Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following SC Administration of DWJ108J in Patients With Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with prostate cancer

Official Title
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An Open Label, Randomized, Single Dose, Parallel-group, Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following Subcutaneous Administration of DWJ108J in Patients With Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Leuprolide Acetate
* Drug: Leuprolide Acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males ≥19 and ≤80 years of age at Screening. Subject with histologically proven adenocarcinoma of the prostate requiring androgen deprivation therapy An ECOG performance status grade of 0 to 2, 19kg/m2≤ Body Mass Index (BMI) ≤30kg/m2 at Screening. Exclusion Criteria: Confirmed Hormone refractory prostate cancer(HRPC) Has had history of bilateral orchiectomy, suprarenalectomy or hypophysectomy. Diagnosed pituitary adenoma Has a history of depression Has a risk of spinal cor d compression due to metastatic spinal cord injury. Has a severe urethratresia. Confirmed uncontrolled Congestive heart failure (CHF) within 6 months of Screening. Has a history of MI or any procedure with regard to coronary artery disease within 6 months of Screening. (e.g., balloon angioplasty, coronary artery bypass graft) Has any severe concomitant disease that would interfere with the conduct of the study except for prostate cancer Has allergy history of leuprolide acetate, similar GnRH drugs or other medications (e.g., Aspirin, antibiotics) and/or has any allergic disease requiring treatment. Has received an investigational drug within 9 0days of Screening. Drug releasing is expected after administration of study drug, if subject received GnRH agonist for treatment of prostate cancer. Has other chemotherapy planned within 14weeks from administration of study drug, except for androgen deprivation therapy. Has no willing of using method of contraception throughout the study period. Systolic Blood Pressure < 90mmHg and/or ≥160mmHg or Diastolic Blood Pressure < 60mmHg and/or ≥100mmHg at Screening QTcF >450msec at Screening ECG. HbA1c level is high the upper limit of normal of reference range. Serum AST, ALT or Creatinine > 1.5times the upper limit of normal at Screening. Positive results of tests for hepatitis B, hepatitis C, HIV or syphilis. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWJ108J (leuprolide acetate)<br>DWJ108J (leuprolide acetate) | Drug: Leuprolide Acetate<br>* DWJ108J, SC injection, once(Day1)<br>* Other names: DWJ108J;|
| Active Comparator: Leuplin DPS Inj<br>Leuplin DPS Inj | Drug: Leuprolide Acetate<br>* Leuplin DPS Inj, SC injection, once(Day1)<br>* Other names: Leuplin DPS Inj;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) |  | Day 99 | 
| Area under the plasma concentration versus time curve (AUC) | AUC0-7, AUC7-28, AUC 0-42, AUCt, AUCinf | Day 99 |