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Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study of SKL24741 in Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by SK Life Science, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in part a, pre-dose and up to 240 hours post-dose plasma samples. in part b, days 1 and 7: pre-dose and up to 24 hours post-dose, days 3-6 and 9-13: pre-dose only, and day 14: pre-dose and up to 240 hours post-dose plasma samples

Summary

This trial tests a new drug, SKL24741, for safety in healthy adults. The study examines how the drug behaves under different conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in part a, pre-dose and up to 240 hours post-dose plasma samples. in part b, days 1 and 7: pre-dose and up to 24 hours post-dose, days 3-6 and 9-13: pre-dose only, and day 14: pre-dose and up to 240 hours post-dose plasma samples

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in part a, pre-dose and up to 240 hours post-dose plasma samples. in part b, days 1 and 7: pre-dose and up to 24 hours post-dose, days 3-6 and 9-13: pre-dose only, and day 14: pre-dose and up to 240 hours post-dose plasma samples

This trial's timeline: 3 weeks for screening, Varies for treatment, and in part a, pre-dose and up to 240 hours post-dose plasma samples. in part b, days 1 and 7: pre-dose and up to 24 hours post-dose, days 3-6 and 9-13: pre-dose only, and day 14: pre-dose and up to 240 hours post-dose plasma samples for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events (Incidence of treatment-emergent adverse events)

Clinically significant laboratory assessments

Columbia-Suicide Severity Rating Scale (Part B only)

+5 more

Secondary study objectives

Brain Diseases, Metabolic

AUC over the dosing interval (AUCτ) of SKL24741, SKL24742 (if appropriate), and possible metabolites (if deemed necessary) following the single and/or multiple dose administration of SKL24741

Brain Diseases, Metabolic

+6 more

Other study objectives

Fraction excreted unchanged in the urine (fe) of SKL24741, SKL24742 (if appropriate), and possible metabolites (if deemed necessary) following the single dose administration of SKL24741

Renal clearance (CLr) of SKL24741, SKL24742 (if appropriate), and possible metabolites (if deemed necessary) following the single dose administration of SKL24741

Trial Design

22Treatment groups

Experimental Treatment

Group I: Single Ascending Dose Level 9Experimental Treatment2 Interventions

4 Subjects will receive one dose of 1200 mg and 2 subjects will receive one dose of placebo

Group II: Single Ascending Dose Level 8Experimental Treatment2 Interventions

4 Subjects will receive one dose of 800 mg and 2 subjects will receive one dose of placebo

Group III: Single Ascending Dose Level 7Experimental Treatment2 Interventions

4 Subjects will receive one dose of 400 mg and 2 subjects will receive one dose of placebo

Group IV: Single Ascending Dose Level 6Experimental Treatment2 Interventions

4 Subjects will receive one dose of 300 mg and 2 subjects will receive one dose of placebo

Group V: Single Ascending Dose Level 5Experimental Treatment2 Interventions

4 Subjects will receive one dose of 200 mg and 2 subjects will receive one dose of placebo

Group VI: Single Ascending Dose Level 4Experimental Treatment2 Interventions

4 Subjects will receive one dose of 100 mg and 2 subjects will receive one dose of placebo

Group VII: Single Ascending Dose Level 3Experimental Treatment2 Interventions

4 Subjects will receive one dose of 50 mg and 2 subjects will receive one dose of placebo

Group VIII: Single Ascending Dose Level 2Experimental Treatment2 Interventions

4 Subjects will receive one dose of 25 mg and 2 subjects will receive one dose of placebo

Group IX: Single Ascending Dose Level 10Experimental Treatment2 Interventions

4 Subjects will receive one dose on the outcome of preceding dose levels and 2 subjects will receive one dose of placebo

Group X: Single Ascending Dose Level 1Experimental Treatment2 Interventions

4 Subjects will receive one dose of 10 mg and 2 subjects will receive one dose of placebo

Group XI: Optional Formulation Effect CohortExperimental Treatment1 Intervention

Up to 12 male subjects will be treated with the maximum daily dose tested in Part A using open-label, two period, two-sequence crossover design.

Group XII: Optional Food Effect CohortExperimental Treatment1 Intervention

Up to 12 male subjects will undergo an open-label, two period, two-sequence crossover design at the maximum daily dose tested in Part A.

Group XIII: Multiple Ascending Dose Level 8Experimental Treatment2 Interventions

6 Subjects will receive one dose each day (using tablet formulation instead of capsule formulation\*) for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose). \*Tablet formulation is utilized, instead of capsule formulation, in the marked dose levels.

Group XIV: Multiple Ascending Dose Level 7Experimental Treatment2 Interventions

6 Subjects will receive one dose of 2000 mg each day (using tablet formulation instead of capsule formulation\*) for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose). \*Tablet formulation is utilized, instead of capsule formulation, in the marked dose levels.

Group XV: Multiple Ascending Dose Level 6Experimental Treatment2 Interventions

6 Subjects will receive one dose of 1200 mg each day (using tablet formulation instead of capsule formulation\*) for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose). \*Tablet formulation is utilized, instead of capsule formulation, in the marked dose levels.

Group XVI: Multiple Ascending Dose Level 5Experimental Treatment2 Interventions

6 Subjects will receive one dose of 1200 mg each day for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).

Group XVII: Multiple Ascending Dose Level 4Experimental Treatment2 Interventions

6 Subjects will receive one dose of 800 mg each day for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).

Group XVIII: Multiple Ascending Dose Level 3Experimental Treatment2 Interventions

6 Subjects will receive one dose of 400 mg each day for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).

Group XIX: Multiple Ascending Dose Level 2Experimental Treatment2 Interventions

6 Subjects will receive one dose of 200 mg each day for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).

Group XX: Multiple Ascending Dose Level 1Experimental Treatment2 Interventions

6 Subjects will receive one dose of 50 mg each day for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose).

Group XXI: Gender Effect CohortExperimental Treatment1 Intervention

6 female subjects of non-childbearing potential will receive one dose of 50 mg under fasting conditions.

Group XXII: Food Effect CohortExperimental Treatment1 Intervention

After completing the fasting Single Ascending Dose escalation, the same 6 subjects who received one dose of 50 mg under fasting conditions will return to the clinic after a washout period for a second confinement to receive a second dose (same as fasting) under fed conditions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SKL24741

2020

Completed Phase 1

~120

Placebo

1995

Completed Phase 3

~2670