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

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Post-surgery Adhesion Formation
Interventions
DRUG

PXL01

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.

DRUG

Placebo

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.

Trial Locations (1)

SE-582 25

Berzelius Clinical Research Center, Linköping

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaSurgics AB

INDUSTRY