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The goal of this study is to investigate the safety and tolerability of the topical application of SOF-SKN in healthy volunteers. The study will be divided into part 1 and part 2.
Part 1, is a single ascending dose (SAD) design, while Part 2 is a multiple ascending dose (MAD) design.
The study will contain four, single ascending dose-escalation cohorts and four multiple dose-escalation cohorts allowing an exploration of different doses of SOF-SKN with safety monitoring to ensure the safety of the participants.
A maximum of thirty-two (32) participants will be enrolled overall, with a maximum of sixteen (16) participants enrolled into each part of the study.
There is to be a 28-day Screening period (Day -28 to -1) for both Part 1 and 2 of the study.
Both SAD and MAD will include four treatment cohorts (0.25%, 0.5%, 1% and 2%) of SOF-SKN.
Participants enrolled Part 1 (SAD) will receive a single dose of 2 g Soft-SKN cream while the participants enrolled in Part 2 (MAD) will receive daily applications of 2 g SOF-SKN cream for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | Single application of 2 g SOF-SKN cream 2.5 mg/g (0.25% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
|
| Cohort 2 | Active Comparator | Single application of 2 g SOF-SKN cream 5 mg/g (0.5% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
|
| Cohort 3 | Active Comparator | Single application of 2 g SOF-SKN cream 10 mg/g (1% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
|
| Cohort 4 | Active Comparator | Single application of 2 g SOF-SKN cream 20 mg/g (2% w/w) applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF-SKN 0.25% | Drug | cream for topical application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Target Toxicities after a single treatment | Part 1: Percentage of Target Toxicities after a single application of study treatment | 4 days -3 days after last application of topical treatment |
| Percentage of Target Toxicities after two-week treatment | Part 2: Percentage of Target Toxicities following two weeks of daily application of study treatment | 17 days - 3 days after last dose of treatment |
| Percentage of Adverse events (AEs) after a single treatment | Part 1: Percentage of AEs after a single application of study treatment | 4 days -3 days after last application of topical treatment |
| Percentage of Adverse events (AEs) after two-week treatment | Part 2: Percentage of AEs following two weeks of daily application of study | 17 days - 3 days after last dose of treatment |
| Percentage of Serious Adverse events (SAEs) after a single treatment | Part 1: Percentage of SAEs after a single application of study treatment | 4 days -3 days after last application of topical treatment |
| Percentage of serious Adverse events (SAEs) after two-week treatment | Part 2: Percentage of SAEs following two weeks of daily application of study treatment. | 17 days - 3 days after last dose of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of a single application of SOF-SKN | To determine the MTD of a single application of SOF-SKN cream. | 4 days -3 days after last application of topical treatment |
| Maximum Tolerated Dose (MTD) for multiple applications of SOF-SKN |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gisela Mautner, MD-PhD | Contact | + 61 2 9144 2223 | medical.information@noxopharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doherty Clinical Trials | Recruiting | Melbourne | Victoria | Australia |
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| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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Double blind
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| Cohort 5 | Active Comparator | Multiple applications of 2 g SOF-SKN cream 2.5 mg/g (0.25% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
|
| Cohort 6 | Active Comparator | Multiple applications of 2 g SOF-SKN cream 5 mg/g (0.5% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
|
| Cohort 7 | Active Comparator | Multiple applications of 2 g SOF-SKN cream 10 mg/g (1% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
|
| Cohort 8 | Active Comparator | Multiple applications of 2 g SOF-SKN cream 20 mg/g (2% w/w) once a day over 14 days applied topically to 10 × 30 cm area on the left or right side of the participant's back. In addition, a single 2 g application of placebo cream, to serve as an intra-participant control, will be applied to a 10 × 30 cm area on the alternate side of the participant's back. |
|
| SOF-SKN 0.5% |
| Drug |
cream for topical application |
|
| SOF-SKN 1% | Drug | cream for topical application |
|
| SOF-SKN 2% | Drug | cream for topical application |
|
| Placebo | Drug | cream for topical application |
|
To determine the MTD of multiple applications following two weeks of daily application of study treatment with SOF-SKN cream. |
| 17 days - 3 days after last dose of treatment |
| Maximum concentration (Cmax) of a single application of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure. The Maximum concentration (Cmax) will be calculated, if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours) |
| Time to reach Cmax (tmax) of a single application of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure. Time to reach Cmax (tmax), if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours) |
| Area Under the Concentration-Time Curve (AUC) of a single application of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure. The Area Under the Concentration-Time Curve (AUC) will be calculated from Time Zero to the Last Measurable Plasma Concentration (AUC0-last), if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours) |
| AUC Extrapolated to Infinity (AUC0-inf) of a single application of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure. The AUC Extrapolated to Infinity (AUC0-inf) will be calculated, if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours) |
| Half-life (t1/2) of a single application of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure. The Half-life (t1/2) will be calculated, if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours) |
| Maximum concentration (Cmax) for multiple applications of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure The Maximum concentration (Cmax) will be calculated, if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17) |
| Time to reach Cmax (tmax) for multiple applications of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure The Time to reach Cmax (tmax) will be calculated, if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17) |
| Area Under the Concentration-Time Curve (AUC) for multiple applications of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure The Area Under the Concentration-Time Curve (AUC) Calculated from Time Zero to the Last Measurable Plasma Concentration (AUC0-last) will be calculated, if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17) |
| AUC Extrapolated to Infinity (AUC0-inf) for multiple applications of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure The AUC Extrapolated to Infinity (AUC0-inf) will be calculated, if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17) |
| Half-life (t1/2) for multiple applications of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure The Half-life (t1/2) will be calculated, if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17) |
| Drug Accumulation Ratio (Rac) for multiple applications of SOF-SKN | PK parameters will be calculated to determine the degree of systemic exposure The Drug Accumulation Ratio (Rac) will be calculated, if possible, as minimal systemic exposure is expected. | 7 timepoints from baseline to day 17 (baseline, Day 1, Day 2, Day 4, Day 7, Day 10, Day 14 and Day 17) |