A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers

NCT03446053 | Completed Phase 1 Results

• 1 other identifier: ITB-101_1b
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 intravenous infusion over 60 minutes.

Conditions

Healthy Volunteers; Anti-Bacterial Agents; Methicillin-Resistant Staphylococcus Aureus; Methicillin-Sensitive Staphylococcus Aureus Infection

Keywords

Methicillin-Resistant Staphylococcus Aureus; Methicillin-Sensitive Staphylococcus Aureus; N-Rephasin SAL200

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability Evaluation

  Monitoring of adverse events (AEs) for Safety and Tolerability Evaluation

  Up to 50D (±2D)

Other Outcomes (7)

• Pharmacokinetic Evaluation [Cmax (µg/mL)]

  Single administration: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post-dose Multiple administration: the above timepoints and 25, 36, 48, 49, 60, 72, 72.25, 72.5, 72.75, 73, 73.5, 74, 75, 76, 77, 78, 80, 82, 84, 96 hours post-dose

• Pharmacodynamic Evaluation

  Up to 2hours

• Immunogenicity Evaluation

  Up to 50D (±2D)

Study Arms (2)

N-Rephasin® SAL200

EXPERIMENTAL

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 placebo) will receive a single dose of 6 mg/kg, followed by multiple ascending dose of 3, 6, 9, and 12 mg/kg/day.

Biological: N-Rephasin® SAL200

INT200-Placebo

PLACEBO COMPARATOR

Saline

Other: INT200-Placebo

Interventions

N-Rephasin® SAL200 BIOLOGICAL

continuous intravenous infusion over 60 minutes

N-Rephasin® SAL200

INT200-Placebo OTHER

Formulation buffer except active ingredient for continuous intravenous infusion over 60 minutes

INT200-Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Intron Biotechnology, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (4)

• Etienne J, Fleurette J, Ninet JF, Favet P, Gruer LD. Staphylococcal endocarditis after dental extraction. Lancet. 1986 Aug 30;2(8505):511-2. doi: 10.1016/s0140-6736(86)90377-6. No abstract available.

  PMID: 2875256 BACKGROUND

• Kundsin RB. Documentation of airborne infection during surgery. Ann N Y Acad Sci. 1980;353:255-61. doi: 10.1111/j.1749-6632.1980.tb18928.x. No abstract available.

  PMID: 6939390 BACKGROUND

• van Hal SJ, Jensen SO, Vaska VL, Espedido BA, Paterson DL, Gosbell IB. Predictors of mortality in Staphylococcus aureus Bacteremia. Clin Microbiol Rev. 2012 Apr;25(2):362-86. doi: 10.1128/CMR.05022-11.

  PMID: 22491776 BACKGROUND

• Wire MB, Jun SY, Jang IJ, Lee SH, Hwang JG, Huang DB. A Phase 1 Study To Evaluate Safety and Pharmacokinetics following Administration of Single and Multiple Doses of the Antistaphylococcal Lysin LSVT-1701 in Healthy Adult Subjects. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0184221. doi: 10.1128/AAC.01842-21. Epub 2022 Jan 10.

  PMID: 35007129 DERIVED

Related Links

• Seung-Ho Han et al., Monitoring of Methicillin-Resistant Staphylococcus aureus in Nasal Swabs Obtained fron Dental Clinic Healthcare Providers and Medical Environments Nurses. Int J Oral Biology. 2010;35:7-12
• Eun Ja Park et al., Analysis of Economic Outcome of Methicillin-Resistant Staphylococcus aureus(MRSA) Bacteremia Using Retrospective Case-Control Study, Kor. J. Clin. Pharm 2007;17:59-64
• Hyuk Min Lee, Dong Eun Yong, Kyungwon Lee., Antimicrobial Resistance of Clinically Important Bacteria Isolated from 12 Hospitals in Korea in 2004 . Korean Journal of Clinical Microbiology 2005;8(1):66-73
• Frency J, Brun Y, Bes M, Meugnier H, Grimont F, Grimon PAD, Newi C, Fleurette J. Staphylococcus lugdunensis sp. and Staphylococcus schleiferi sp. novel two species from human clinical specimens. Int Syst Bacteriol. 1998;38:168-172

Results Point of Contact

• Title: Jun SooYoun, Ph.D. / Executive Director/ Principal researcher
• Organization: Institute of iNtRON Biotechnology

jsy@intron.co.kr

+82-31-739-5332

Study Officials

• In Jin Jang, M.D., Ph. D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: February 26, 2018
• Study Start: February 7, 2018
• Primary Completion: February 7, 2019
• Study Completion: February 7, 2019
• Last Updated: November 3, 2021
• Results First Posted: October 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)