Safety Study Investigating Local Tolerability and Pharmacokinetics of PXL01 in Healthy Volunteers

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PharmaSurgics AB

Criteria

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