A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401
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Purpose
The purpose of this study is to examine the safety, tolerability, immunogenicity and the way the body absorbs, distributes, breaks down and excretes various increasing single and multiple subcutaneous doses of PA401 in healthy subjects.
This study will also look at the effect of PA401 on inflammation in the lungs following an inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum induction (a procedure performed to help to cough up sputum (phlegm)) after a single subcutaneous dose of two dose levels.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Biological: PA401 Other: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 1, FIH, Double-blind, Randomised Placebo-controlled Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of PA401, and the Effects of PA401 Following LPS Challenge, in Healthy Subjects |
- Safety and tolerability profile [ Time Frame: up to 14 days post dose ] [ Designated as safety issue: No ]
The safety and tolerability profile will be assessed by the following:
Adverse events; blood pressure; pulse rate; respiration rate; body temperature; ECG parameters; clinical laboratory data; FEV1; urinalysis and microscopy
- Immunogenicity [ Time Frame: Up to 28 days post dose ] [ Designated as safety issue: No ]Anti-drug anti-body data
- Pharmacokinetic Parameters [ Time Frame: Up to 12 time-points up to 48 hours post dose ] [ Designated as safety issue: No ]Pharmacokinetic parameters will include Cmax, tmax, t½: terminal half-life; AUC
| Estimated Enrollment: | 66 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PA401
PA401 is a potent inhibitor of neutrophil activation and transmigration under development as a novel parenteral anti-inflammatory therapy for respiratory indications such as chronic obstructive pulmonary disease (COPD) and Cystic Fibrosis (CF). PA401 is a genetically engineered and recombinantly expressed mutant of the bioactive form of human interleukin-8.
|
Biological: PA401
Part A of Study: Subcutaneous, 0.1mg to 50mg, single ascending doses Part B of Study: Subcutaneous, up to 17.1mg, single dose
|
|
Placebo Comparator: Placebo
Placebo
|
Other: Placebo
Subcutaneous
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adult males aged 18 to 65 years
Exclusion Criteria:
- Subjects with a clinically relevant medical history
Contacts and Locations More Information
No publications provided
| Responsible Party: | ProtAffin Biotechnologie AG |
| ClinicalTrials.gov Identifier: | NCT01627002 History of Changes |
| Other Study ID Numbers: | PA401/01, 2012-001189-14 |
| Study First Received: | June 12, 2012 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by ProtAffin Biotechnologie AG:
|
Phase 1 First in Human Healthy Volunteers Lipopolysaccharide Challenge |
ClinicalTrials.gov processed this record on May 23, 2013