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

NCT ID: NCT01627002

Last Updated: 2013-09-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Healthy Volunteers

Keywords

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Phase 1 First in Human Healthy Volunteers Lipopolysaccharide Challenge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PA401

Intervention Type BIOLOGICAL

Part A of Study: Subcutaneous, 0.1mg to 50mg, single ascending doses Part B of Study: Subcutaneous, up to 17.1mg, single dose

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subcutaneous

Interventions

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PA401

Part A of Study: Subcutaneous, 0.1mg to 50mg, single ascending doses Part B of Study: Subcutaneous, up to 17.1mg, single dose

Intervention Type BIOLOGICAL

Placebo

Subcutaneous

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males aged 18 to 65 years

Exclusion Criteria

* Subjects with a clinically relevant medical history
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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ProtAffin Biotechnologie AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jim Ritter, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Quintiles

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2012-001189-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PA401/01

Identifier Type: -

Identifier Source: org_study_id