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

NCT01855048 | Completed Phase 1 Results DMC

• 1 other identifier: SAL200-1A
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single dose of N-Rephasin® SAL200 in healthy male subjects.

Conditions

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

Keywords

N-Rephasin® SAL200; endolysin; Placebo

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Safety of N-Rephasin® SAL200 in Healthy Human Volunteers

  Up to 50 days after administration

Other Outcomes (5)

• Pharmacokinetic Parameters After Single IV Administration of N-Rephasin® SAL200 [Effective t1/2 (h)]

  0, 4, 8, 12, 16, 20, 24 hours post-dose

• Pharmacodynamics Evaluation of N-Rephasin® SAL200 : Mean Concentration of Bactericidal Activity After Single Dose of N-Rephsin® SAL200 IV Administration

  up to 2hours

• Pharmacokinetic Evaluation of N-Rephasin® SAL200 at the Administered Doses by Analysis of Concentration of N-Rephasin® SAL200 in Serum [Cmax (µg/ml)]

  Day 1 to 2

Study Arms (2)

N-Rephasin® SAL200

EXPERIMENTAL

N-Rephasin® SAL200, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg

Biological: N-Rephasin® SAL200

INT200-Placebo

PLACEBO COMPARATOR

Placebo

Other: INT200-Placebo

Interventions

N-Rephasin® SAL200 BIOLOGICAL

continuous intravenous infusion over 60 minutes

N-Rephasin® SAL200

INT200-Placebo OTHER

Formulation buffer 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 subject whose age is 20 \~ 45 at the time of screening visit.
• Body weight of ≥50kg and \<90kg, while within ±20% of the ideal body weight. \[ideal body weight(kg) = {height(cm)-100}x 0.9\]
• 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

You may not qualify if:

• Present disease(s) or medical history(ies) which is(are) clinically significant on liver, heart, nervous system, respiratory system, haemato-oncology, cardiovascular or psychopathy.
• Diagnosed or suspected infectious disease within 30 days in prior to the administration.
• 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.
• Already has taken other drug(s) containing AI of N-Rephasin® SAL200.
• Positive for Antibody of N-Rephasin® SAL200.
• 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.
• Has medical history of drug abuse or positive to drug abuse in urine drug screening.
• Has taken any prescription drug(s) or herbal medicine(s) within 14 days prior to the administration, otherwise, any OTC(Over the counter) (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).
• Has taken any other study drugs within 2 months prior to the administration.
• 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.
• Smoke at present or positive to metabolism of nicotine in urine test.
• 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.
• Investigator made a decision that the subject is not eligible based on results of laboratory test or other reason.
• 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.

Sponsors & Collaborators

• Intron Biotechnology, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (6)

• Loessner MJ. Bacteriophage endolysins--current state of research and applications. Curr Opin Microbiol. 2005 Aug;8(4):480-7. doi: 10.1016/j.mib.2005.06.002.

  PMID: 15979390 RESULT

• Fischetti VA. Bacteriophage lysins as effective antibacterials. Curr Opin Microbiol. 2008 Oct;11(5):393-400. doi: 10.1016/j.mib.2008.09.012. Epub 2008 Oct 14.

  PMID: 18824123 RESULT

• Loeffler JM, Nelson D, Fischetti VA. Rapid killing of Streptococcus pneumoniae with a bacteriophage cell wall hydrolase. Science. 2001 Dec 7;294(5549):2170-2. doi: 10.1126/science.1066869.

  PMID: 11739958 RESULT

• Wu JA, Kusuma C, Mond JJ, Kokai-Kun JF. Lysostaphin disrupts Staphylococcus aureus and Staphylococcus epidermidis biofilms on artificial surfaces. Antimicrob Agents Chemother. 2003 Nov;47(11):3407-14. doi: 10.1128/AAC.47.11.3407-3414.2003.

  PMID: 14576095 RESULT

• Schellekens H. Immunogenicity of therapeutic proteins. Nephrol Dial Transplant. 2003 Jul;18(7):1257-9. doi: 10.1093/ndt/gfg164. No abstract available.

  PMID: 12808158 RESULT

• Jun SY, Jang IJ, Yoon S, Jang K, Yu KS, Cho JY, Seong MW, Jung GM, Yoon SJ, Kang SH. Pharmacokinetics and Tolerance of the Phage Endolysin-Based Candidate Drug SAL200 after a Single Intravenous Administration among Healthy Volunteers. Antimicrob Agents Chemother. 2017 May 24;61(6):e02629-16. doi: 10.1128/AAC.02629-16. Print 2017 Jun.

  PMID: 28348152 DERIVED

Related Links

• FDA, Guidance for Industry, Estimating the Maximum Safe Starting Dose inInitial Clinical Trials for Therapeutics in Adult Healthy Volunteers, 2005.

Results Point of Contact

• Title: Jun SooYoun, Ph.D. / Executive Director/ Principal researcher
• Organization: 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: May 3, 2013
• First Posted: May 16, 2013
• Study Start: August 6, 2013
• Primary Completion: February 7, 2014
• Study Completion: February 7, 2014
• Last Updated: November 3, 2021
• Results First Posted: November 3, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)