A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Biological: PA401; Other: Placebo

• Registration Number: NCT01627002
• Lead Sponsor: ProtAffin Biotechnologie AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-25
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-07
• Results First Submitted: 2013-07-18
• Results First Submitted QC: 2013-07-18
• Last Update Submitted: 2013-07-18
• Results First Posted: 2013-09-23
• Last Update Posted: 2013-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 49

Inclusion Criteria

• Healthy adult males aged 18 to 65 years

Exclusion Criteria

• Subjects with a clinically relevant medical history

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PA401	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.
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events	up to 14 days post dose
Immunogenicity	Up to 28 days post dose	Anti-drug antibody data
Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils	5.5 hours post dose	Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils

Secondary Outcome Measures

Name	Time	Method
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	Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils

Trial Locations

Locations (1)

Quintiles; 🇬🇧 London, United Kingdom