Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

Study Overview
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Brief Summary
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In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects. And secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in healthy female subjects.

Detailed Description
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In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects. Secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in healthy female subjects.

Official Title
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A Phase I, Double-blind, Randomized, Placebo-controlled, Single-Dose Escalation, First-in-human Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SKI2670

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: SKI2670
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, 20 years of age and older Weight between 40kg 70kg Women who agreed using double contraception method and spermicide, avoiding breast-feeding for at least 30days after IP(investigational product) dosing A history of regular menstrual cycles (cycle: 28±7day, duration: 2 7day) for at least 2 years and a positive ovulation test between day 11 and 21 in the preceding menstrual cycle of IP(investigational product) dosing Exclusion Criteria: Women who are pregnant or serum/urine hCG(human chorionic gonadotropin) positive or breast-feeding A history of breast cancer, genital cancer or any estrogen dependent tumor Specified or unspecified diagnosed infertility or history of natural abortion over three times A history of taking other Investigational product within 60days before screening visit or taking ETC drug(Ethical drugs), oriental medicine or OTC drugs(Over-the-Counter drugs) within 14days before screening visit Clinically significant Gynecological disease identified by ultrasonography including estrogen dependent tumor or lesion, sever inflammation or synechia AST(Aspartate aminotransferase), ALT(Alanine aminotransferase) ≥ 2.5 times the upper limit of normal QTc > 450ms on electrocardiogram result

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SKI2670<br>Single-dose escalation/ Subjects received an oral single dose of SKI2670 capsule by dosing group -Dosing Group 1, Dosing Group 2, Dosing Group 3, Dosing Group 4 | Drug: SKI2670<br>* Oral, Single Dose<br>* Other names: N/A(only SKI2670);|
| Placebo Comparator: Placebo<br>Subjects received an oral single dose of placebo capsule matched to the SKI2670 dose (Placebo for SKI2670) | Drug: Placebo<br>* Same shape as the experimental drug<br>* Other names: N/A(only 1 Placebo);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | All participants who ever were administered with investigational product are assessed. | From day 1 to day 16 26D after a single oral dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of SKI2670 | Peak Plasma Concentration (Cmax) of SKI2670 | 0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h | 
| Area Under Curve (AUC) of SKI2670 | Area Under Curve (AUC) of SKI2670 | 0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h | 
| Concentration Change from Baseline(%) of Luteinizing Hormone (LH) | Concentration Change from Baseline(%) of Luteinizing Hormone (LH) | day -1, 0h(pre-dose), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 30h, 36h, 48h, 72h, day 7 12D, 16 26D |