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The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IG001119 in Healthy Participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IG001119 Single Ascending Doses (SAD) | Experimental |
| |
| Placebo Single Ascending Doses (SAD) | Placebo Comparator |
| |
| IG001119 Multiple Ascending Doses(MAD) | Experimental |
| |
| Placebo Multiple Ascending Doses(MAD) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablets for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events(AE) |
| from ICF signing date to Day 10 |
| The incidence and severity of adverse events |
| from ICF signing date to Day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach the Peak Plasma Concentration (Tmax) | Plasma Pharmacokinetics (PK) parameter calculated using a non-compartmental model: tmax (h). | SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18 |
| Observed maximum concentration (Cmax) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX | Adelaide | South Australia | Australia, 5000 | Australia |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| IG001119 | Drug | Tablets for oral administration. |
|
Plasma PK parameter calculated using a non-compartmental model: Cmax (ng/mL).
| SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18 |
| Terminal elimination half-life (t1/2). | Plasma PK parameter calculated using a non-compartmental model: t1/2 (h) | SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18 |
| Area under the concentration-time curve (AUC). | Plasma PK parameter calculated using a non-compartmental model: AUC0-24h (h * ng/mL) | SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18 |
| Apparent clearance (CL/F). | Plasma PK parameter calculated using a non-compartmental model: CL/F (mL/h * kg). | SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18 |
| Apparent volume of distribution: Vd/F. | • Plasma PK parameter calculated using a non-compartmental model: Vd/F (mL/kg). | SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18 |
| Elimination rate constant (λz). | • Plasma PK parameter calculated using a non-compartmental model: λz (1/h). | SAD: From Day 1 to Day 5 MAD: From Day 1 to Day 18 |
| Pain tolerance time for the Cold Pain Test | Measure the duration of pain tolerance | Day 1 to Day 1 or Day 14 |