of ID110521156 at fed state and fasted state each. Receives: Drug: ID110521156 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs/serious AEs (SAEs)
Incidence and severity of ad adverse event
Measured: Throughout study duration, up to 9 days
Percentage of subjects with clinically significant change from baseline in vital signs, ECG, safety laboratory test results
Measured: Throughout study duration, up to 9 days
Secondary outcomes (10)
Maximum concentration (Cmax)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Measured: Throughout study duration, up to 9 days
Area under the plasma drug concentration-time curve from 0 to last, (AUClast)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Measured: Throughout study duration, up to 9 days
Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Measured: Throughout study duration, up to 9 days
The time of peak concentration,(Tmax)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Measured: Throughout study duration, up to 9 days
Terminal half-life (T1/2)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Measured: Throughout study duration, up to 9 days
Apparent clearance (CL/F)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Measured: Throughout study duration, up to 9 days
Apparent volume of distribution after extravascular administration (Vd/F)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Measured: Throughout study duration, up to 9 days
Amount excreted in urine (Ae)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Measured: Throughout study duration, up to 9 days
Renal Clearance (CLr)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Measured: Throughout study duration, up to 9 days
Fraction excreted unchanged of an administered dose (fe)
Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156
Measured: Throughout study duration, up to 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start20 Nov 2023
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
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 (actual)
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
- NCT06063291
- Sponsor's protocol ID
- ID110521156-T2DM-101
- Status last verified
- Nov 2024
- First submitted
- 13 Sep 2023
- Last updated
- 25 Nov 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics After a Single Oral Administration of ID110521156 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06063291
- Acronym / sponsor ID
- ID110521156-T2DM-101
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- YUNOVIA CO.,LTD.
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 2 Oct 2023 (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 and pharmacokinetics of single oral doses of ID110521156 in healthy adult subjects. This is the first clinical study of ID110521156.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ID110521156, Drug: Placebo of ID110521156Cohort 1 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. |
| Cohort 2 | Experimental | Drug: ID110521156, Drug: Placebo of ID110521156Cohort 2 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. |
| Cohort 3 | Experimental | Drug: ID110521156, Drug: Placebo of ID110521156Cohort 3 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. |
| Cohort 4 | Experimental | Drug: ID110521156Cohort 4 will consist of 12 healthy subjects who will receive a single oral dose of ID110521156 at fed state and fasted state each. |
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 18.5 to 29.9 kg/m2; and a total body weight ≥ 40 kg, ≤ 90 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 hematological, renal, endocrine, pulmonary, gastrointestinal(including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
- Treatment with an investigational drug (including a bioequivalence study) within 6 months prior to the scheduled date of 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 3 months 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 |
|---|---|---|
| ID110521156subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| Placebo of ID110521156subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1 | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
AEs/serious AEs (SAEs)
Time frame: Throughout study duration, up to 9 days
Incidence and severity of ad adverse event
Percentage of subjects with clinically significant change from baseline in vital signs, ECG, safety laboratory test results
Time frame: Throughout study duration, up to 9 days
10 secondary outcomes
Maximum concentration (Cmax)
Time frame: Throughout study duration, up to 9 days
Area under the plasma drug concentration-time curve from 0 to last, (AUClast)
Time frame: Throughout study duration, up to 9 days
Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf)
Time frame: Throughout study duration, up to 9 days
The time of peak concentration,(Tmax)
Time frame: Throughout study duration, up to 9 days
Terminal half-life (T1/2)
Time frame: Throughout study duration, up to 9 days
Apparent clearance (CL/F)
Time frame: Throughout study duration, up to 9 days
Apparent volume of distribution after extravascular administration (Vd/F)
Time frame: Throughout study duration, up to 9 days
Amount excreted in urine (Ae)
Time frame: Throughout study duration, up to 9 days
Renal Clearance (CLr)
Time frame: Throughout study duration, up to 9 days
Fraction excreted unchanged of an administered dose (fe)
Time frame: Throughout study duration, up to 9 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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 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: finished, as of the sponsor's last update on 25 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AEs/serious AEs (SAEs) (time frame: Throughout study duration, up to 9 days). 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 25 Nov 2024.