Status:
COMPLETED
Safety Study Investigating Local Tolerability and Pharmacokinetics of PXL01 in Healthy Volunteers
Lead Sponsor:
PharmaSurgics AB
Conditions:
Post-surgery Adhesion Formation
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief 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) wil...
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 ...
Eligibility Criteria
Inclusion
- Male healthy volunteers
- Age ≥ 18 to ≤ 50 years
- BMI ≥ 18.5 to ≤ 30.0 kg/m2
- Signed written informed consent
- Ability to co-operate
Exclusion
- Concomitant treatment with any drug within 7 days of dosing. This includes prescription and OTC drugs, as well as herbal medicines. Exceptions are occasional intake of paracetamol (maximum 1,500 mg/day; and not exceeding 3,000 mg/week) and nasal sprays, at the discretion of the Investigator
- Known allergy or hypersensitivity to PXL01, sodium hyaluronate, or structurally related compounds
- Known allergies to avian proteins, feathers, and egg products
- Enrolment in any other clinical study within 3 months prior to screening visit, or previous participation in the present study
- Drug and/or alcohol abuse
- Use of any nicotine containing products within one month prior to the screening visit
- Scar tissue at the planned injection site
- History of severe drug allergy or hypersensitivity as judged by the Investigator
- Any planned major surgery within the duration of the study
- Any other condition or symptoms preventing the Subject from entering the study, according to the Investigator's judgement
- Donation of blood within 3 months prior to screening
- Positive serology for HIV, hepatitis B, and/or hepatitis C viruses
- Positive results on drug screening
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00860080
Start Date
March 1 2009
End Date
April 1 2009
Last Update
April 23 2010
Active Locations (1)
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1
Berzelius Clinical Research Center
Linköping, Sweden, SE-582 25