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Sponsor have decided to cancel the trial
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
| YUNOVIA CO.,LTD. | UNKNOWN |
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This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. This study is a dose-escalation study with healthy participants in single ascending dose (SAD) including food-effect and multiple ascending dose (MAD) cohorts to determine the highest allowable dose (HAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD: ID119031166M | Experimental |
| |
| MAD: ID119031166M | Experimental |
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| SAD: Placebo | Placebo Comparator |
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| MAD: Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID119031166M | Drug | The participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) | To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants. | From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration determined directly from the concentration- time profile (Cmax) | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants. | Day 1-4 for SAD and Day 1-17 for MAD |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical trials medical group/PAREXEL | Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| Placebo | Drug | The participant will receive a oral dose of Placebo. |
|
| Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax) | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants. | Day 1-4 for SAD and Day 1-17 for MAD |
| Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last) | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. | Day 1-4 for SAD and Day 1-17 for MAD |
| Dose-normalized Cmax | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. | Day 1-4 for SAD and Day 1-17 for MAD |
| Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24) | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. | Day 1-4 for SAD and Day 1-17 for MAD |
| Dose-normalized AUC0-last | To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. | Day 1-4 for SAD and Day 1-17 for MAD |
| D013568 |
| Pathological Conditions, Signs and Symptoms |