A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers.

Not Applicable

Completed

• Conditions: Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism

• Registration Number: KCT0000968
• Lead Sponsor: iNtRON Biotechnology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

1. Healthy male subject whose age is 20 ~ 45 at the time of screening visit.
2. Body weight of =50kg and <90kg, while within ±20% of the ideal body weight. [ideal body weight(kg) = {height(cm)-100}x 0.9]
3. Subject agreed to participate in the trial and to follow all of trial-related rules with a full understanding, after having a full account of the trial

Exclusion Criteria

1. Present disease(s) or medical history(ies) which is(are) clinically significant on liver, heart, nervous system, respiratory system, hemato-oncology, cardiovascular or psychopathy.
2. Diagnosed or suspected infectious disease within 30 days in prior to the administration.
3. Clinically significantly allergic to drug(s) containing AI of N-Rephasin® SAL200 or to other drugs including aspirin and antibiotics, or has medical history(ies) on such allergy.
4. Already has taken other drug(s) containing AI of N-Rephasin® SAL200.
5. Positive for Antibody of N-Rephasin® SAL200.
6. SBP=90mmHg or DBP=50mmHg, otherwise, SBP=150mmHg or DBP=100mmHg in Vital sign which was measured after taking 3 minutes of resting in sitting position.
7. Has medical history of drug abuse or positive to drug abuse in urine drug screening.
8. Has taken any prescription drug(s) or herbal medicine(s) within 14 days prior to the administration, otherwise, any OTC(s) or vitamin(s) within 7 days prior to the administration(However, can participate in the study if investigator makes a decision that the subject can participate regardless the drug taken).
9. Has taken any other study drugs within 2 months prior to the administration.
10. Has donated blood(whole blood donation or component transfusion) within (2 months or 1 month, respectively) in prior to the administration, otherwise, has received blood transfusion within 1 month in prior to the administration.
11. Smoke at present or positive to metabolism of nicotine in urine test.
12. Drink regularly(over 21 units/week, 1 unit= 10 g of pure alcohol), otherwise, is not able to interrupt drinking and smoking in study period.
13. Investigator made a decision that the subject is not eligible based on results of laboratory test or other reason.
14. Not agree with contraception for 60days after the administration, otherwise, notification of pregnancy in case of his partner is pregnant for 90 days after the administration.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the safety of N-Rephasin® SAL200 in healthy human volunteers by 12 lead electrocardiogram, clinical lab values changes, monitoring of vital signs, and the occurrence of adverse events.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic evaluation of N-Rephasin® SAL200 at the administered doses by analysis of concentration of N-Rephasin® SAL200 in serum.