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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01627002
• Other study ID #: PA401/01
• Secondary ID: 2012-001189-14
• Status: Terminated
• Phase: Phase 1
• First received: June 12, 2012
• Last updated: July 18, 2013
• Start date: May 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: ProtAffin Biotechnologie AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy adult males aged 18 to 65 years

Exclusion Criteria:

• Subjects with a clinically relevant medical history

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Quintiles	London

Sponsors (1)

Lead Sponsor	Collaborator
ProtAffin Biotechnologie AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Emergent Adverse Events		up to 14 days post dose	No
Primary	Immunogenicity	Anti-drug antibody data	Up to 28 days post dose	No
Primary	Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils	Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils	5.5 hours post dose	No
Secondary	Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)		Up to 12 time-points up to 48 hours post dose	No
Secondary	Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)		Up to 12 time-points up to 48 hours post dose	No
Secondary	Pharmacokinetic Parameters: Terminal Half-life (t1/2)		Up to 12 time-points up to 48 hours post dose	No
Secondary	Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity		Up to 12 time-points up to 48 hours post dose	No
Secondary	Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils	Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils	5.5 hours post dose	No