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
Verified date | April 2010 |
Source | PharmaSurgics AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Male healthy volunteers 2. Age = 18 to = 50 years 3. BMI = 18.5 to = 30.0 kg/m2 4. Signed written informed consent 5. Ability to co-operate Exclusion Criteria: 1. 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 2. Known allergy or hypersensitivity to PXL01, sodium hyaluronate, or structurally related compounds 3. Known allergies to avian proteins, feathers, and egg products 4. Enrolment in any other clinical study within 3 months prior to screening visit, or previous participation in the present study 5. Drug and/or alcohol abuse 6. Use of any nicotine containing products within one month prior to the screening visit 7. Scar tissue at the planned injection site 8. History of severe drug allergy or hypersensitivity as judged by the Investigator 9. Any planned major surgery within the duration of the study 10. Any other condition or symptoms preventing the Subject from entering the study, according to the Investigator's judgement 11. Donation of blood within 3 months prior to screening 12. Positive serology for HIV, hepatitis B, and/or hepatitis C viruses 13. Positive results on drug screening |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
Sweden | Berzelius Clinical Research Center | Linköping |
Lead Sponsor | Collaborator |
---|---|
PharmaSurgics AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety (the frequency and severity of adverse events, vital signs, haematology, clinical chemistry, urinalysis, electrocardiogram) and local tolerability (inspection of the injection site) | From dosing until 2 weeks after dosing | Yes | |
Secondary | The pharmacokinetic parameters Cmax, tmax, AUC, and t1/2 | 24 hours | No |