Comparison of a Novel Leuprolide With Market Leuprolide

Study Overview
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Brief Summary
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This is a single dose, randomized, single blind, parallel group study to evaluate the testosterone suppressive effect in healthy male volunteers of a novel leuprolide acetate 3.75mg depot vs market reference leuprolide acetate 3.75mg depot. The safety, tolerability and the pharmacokinetic properties of the investigational drug and the control drug will also be assessed.

Official Title
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Evaluation of the Testosterone Suppressive Effect in Healthy Male Volunteers of a Novel Leuprolide Acetate 3.75mg Depot (Lutrate) VS Market Reference Leuprolide Acetate 3.75mg Depot (Enantone)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Lutrate
* Drug: Enantone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males of 18-40 years old (inclusive). The age difference of subjects within and between groups should be less than 10 years, at the time of screening. Body weight of at least 50kg. BMI to be 19-24 kg/m2 (inclusive). Able to comprehend the full nature and purpose of the study, including potential risks and side effects; able to cooperate with investigators and to comply with the requirements of the study Signed informed consent form prior to any screening procedures Exclusion Criteria: Clinically significant and relevant history of cardiovascular, hepatic, renal, hematologic, endocrine, respiratory, neurological diseases or acute/chronic diseases of the digestive tract. History of hypersensitivity towards leuprolide, synthetic LHRH or LHRH derivatives or any excipients of the study formulation. Abnormal and clinically significant 12-lead ECG Abnormal and clinically significant laboratory assessments Blood donation or blood loss greater than or equal to 400mL within 3 months prior to screening Participation of clinical trials within 3 months prior to screening Use of any drugs within 2 weeks prior to screening History of drug abuse within 1 year prior to screening History of alcohol abuse within 1 years prior to screening History of tobacco smoking (more than 5 cigarette per day) within 1 year prior to screening Abnormal testosterone level at screening (not in the range of 168-781ng/dL) Dermatitis or skin anomalies that might affect the administration area and the surroundings Subject or his partner not willing to adopt appropriate contraceptive measures Subjects have a history of depressive illness or sexual dysfunction; Subjects that the investigator deems unsuitable to be enrolled Subject not willing to cooperate with the investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lutrate<br>a novel leuprolide acetate 3.75mg depot | Drug: Lutrate<br>* a novel leuprolide acetate 3.75mg depot<br>|
| Active Comparator: Enantone<br>market reference leuprolide acetate 3.75 mg depot | Drug: Enantone<br>* market reference leuprolide acetate 3.75 mg depot<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of castration at the end of week 4 (i.e. day 29) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to castration (i.e Tlag) between the 2 groups after administration of leuprolide |  | 4 weeks | 
| The duration of castration (i.e Tcast) |  | 4 weeks | 
| LH concentration |  | 4 weeks | 
| FSH concentration |  | 4 weeks |