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A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers.
This study will be conducted in up to seven cohorts of Single Ascending Dose (SAD) & 3 cohorts of Multiple Ascending Dose (MAD). SAD will consist of a staggered dosing approach with a dose range from 1mg to 80mg. Staggered dosing approach will not be deployed for MAD cohorts with a dose range of 8mg to 40mg. In the MAD cohort, the effect of food will also be assessed by comparing the PK profile of Day 10 fed conditions against Day 14 fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohorts 1 to 6: Participants Receiving Placebo | Placebo Comparator | Participants in each SAD cohort will be randomized to receive placebo. |
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| SAD Cohorts 1 to 6: Participants receiving ECC0509 | Experimental | Participants in each SAD cohort will be randomized to receive 1 of 6 escalating doses (1 mg, 4 mg, 10 mg, 20 mg, 40 mg, or 60 mg). |
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| MAD Cohorts 1 to 4: Participants receiving Placebo | Placebo Comparator | Participants will be randomized to receive a once-daily dose of placebo for 14 days. |
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| MAD Cohorts 1 to 4: Participants receiving ECC0509 | Experimental | Participants will be randomized to receive a once-daily dose of 1 of 4 escalating doses (3 mg, 10 mg, 30 mg, 60 mg) for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching Placebo will be administered as oral capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations | Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination. | SAD: Up to Day 8. MAD: Up to Day 21. |
| Measure | Description | Time Frame |
|---|---|---|
| ECC0509 PK parameters: Cl/F | Apparent clearance | SAD: Up to Day 8. |
| ECC0509 PK parameters: Vz/F | Apparent volume of distribution | SAD: Up to Day 8. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001168 | Arthritis |
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| ECC0509 | Drug | ECC0509 1 mg and 10 mg capsules. ECC0509 will be administered as oral capsules. |
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| Placebo | Drug | Matching Placebo will be given orally during each dosing day. |
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| ECC0509 | Drug | ECC0509 1 mg and 10 mg capsules |
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| ECC0509 PK parameter: AUC0-24 | Area under the concentration-time curve from time zero to time 24 hours | MAD: Up to Day 21 |
| ECC0509 PK parameter: Cmax ss | Maximal observed concentration at steady-state | MAD: Up to Day 21 |
| ECC0509 PK parameter: Tmax ss | Time when the maximal concentration is observed at steady-state | MAD: Up to Day 21 |
| ECC0509 PK parameter: Tlag ss | Time prior to the first measurable (non-zero) concentration at steady-state | MAD: Up to Day 21 |
| ECC0509 PK parameters: Cmax | Maximal observed concentration | SAD: Up to Day 8. MAD: Up to Day 21 |
| ECC0509 PK parameter: Tmax | Time when the maximal concentration is observed | SAD: Up to Day 8. MAD: Up to Day 21 |
| ECC0509 PK parameter: AUC0-t | Area under the curve up to the last quantifiable time-point | SAD: Up to Day 8. MAD: Up to Day 21 |
| ECC0509 PK parameter: Cmin ss | Minimal observed concentration at steady-state | MAD: Up to Day 21 |
| ECC0509 PK parameter: T½ el | Terminal elimination half-life | SAD: Up to Day 8. MAD: Up to Day 21 |
| ECC0509 PK parameter: Kel | Terminal elimination rate constant | SAD: Up to Day 8. MAD: Up to Day 21 |
| ECC0509 PK parameter: Clss/F | Apparent body clearance at steady-state | MAD: Up to Day 21 |
| ECC0509 PK parameter: Vz ss/F | Apparent volume of distribution at steady-state | MAD: Up to Day 21 |
| ECC0509 PK parameter: AUC0-τ | Area under the concentration-time curve for one dosing interval (τ) at steady state. | MAD: Up to Day 21 |
| ECC0509 PK parameters: AUC0-inf | Area under the concentration-time curve from time zero to infinity | SAD: Up to Day 8. MAD: Up to Day 21 |
| ECC0509 PK parameters: Residual area | Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity | SAD: Up to Day 8. MAD: Up to Day 21 |
| PD Parameter: SSAO | plasma semicarbazide-sensitive amine oxidase (SSAO) activity. | SAD: Up to Day 8. MAD: Up to Day 21. |
| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |