HealthyPhase 1NCT05663879
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of ID120040002 in Healthy Volunteers
A Phase 1 study testing ID120040002 and Compound-X in people with Healthy, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
A Randomized, Double-blinded, Partial-open, Placebo and Active-controlled, Single and Multiple Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ID120040002 and Compound-X
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Dec 2022to 31 Jul 2023
- 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
- Subjects who have a body weight of ≥50.0 kg to ≤90.0 kg, and Body Mass Index (BMI) of ≥18.0 kg/m2 to ≤27.0 kg/m2
- Subjects who have decided to voluntarily participate and consented in writing to comply with the precautions after listening to a detailed explanation of this clinical study
- Subjects who consent to use contraceptive methods* accepted in this trial with their partners and not to donate sperm until 90 days and eggs until 28 days after the administration of the last dose of the IP from the time of written consent.
Who cannot join
- Subjects with a history of clinically significant cardiovascular, respiratory, renal, endocrine, hematological, gastrointestinal, central nervous system, urinary, musculoskeletal and psychological disorders or malignant tumor, or current active diseases (however, subjects may be enrolled if the disease is completely recovered and does not affect the current health status)
- Subjects with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, hypochlorhydria, achlorhydria, etc.) or gastrointestinal surgery (excluding simple appendectomy and herniotomy) that can affect the absorption of the investigational product
- Subjects who have received the therapy for peptic ulcer, esophageal disease or Zollinger-Ellison syndrome within 90 days prior to the administration of the IP, or have clinically suspected symptoms of such diseases
- Subjects who have received H. pylori eradication therapy within 6 months, or have positive result for H. pylori test at screening
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
SeungHwan Lee, MD, PhD
SeungHwan Lee, MD, PhD
About this study
Official title: Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers
A Randomized, Double-blinded, Partial-open, Placebo and Active-controlled, Single and Multiple Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers
Read the detailed description
To evaluate the safety, tolerability, and pharmacokinetic characteristics and to explore pharmacodynamic characteristics and food effects after single and multiple doses of ID120040002 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- ID120040002, Compound-X, Placebo comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID120040002Drug
Drug: ID120040002
Compound-XDrug
Drug: Compound-X
Placebo comparatorDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| ID120040002 A mg | Experimental | Single dose 8 volunteers will be administered ID120040002 Amg or placebo comparators (ID120040002: placebo = 6:2) Receives: Drug: ID120040002; Drug: Placebo comparator |
| ID120040002 Bmg | Experimental | Single dose 8 volunteers will be administered ID120040002 Bmg or placebo comparators (ID120040002: placebo = 6:2) Receives: Drug: ID120040002; Drug: Placebo comparator |
| ID120040002 Cmg | Experimental | Single dose 8 volunteers will be administered ID120040002 Cmg or placebo comparators (ID120040002: placebo = 6:2) Receives: Drug: ID120040002; Drug: Placebo comparator |
| ID120040002 Dmg | Experimental | Period1:
Single dose 8 volunteers will be administered ID120040002 Dmg or placebo comparators (ID120040002: placebo = 6:2)
Period2:
Single dose 8 volunteers will be administered ID120040002 Dmg or placebo comparators (ID120040002: placebo = 6:2) Receives: Drug: ID120040002; Drug: Placebo comparator |
| ID120040002 Emg | Experimental | Single dose 8 volunteers will be administered ID120040002 Emg or placebo comparators (ID120040002: placebo = 6:2) Receives: Drug: ID120040002; Drug: Placebo comparator |
| ID120040002 Fmg | Experimental | Multiple dose 10 volunteers will be administered ID120040004 F mg or placebo comparators (ID120040002: placebo: 8:2) Receives: Drug: ID120040002; Drug: Placebo comparator |
| ID120040002 Gmg | Experimental | Multiple dose 10 volunteers will be administered ID120040004 G mg or placebo comparators (ID120040002: placebo: 8:2) Receives: Drug: ID120040002; Drug: Placebo comparator |
| ID120040002 Hmg | Experimental | Multiple dose 10 volunteers will be administered ID120040004 H mg or placebo comparators (ID120040002: placebo: 8:2) Receives: Drug: ID120040002; Drug: Placebo comparator |
| ID120040002 Img | Experimental | Multiple dose 10 volunteers will be administered ID120040004 I mg or placebo comparators (ID120040002: placebo: 8:2) Receives: Drug: ID120040002; Drug: Placebo comparator |
| Compound-X Jmg | Active comparator | Multiple dose 8 volunteers will be administered compound-X J mg Receives: Drug: Compound-X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Serious Adverse Events (SAEs)
To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.
Measured: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Number of participants with Adverse Events (AEs)
To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.
Measured: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Percentage of subjects with clinically significant change from baseline in vital signs
Measured: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG)
Measured: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start7 Dec 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungHwan Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663879
- Sponsor's protocol ID
- ID120040002-GERD-101
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05663879
- Acronym / sponsor ID
- ID120040002-GERD-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 23 Dec 2022 (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.
A Randomized, Double-blinded, Partial-open, Placebo and Active-controlled, Single and Multiple Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers
Detailed description
To evaluate the safety, tolerability, and pharmacokinetic characteristics and to explore pharmacodynamic characteristics and food effects after single and multiple doses of ID120040002 in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| ID120040002 A mg | Experimental | Drug: ID120040002, Drug: Placebo comparatorSingle dose 8 volunteers will be administered ID120040002 Amg or placebo comparators (ID120040002: placebo = 6:2) |
| ID120040002 Bmg | Experimental | Drug: ID120040002, Drug: Placebo comparatorSingle dose 8 volunteers will be administered ID120040002 Bmg or placebo comparators (ID120040002: placebo = 6:2) |
| ID120040002 Cmg | Experimental | Drug: ID120040002, Drug: Placebo comparatorSingle dose 8 volunteers will be administered ID120040002 Cmg or placebo comparators (ID120040002: placebo = 6:2) |
| ID120040002 Dmg | Experimental | Drug: ID120040002, Drug: Placebo comparatorPeriod1: Single dose 8 volunteers will be administered ID120040002 Dmg or placebo comparators (ID120040002: placebo = 6:2) Period2: Single dose 8 volunteers will be administered ID120040002 Dmg or placebo comparators (ID120040002: placebo = 6:2) |
| ID120040002 Emg | Experimental | Drug: ID120040002, Drug: Placebo comparatorSingle dose 8 volunteers will be administered ID120040002 Emg or placebo comparators (ID120040002: placebo = 6:2) |
| ID120040002 Fmg | Experimental | Drug: ID120040002, Drug: Placebo comparatorMultiple dose 10 volunteers will be administered ID120040004 F mg or placebo comparators (ID120040002: placebo: 8:2) |
| ID120040002 Gmg | Experimental | Drug: ID120040002, Drug: Placebo comparatorMultiple dose 10 volunteers will be administered ID120040004 G mg or placebo comparators (ID120040002: placebo: 8:2) |
| ID120040002 Hmg | Experimental | Drug: ID120040002, Drug: Placebo comparatorMultiple dose 10 volunteers will be administered ID120040004 H mg or placebo comparators (ID120040002: placebo: 8:2) |
| ID120040002 Img | Experimental | Drug: ID120040002, Drug: Placebo comparatorMultiple dose 10 volunteers will be administered ID120040004 I mg or placebo comparators (ID120040002: placebo: 8:2) |
| Compound-X Jmg | Active comparator | Drug: Compound-XMultiple dose 8 volunteers will be administered compound-X J mg |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects who have a body weight of ≥50.0 kg to ≤90.0 kg, and Body Mass Index (BMI) of ≥18.0 kg/m2 to ≤27.0 kg/m2
- Subjects who have decided to voluntarily participate and consented in writing to comply with the precautions after listening to a detailed explanation of this clinical study
- Subjects who consent to use contraceptive methods* accepted in this trial with their partners and not to donate sperm until 90 days and eggs until 28 days after the administration of the last dose of the IP from the time of written consent.
Key exclusion criteria (4 listed)
- Subjects with a history of clinically significant cardiovascular, respiratory, renal, endocrine, hematological, gastrointestinal, central nervous system, urinary, musculoskeletal and psychological disorders or malignant tumor, or current active diseases (however, subjects may be enrolled if the disease is completely recovered and does not affect the current health status)
- Subjects with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, hypochlorhydria, achlorhydria, etc.) or gastrointestinal surgery (excluding simple appendectomy and herniotomy) that can affect the absorption of the investigational product
- Subjects who have received the therapy for peptic ulcer, esophageal disease or Zollinger-Ellison syndrome within 90 days prior to the administration of the IP, or have clinically suspected symptoms of such diseases
- Subjects who have received H. pylori eradication therapy within 6 months, or have positive result for H. pylori test at screening
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 |
|---|---|---|
| ID120040002Drug: ID120040002 | Drug | ID120040002 A mg, ID120040002 Bmg, ID120040002 Cmg, ID120040002 Dmg, ID120040002 Emg, ID120040002 Fmg, ID120040002 Gmg, ID120040002 Hmg, ID120040002 Img |
| Compound-XDrug: Compound-X | Drug | Compound-X Jmg |
| Placebo comparatorPlacebo comparator | Drug | ID120040002 A mg, ID120040002 Bmg, ID120040002 Cmg, ID120040002 Dmg, ID120040002 Emg, ID120040002 Fmg, ID120040002 Gmg, ID120040002 Hmg, ID120040002 Img |
Primary outcome
Number of participants with Serious Adverse Events (SAEs)
Time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.
Number of participants with Adverse Events (AEs)
Time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.
Percentage of subjects with clinically significant change from baseline in vital signs
Time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG)
Time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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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.
SeungHwan Lee, MD, PhD principal investigator
Seoul National University Hospital
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 ID120040002 and Compound-X in people with Healthy, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mi Yeoun Lee (02-526-3114, mylee22@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Serious Adverse Events (SAEs) (time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)). The study lists 4 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 23 Dec 2022.