Status:
COMPLETED
A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers
Lead Sponsor:
Intron Biotechnology, Inc.
Conditions:
Healthy Volunteers
Anti-Bacterial Agents
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of N-Rephasin® SAL200 following single and multiple ascending doses in healthy male volunteers after continuous intravenou...
Detailed Description
* Forty subjects will be randomly assigned to receive either N-Rephasin® SAL200 injection or a placebo administered by a 60-min intravenous infusion. Within each group, 8 subjects (6 active and 2 plac...
Eligibility Criteria
Inclusion
- Healthy male subjects aged between 20 and 45 years at screening
- Those whose body weight is between 50kg and 90kg, and BMI is between 18.0 and 27.0
- Subjects who have fully understood this clinical trial via detailed explanation, are willing to voluntarily participate in this study, and agree to give written informed consent and to follow all of trial-related rules.
Exclusion
- Those who have clinically significant liver, kidney, nervous system, endocrine system, respiratory system, hemato-oncology, cardiovascular system, mental diseases or past history.
- Those who have been diagnosed or suspected infectious disease within 30 days prior to the first dose of study medication
- Those who have history of hypersensitivity to drugs containing N-Rephasin® SAL200 or other drugs (aspirin and antibiotics)
- Those who have taken other drugs containing N-Rephasin® SAL200.
- Those who are antibody-positive to N-Rephasin® SAL200
- Those who have SBP \<90mmHg or DBP \<50mmHg (otherwise SBP \> 150mmHg or DBP \> 100mmHg) in vital signs, when measured after a 3-minute rest in sitting position.
- Those who have medical history of drug abuse or positive to urine drug screening
- Has taken any prescription drugs or herbal medicines within 14 days prior to first dose of study medication; otherwise, has taken over-the-counter drugs or vitamins within 7 days prior to the first dose of study medication (However, if other conditions are appropriate upon judgment of the investigator, the subject may participate in this study.)
- Those who has taken other study medications within 3 months prior to the study medication
- Those who have donated whole blood within 2 months prior to the first dose of study medication or apheresis within 1 month, or received blood transfusion within 1 months prior to the first dose of study medication
- Those who smoke cigarettes or are found to be nicotine metabolite-positive in urinalysis
- Those who cannot continuously abstain from drinking alcohol (exceeding 21 units/week, 1 unit = 10g of pure alcohol) or smoking cigarettes during hospitalization
- Those who are judged ineligible for the clinical study by the investigator due to other reasons, including the results of clinical laboratory tests
- Those who do not agree to use medically accepted contraceptive measures for 60 days after the first dose of study medication, or those who are unwilling to report the partner's pregnancy until 90 days after the first dose of study medication
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03446053
Start Date
February 7 2018
End Date
February 7 2019
Last Update
November 3 2021
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744