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Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants

ConditionCutaneous Lupus Erythematosus
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorNoxopharm Limited

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy Volunteers 18 to 64 years.

Participants with Fitzpatrick skin type I to IV.

Participants must have a back surface area of at least 24 × 30 cm to accommodate two - 10 × 30 cm application areas with a 4 cm separation between them.

No Allergies.

Disqualifiers

Allergic constitution.

Within 72 hours of the start of study treatment, the use of antihistamines or use of topical drugs at the application site.

Hair removing interventions including laser treatment, shaving and waxing in the target area within 1 week before Screening.

Hypertrichosis on the back; no tattoos that cover greater than 30% of the back surface area.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SOF-SKN 0.25%

    Drug

    cream for topical application

  • 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

Treatment groups

32 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Cohort 1Active comparator 2 interventions
Group B: Cohort 2Active comparator 2 interventions
Group C: Cohort 3Active comparator 2 interventions
Group D: Cohort 4Active comparator 2 interventions
Group E: Cohort 5Active comparator 2 interventions
Group F: Cohort 6Active comparator 2 interventions
Group G: Cohort 7Active comparator 2 interventions
Group H: Cohort 8Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Target Toxicities after a single treatment

Part 1: Percentage of Target Toxicities after a single application of study treatment

Time frame
4 days -3 days after last application of topical treatment
2

Percentage of Target Toxicities after two-week treatment

Part 2: Percentage of Target Toxicities following two weeks of daily application of study treatment

Time frame
17 days - 3 days after last dose of treatment
3

Percentage of Adverse events (AEs) after a single treatment

Part 1: Percentage of AEs after a single application of study treatment

Time frame
4 days -3 days after last application of topical treatment
4

Percentage of Adverse events (AEs) after two-week treatment

Part 2: Percentage of AEs following two weeks of daily application of study

Time frame
17 days - 3 days after last dose of treatment

Secondary outcomes

1

Maximum Tolerated Dose (MTD) of a single application of SOF-SKN

To determine the MTD of a single application of SOF-SKN cream.

Time frame
4 days -3 days after last application of topical treatment
2

Maximum Tolerated Dose (MTD) for multiple applications of SOF-SKN

To determine the MTD of multiple applications following two weeks of daily application of study treatment with SOF-SKN cream.

Time frame
17 days - 3 days after last dose of treatment
3

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.

Time frame
7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)
4

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.

Time frame
7 timepoints from baseline to 24 hours (baseline, 30 mins, 1, 2, 4, 6 and 24 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Noxopharm Limited

Lead sponsor

Source ClinicalTrials.gov
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