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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627002
First Posted: June 25, 2012
Last Update Posted: September 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ProtAffin Biotechnologie AG
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
  • 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 Outcome Measures:
  • Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to 12 time-points up to 48 hours post dose ]
  • 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 ]
  • Pharmacokinetic Parameters: Terminal Half-life (t1/2) [ Time Frame: Up to 12 time-points up to 48 hours post dose ]
  • 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 ]
  • Assessment of the Effect of PA401 on Induced Sputum Percentage 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


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627002


Locations
United Kingdom
Quintiles
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
ProtAffin Biotechnologie AG
Investigators
Principal Investigator: Jim Ritter, MD Quintiles, Inc.
  More Information

Responsible Party: ProtAffin Biotechnologie AG
ClinicalTrials.gov Identifier: NCT01627002     History of Changes
Other Study ID Numbers: PA401/01
2012-001189-14 ( EudraCT Number )
First Submitted: June 12, 2012
First Posted: June 25, 2012
Results First Submitted: July 18, 2013
Results First Posted: September 23, 2013
Last Update Posted: September 23, 2013
Last Verified: July 2013

Keywords provided by ProtAffin Biotechnologie AG:
Phase 1
First in Human
Healthy Volunteers
Lipopolysaccharide Challenge