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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- ProtAffin Biotechnologie AG
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Treatment Emergent Adverse Events
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adult males aged 18 to 65 years
Exclusion Criteria
- •Subjects with a clinically relevant medical history
Outcomes
Primary Outcomes
Treatment Emergent Adverse Events
Time Frame: up to 14 days post dose
Immunogenicity
Time Frame: Up to 28 days post dose
Anti-drug antibody data
Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils
Time Frame: 5.5 hours post dose
Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils
Secondary Outcomes
- Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity(Up to 12 time-points up to 48 hours post dose)
- Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)(Up to 12 time-points up to 48 hours post dose)
- Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)(Up to 12 time-points up to 48 hours post dose)
- Pharmacokinetic Parameters: Terminal Half-life (t1/2)(Up to 12 time-points up to 48 hours post dose)
- Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils(5.5 hours post dose)