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

EARLY_PHASE1COMPLETED

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Healthy Volunteers 18 to 64 years.
  2. Participants with Fitzpatrick skin type I to IV.
  3. 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.
  4. No Allergies.
  5. Contraception.
  6. Must be willing to abstain from the use of moisturizers and other topical applications on the back 24 hours prior and for the duration of the study.

Exclusion criteria

  1. Allergic constitution.
  2. Within 72 hours of the start of study treatment, the use of antihistamines or use of topical drugs at the application site.
  3. Hair removing interventions including laser treatment, shaving and waxing in the target area within 1 week before Screening.
  4. Hypertrichosis on the back; no tattoos that cover greater than 30% of the back surface area.
  5. Presence of an inflammatory dermatosis (including, but not limited to, atopic dermatitis, eczema, psoriasis, extensive acne), and/or suntan/burn that could interfere with the test field evaluation.
  6. Non-inflammatory skin lesions and changes (including, but not limited to, hyperpigmentation, multiple naevi, tattoos, blemishes, birthmarks, abrasions, ulcers, eschar, and/or scabs) present in the target area on the back that could interfere with the test field evaluation.
  7. Any history of or presence of in situ melanoma and non-melanoma skin cancer within the last 3 years.
  8. Any other skin disease or other visible skin condition noted on physical examination which in the Investigator's opinion might interfere with the evaluation of the test field reaction.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    EARLY_PHASE1

trial

Study ID

NCT07072611

Intervention or treatment

DRUG: SOF-SKN 0.25%

DRUG: SOF-SKN 0.5%

DRUG: SOF-SKN 1%

DRUG: SOF-SKN 2%

DRUG: Placebo

Conditions

  • Cutaneous Lupus Erythematosus

  • Condition: Cutaneous Lupus Erythematosus

  • DRUG: SOF-SKN 0.25% and other drugs

  • Melbourne, Victoria, Australia

  • Sponsor: Noxopharm Limited

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Research sites nearby

Closest Location:

Doherty Clinical Trials

Select from list below to view details:

  • Doherty Clinical Trials

    Melbourne, Victoria, Australia

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Who is running the clinical trial?

NL

Noxopharm Limited

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Cohort 1
  • 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.
Drug: SOF-SKN 0.25%, Drug: Placebo
    ACTIVE_COMPARATOR: Cohort 2
    • 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.
    Drug: SOF-SKN 0.5%, Drug: Placebo
      ACTIVE_COMPARATOR: Cohort 3
      • 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.
      Drug: SOF-SKN 1%, Drug: Placebo
        ACTIVE_COMPARATOR: Cohort 4
        • 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.
        Drug: SOF-SKN 2%, Drug: Placebo
          ACTIVE_COMPARATOR: Cohort 5
          • 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.
          Drug: SOF-SKN 0.25%, Drug: Placebo
            ACTIVE_COMPARATOR: Cohort 6
            • 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.
            Drug: SOF-SKN 0.5%, Drug: Placebo
              ACTIVE_COMPARATOR: Cohort 7
              • 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.
              Drug: SOF-SKN 1%, Drug: Placebo
                ACTIVE_COMPARATOR: Cohort 8
                • 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.
                Drug: SOF-SKN 2%, Drug: Placebo

                  What is the study measuring?

                  Primary Outcome

                  MeasureDescriptionTime Frame
                  Percentage of Target Toxicities after a single treatmentPart 1: Percentage of Target Toxicities after a single application of study treatment4 days -3 days after last application of topical treatment
                  Percentage of Target Toxicities after two-week treatmentPart 2: Percentage of Target Toxicities following two weeks of daily application of study treatment17 days - 3 days after last dose of treatment
                  Percentage of Adverse events (AEs) after a single treatmentPart 1: Percentage of AEs after a single application of study treatment4 days -3 days after last application of topical treatment
                  Percentage of Adverse events (AEs) after two-week treatmentPart 2: Percentage of AEs following two weeks of daily application of study17 days - 3 days after last dose of treatment
                  Percentage of Serious Adverse events (SAEs) after a single treatmentPart 1: Percentage of SAEs after a single application of study treatment4 days -3 days after last application of topical treatment
                  Percentage of serious Adverse events (SAEs) after two-week treatmentPart 2: Percentage of SAEs following two weeks of daily application of study treatment.17 days - 3 days after last dose of treatment

                  Secondary Outcome

                  MeasureDescriptionTime Frame
                  Maximum Tolerated Dose (MTD) of a single application of SOF-SKNTo 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-SKNTo 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-SKNPK 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-SKNPK 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-SKNPK 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-SKNPK 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-SKNPK 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-SKNPK 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-SKNPK 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-SKNPK 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-SKNPK 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-SKNPK 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-SKNPK 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)
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                  References

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

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