Post-surgery Adhesion FormationPhase 1NCT00860080
Safety Study Investigating Local Tolerability and Pharmacokinetics of PXL01 in Healthy Volunteers
A Phase 1 study testing PXL01 in people with Post-surgery Adhesion Formation, run by PharmaSurgics AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post-surgery Adhesion Formation
- What is being tested?
- PXL01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2009to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male healthy volunteers
- Age ≥ 18 to ≤ 50 years
- BMI ≥ 18.5 to ≤ 30.0 kg/m2
- Signed written informed consent
- Ability to co-operate
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
The primary objective is to investigate the local tolerability and safety of PXL01 in the doses 10, 20, 40 mg, and placebo. The secondary objective is to investigate the pharmacokinetic properties of PXL01 in single doses of 10, 20, and 40 mg.
This is a single-blind, placebo-controlled, single dose administration study in male healthy volunteers. Each Subject will visit the centre three times; one screening visit, one dose administration visit and one follow-up visit over a period of approximately 3 weeks.
At Visit 1 (screening visit), the Subject will be given verbal and written patient information and the informed consent will be signed. Thereafter, the Subject will be assessed for eligibility. Demography, concomitant medication, and medical history will be documented. A physical examination will be performed and blood/urine will be collected for safety analysis. Tests for HIV, Hepatitis B and C, drug screening and alcohol breath test will be performed. Vital signs and a 12-lead ECG will be recorded.
At Visit 2 (dose administration visit), which will occur 7±3 days after the screening visit, the Subjects will first perform an alcohol breath test and PXL01/placebo will then be administered as an abdominal subcutaneous injection. Blood samples for pharmacokinetic analysis will be drawn, pulse and blood pressure will be recorded, and local tolerability assessments will be performed prior to and 15min, 30min, 45min, 60min, 1h 15min, 1h 30min, 2h, 4h, 8h and 24h after the injection. A 12-lead ECG and body temperature will be recorded prior to dose, 1h, 2h, 4h, 8h and 24h after the injection. Blood will be collected prior to and 24 hours after the injection. Adverse Events (AEs) will be recorded and telemetry heart rythm will be monitored continuously. The Subjects will stay at the clinic for about 26 hours after the injection.
Visit 3 (Follow-up visit) will be performed 5-8 days after Visit 2. A physical examination and local tolerability assessments will be performed. Vital signs, a 12-lead ECG and AEs will be recorded. Blood/urine will be collected for safety analysis.
Each group will start by dosing two Subjects. One Subject will receive placebo and the other active treatment. If there are no safety/tolerability concerns within 48 hours, another three Subjects will receive the dose.
Prior to dose escalation, a safety monitoring board will discuss all safety data. In case of any safety/tolerability concerns, dosing may be discontinued.
- Conditions
- Post-surgery Adhesion Formation
- Being tested
- PXL01, Placebo
- Keywords
- post-surgery adhesion formation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXL01Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| PXL01 | Experimental | Four Subjects per cohort will receive 10, 20, or 40 mg PXL01 respectively. Receives: Drug: PXL01 |
| Placebo | Placebo comparator | One subject per cohort will receive 10, 20, or 40 mg Placebo respectively. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (the frequency and severity of adverse events, vital signs, haematology, clinical chemistry, urinalysis, electrocardiogram) and local tolerability (inspection of the injection site)
Measured: From dosing until 2 weeks after dosing
Secondary outcomes (1)
The pharmacokinetic parameters Cmax, tmax, AUC, and t1/2
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-surgery Adhesion FormationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaSurgics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Fredrik Huss, PhD, Principal investigator, Berzelius Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860080
- Sponsor's protocol ID
- PHSU01
- Other IDs
- EudraCT number: 2008-007506-11
- Status last verified
- Apr 2010
- First submitted
- 10 Mar 2009
- Last updated
- 23 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00860080
- Acronym / sponsor ID
- PHSU01
- Conditions
- Post-surgery Adhesion Formation
- Keywords
- post-surgery adhesion formation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PharmaSurgics ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to investigate the local tolerability and safety of PXL01 in the doses 10, 20, 40 mg, and placebo. The secondary objective is to investigate the pharmacokinetic properties of PXL01 in single doses of 10, 20, and 40 mg.
This is a single-blind, placebo-controlled, single dose administration study in male healthy volunteers. Each Subject will visit the centre three times; one screening visit, one dose administration visit and one follow-up visit over a period of approximately 3 weeks.
At Visit 1 (screening visit), the Subject will be given verbal and written patient information and the informed consent will be signed. Thereafter, the Subject will be assessed for eligibility. Demography, concomitant medication, and medical history will be documented. A physical examination will be performed and blood/urine will be collected for safety analysis. Tests for HIV, Hepatitis B and C, drug screening and alcohol breath test will be performed. Vital signs and a 12-lead ECG will be recorded.
At Visit 2 (dose administration visit), which will occur 7±3 days after the screening visit, the Subjects will first perform an alcohol breath test and PXL01/placebo will then be administered as an abdominal subcutaneous injection. Blood samples for pharmacokinetic analysis will be drawn, pulse and blood pressure will be recorded, and local tolerability assessments will be performed prior to and 15min, 30min, 45min, 60min, 1h 15min, 1h 30min, 2h, 4h, 8h and 24h after the injection. A 12-lead ECG and body temperature will be recorded prior to dose, 1h, 2h, 4h, 8h and 24h after the injection. Blood will be collected prior to and 24 hours after the injection. Adverse Events (AEs) will be recorded and telemetry heart rythm will be monitored continuously. The Subjects will stay at the clinic for about 26 hours after the injection.
Visit 3 (Follow-up visit) will be performed 5-8 days after Visit 2. A physical examination and local tolerability assessments will be performed. Vital signs, a 12-lead ECG and AEs will be recorded. Blood/urine will be collected for safety analysis.
Each group will start by dosing two Subjects. One Subject will receive placebo and the other active treatment. If there are no safety/tolerability concerns within 48 hours, another three Subjects will receive the dose.
Prior to dose escalation, a safety monitoring board will discuss all safety data. In case of any safety/tolerability concerns, dosing may be discontinued.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PXL01 | Experimental | Drug: PXL01Four Subjects per cohort will receive 10, 20, or 40 mg PXL01 respectively. |
| Placebo | Placebo comparator | Drug: PlaceboOne subject per cohort will receive 10, 20, or 40 mg Placebo respectively. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male healthy volunteers
- Age ≥ 18 to ≤ 50 years
- BMI ≥ 18.5 to ≤ 30.0 kg/m2
- Signed written informed consent
- Ability to co-operate
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PXL01PXL01 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 | PXL01 |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
Safety (the frequency and severity of adverse events, vital signs, haematology, clinical chemistry, urinalysis, electrocardiogram) and local tolerability (inspection of the injection site)
Time frame: From dosing until 2 weeks after dosing
1 secondary outcome
The pharmacokinetic parameters Cmax, tmax, AUC, and t1/2
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik Huss, PhD principal investigator
Berzelius Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PXL01 in people with Post-surgery Adhesion Formation, run by PharmaSurgics AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (the frequency and severity of adverse events, vital signs, haematology, clinical chemistry, urinalysis, electrocardiogram) and local tolerability (inspection of the injection site) (time frame: From dosing until 2 weeks after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2010.