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

July 18, 2013 updated by: ProtAffin Biotechnologie AG

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy adult males aged 18 to 65 years

Exclusion Criteria:

  • Subjects with a clinically relevant medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Subcutaneous
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Events
Time Frame: up to 14 days post dose
up to 14 days post dose
Immunogenicity
Time Frame: Up to 28 days post dose
Anti-drug antibody data
Up to 28 days post dose
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
5.5 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to 12 time-points up to 48 hours post dose
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
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
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
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
5.5 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProtAffin Biotechnologie AG

Investigators

  • Principal Investigator: Jim Ritter, MD, Quintiles, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

September 23, 2013

Last Update Submitted That Met QC Criteria

July 18, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PA401/01
  • 2012-001189-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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