Post-surgery Adhesion Formation Clinical Trial
Official title:
A First in Man, Phase I, Single-blind, Placebo-controlled Study Investigating the Local Tolerability, Safety and Pharmacokinetics in Three Doses of PXL01 and Placebo in 15 Healthy Volunteers
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)