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

NCT00860080 | Completed Phase 1 DMC

• 2 other identifiers: PHSU01EudraCT number: 2008-007506-11
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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) will also be investigated.

Conditions

Post-surgery Adhesion Formation

Keywords

post-surgery adhesion formation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The pharmacokinetic parameters Cmax, tmax, AUC, and t1/2

  24 hours

Study Arms (2)

PXL01

EXPERIMENTAL

Four Subjects per cohort will receive 10, 20, or 40 mg PXL01 respectively.

Drug: PXL01

Placebo

PLACEBO COMPARATOR

One subject per cohort will receive 10, 20, or 40 mg Placebo respectively.

Drug: Placebo

Interventions

PXL01 DRUG

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.

PXL01

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male healthy volunteers
• Age ≥ 18 to ≤ 50 years
• BMI ≥ 18.5 to ≤ 30.0 kg/m2
• Signed written informed consent
• Ability to co-operate

You may not qualify if:

• 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

Sponsors & Collaborators

• PharmaSurgics AB: lead

Study Sites (1)

Berzelius Clinical Research Center

Linköping, SE-582 25, Sweden

Location

Study Officials

• Fredrik Huss, PhD

  Berzelius Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 23, 2010

Record last verified: 2010-04

Locations

SE (1)