Safety Study Investigating Local Tolerability and Pharmacokinetics of PXL01 in Healthy Volunteers
Condition: Post-surgery Adhesion Formation
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine whether three different single doses of PXL01
      are safe and well tolerated by healthy volunteers. The pharmacokinetic properties of PXL01
      (same doses) will also be investigated.
    

Detailed description: 
      The primary objective is to investigate the local tolerability and safety of PXL01 in the
      doses 10, 20, 40 mg, and placebo. The secondary objective is to investigate the
      pharmacokinetic properties of PXL01 in single doses of 10, 20, and 40 mg.

      This is a single-blind, placebo-controlled, single dose administration study in male healthy
      volunteers. Each Subject will visit the centre three times; one screening visit, one dose
      administration visit and one follow-up visit over a period of approximately 3 weeks.

      At Visit 1 (screening visit), the Subject will be given verbal and written patient
      information and the informed consent will be signed. Thereafter, the Subject will be assessed
      for eligibility. Demography, concomitant medication, and medical history will be documented.
      A physical examination will be performed and blood/urine will be collected for safety
      analysis. Tests for HIV, Hepatitis B and C, drug screening and alcohol breath test will be
      performed. Vital signs and a 12-lead ECG will be recorded.

      At Visit 2 (dose administration visit), which will occur 7±3 days after the screening visit,
      the Subjects will first perform an alcohol breath test and PXL01/placebo will then be
      administered as an abdominal subcutaneous injection. Blood samples for pharmacokinetic
      analysis will be drawn, pulse and blood pressure will be recorded, and local tolerability
      assessments will be performed prior to and 15min, 30min, 45min, 60min, 1h 15min, 1h 30min,
      2h, 4h, 8h and 24h after the injection. A 12-lead ECG and body temperature will be recorded
      prior to dose, 1h, 2h, 4h, 8h and 24h after the injection. Blood will be collected prior to
      and 24 hours after the injection. Adverse Events (AEs) will be recorded and telemetry heart
      rythm will be monitored continuously. The Subjects will stay at the clinic for about 26 hours
      after the injection.

      Visit 3 (Follow-up visit) will be performed 5-8 days after Visit 2. A physical examination
      and local tolerability assessments will be performed. Vital signs, a 12-lead ECG and AEs will
      be recorded. Blood/urine will be collected for safety analysis.

      Each group will start by dosing two Subjects. One Subject will receive placebo and the other
      active treatment. If there are no safety/tolerability concerns within 48 hours, another three
      Subjects will receive the dose.

      Prior to dose escalation, a safety monitoring board will discuss all safety data. In case of
      any safety/tolerability concerns, dosing may be discontinued.
    

Intervention name(s): PXL01; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PXL01 is a synthetic peptide sequentially derived from human lactoferrin. The substance is formulated in a viscous solution of sodium hyaluronate. 10, 20, and 40 mg PXL01 will be administered as an abdominal subcutaneous injection of 0.5, 1, and 2 ml respectively.; Placebo is prepared by dilution of sodium hyaluronate using 0.9% sodium chloride solution. The concentration of sodium hyaluronate is 15 mg/ml after dilution. Placebo will be administered as an abdominal subcutaneous injection of 0.5, 1, and 2 ml respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: post-surgery adhesion formation