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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ID120040002 A mg | Experimental | Single dose 8 volunteers will be administered ID120040002 Amg or placebo comparators (ID120040002: placebo = 6:2) |
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| ID120040002 Bmg | Experimental | Single dose 8 volunteers will be administered ID120040002 Bmg or placebo comparators (ID120040002: placebo = 6:2) |
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| ID120040002 Cmg | Experimental | Single dose 8 volunteers will be administered ID120040002 Cmg or placebo comparators (ID120040002: placebo = 6:2) |
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| 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) |
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| ID120040002 Emg | Experimental | Single dose 8 volunteers will be administered ID120040002 Emg or placebo comparators (ID120040002: placebo = 6:2) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID120040002 | Drug | Drug: ID120040002 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 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) | From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mi Yeoun Lee | Contact | 02-526-3114 | mylee22@ildong.com |
| Name | Affiliation | Role |
|---|---|---|
| SeungHwan Lee, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| ID120040002 Fmg | Experimental | Multiple dose 10 volunteers will be administered ID120040004 F mg or placebo comparators (ID120040002: placebo: 8:2) |
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| ID120040002 Gmg | Experimental | Multiple dose 10 volunteers will be administered ID120040004 G mg or placebo comparators (ID120040002: placebo: 8:2) |
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| ID120040002 Hmg | Experimental | Multiple dose 10 volunteers will be administered ID120040004 H mg or placebo comparators (ID120040002: placebo: 8:2) |
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| ID120040002 Img | Experimental | Multiple dose 10 volunteers will be administered ID120040004 I mg or placebo comparators (ID120040002: placebo: 8:2) |
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| Compound-X Jmg | Active Comparator | Multiple dose 8 volunteers will be administered compound-X J mg |
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| Compound-X | Drug | Drug: Compound-X |
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| Placebo comparator | Drug | Placebo comparator |
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