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

ProtAffin Biotechnologie

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Biological: PA401

Study type: Interventional

Funder types: Industry

Identifiers

NCT01627002

PA401/01

2012-001189-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult males aged 18 to 65 years

Exclusion criteria

• Subjects with a clinically relevant medical history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups, including a placebo group

PA401

Experimental group

Description:

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.

Treatment:

Biological: PA401

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo