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

NCT00860080 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2010-04-23

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • PharmaSurgics AB

    lead INDUSTRY

Principal Investigators

  • Fredrik Huss, PhD · Berzelius Clinical Research Center

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Sweden

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860080 on ClinicalTrials.gov