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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
ProtAffin Biotechnologie AG
ClinicalTrials.gov Identifier:
NCT01627002
First received: June 12, 2012
Last updated: July 18, 2013
Last verified: July 2013
  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

Further study details as provided by ProtAffin Biotechnologie AG:

Primary Outcome Measures:
  • Treatment Emergent Adverse Events [ Time Frame: up to 14 days post dose ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: Up to 28 days post dose ] [ Designated as safety issue: No ]
    Anti-drug antibody data

  • Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils [ Time Frame: 5.5 hours post dose ] [ Designated as safety issue: No ]
    Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils


Secondary Outcome Measures:
  • Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to 12 time-points up to 48 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Up to 12 time-points up to 48 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetic Parameters: Terminal Half-life (t1/2) [ Time Frame: Up to 12 time-points up to 48 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity [ Time Frame: Up to 12 time-points up to 48 hours post dose ] [ Designated as safety issue: No ]
  • Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils [ Time Frame: 5.5 hours post dose ] [ Designated as safety issue: No ]
    Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils


Enrollment: 49
Study Start Date: May 2012
Study Completion Date: April 2013
Primary Completion Date: April 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
Criteria

Inclusion Criteria:

  • Healthy adult males aged 18 to 65 years

Exclusion Criteria:

  • Subjects with a clinically relevant medical history
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627002

Locations
United Kingdom
Quintiles
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
ProtAffin Biotechnologie AG
Investigators
Principal Investigator: Jim Ritter, MD Quintiles
  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
Results First Received: July 18, 2013
Last Updated: July 18, 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 April 15, 2014