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

NCT01627002 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2013-09-23

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

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

OTHER

Placebo

Subcutaneous

Sponsors & Collaborators

  • ProtAffin Biotechnologie AG

    lead INDUSTRY

Principal Investigators

  • Jim Ritter, MD · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01627002 on ClinicalTrials.gov