NCT01627002

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2012

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
6 months until next milestone

Results Posted

Study results publicly available

September 23, 2013

Completed
Last Updated

September 23, 2013

Status Verified

July 1, 2013

Enrollment Period

11 months

First QC Date

June 12, 2012

Results QC Date

July 18, 2013

Last Update Submit

July 18, 2013

Conditions

Healthy Volunteers

Keywords

Phase 1First in HumanHealthy VolunteersLipopolysaccharide Challenge

Outcome Measures

Primary Outcomes (3)

  • Treatment Emergent Adverse Events

    up to 14 days post dose

  • Immunogenicity

    Anti-drug antibody data

    Up to 28 days post dose

  • 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

Secondary Outcomes (5)

  • Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)

    Up to 12 time-points up to 48 hours post dose

  • Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)

    Up to 12 time-points up to 48 hours post dose

  • Pharmacokinetic Parameters: Terminal Half-life (t1/2)

    Up to 12 time-points up to 48 hours post dose

  • Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity

    Up to 12 time-points up to 48 hours post dose

  • Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils

    5.5 hours post dose

Study Arms (2)

PA401

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

PA401BIOLOGICAL

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

PA401
PlaceboOTHER

Subcutaneous

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult males aged 18 to 65 years

You may not qualify if:

  • Subjects with a clinically relevant medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quintiles

London, SE1 1YR, United Kingdom

Location

Limitations and Caveats

Part B of the study was terminated early which led to a small number of subjects analyzed. Pharmacokinetic parameters were not calculated for Part A 0.3mg and 10 mg PA401

Results Point of Contact

Title
ProtAffin Biotechnologie AG
Organization
ProtAffin Biotechnologie AG
office@protaffin.com

Study Officials

  • Jim Ritter, MD

    Quintiles, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 25, 2012

Study Start

May 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

September 23, 2013

Results First Posted

September 23, 2013

Record last verified: 2013-07

Locations

GB(1)