A Phase 1, First in Human Study to Investigate the Safety and Tolerability of PA401
Sponsor
ProtAffin Biotechnologie AG (Industry)
Overall Status
Terminated
CT.gov ID
NCT01627002
Collaborator
(none)
49
1
2
11
4.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
49 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date
:
May 1, 2012
Actual Primary Completion Date
:
Apr 1, 2013
Actual Study Completion Date
:
Apr 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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
|
| Placebo Comparator: Placebo Placebo |
Other: Placebo
Subcutaneous
|
Outcome Measures
Primary Outcome Measures
- Treatment Emergent Adverse Events [up to 14 days post dose]
- Immunogenicity [Up to 28 days post dose]
Anti-drug antibody data
- Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils [5.5 hours post dose]
Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils
Secondary Outcome Measures
- 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]
Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy adult males aged 18 to 65 years
Exclusion Criteria:
- Subjects with a clinically relevant medical history
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Quintiles | London | United Kingdom | SE1 1YR |
Sponsors and Collaborators
- ProtAffin Biotechnologie AG
Investigators
- Principal Investigator: Jim Ritter, MD, Quintiles, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
ProtAffin Biotechnologie AG
ClinicalTrials.gov Identifier:
NCT01627002
Other Study ID Numbers:
- PA401/01
- 2012-001189-14
First Posted:
Jun 25, 2012
Last Update Posted:
Sep 23, 2013
Last Verified:
Jul 1, 2013
Keywords provided by ProtAffin Biotechnologie AG
Study Results
Participant Flow
| Recruitment Details | The study was conducted from June 2012 (first subject dosed) to April 2013 (last subject visit). The study was conducted in 2 parts; Part A was a single ascending dose study, Part B was a randomised placebo-controlled study to investigate the effect of a single dose of PA401 on sputum neutrophils following inhaled lipopolysaccharide challenge |
|---|---|
| Pre-assignment Detail | In Part B, subjects were included at baseline if they had a baseline neutrophil level in induced sputum of ≤70% |
| Arm/Group Title | Part A PA401 0.1 mg | Part A PA401 0.3 mg | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part A PA401 10 mg | Part A Placebo | Part B PA401 1.0 mg | Part B PA401 3.0 mg | Part B Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | PA401 1.0 mg was administered 30 minutes after lipopolysaccharide challenge | PA401 3.0 mg was administered 30 minutes after lipopolysaccharide challenge | Placebo was administered 30 minutes after lipopolysaccharide challenge | ||||||
| Period Title: Overall Study | |||||||||
| STARTED | 4 | 4 | 4 | 4 | 2 | 9 | 10 | 5 | 7 |
| COMPLETED | 4 | 4 | 4 | 4 | 2 | 9 | 10 | 5 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Part A | Part B | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Overall Participants | 27 | 22 | 49 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
27
100%
|
22
100%
|
49
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
27
100%
|
22
100%
|
49
100%
|
| Region of Enrollment (participants) [Number] | |||
| United Kingdom |
27
100%
|
22
100%
|
49
100%
|
Outcome Measures
| Title | Treatment Emergent Adverse Events |
|---|---|
| Description | |
| Time Frame | up to 14 days post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analyses were performed on all subjects who receive a dose of PA401 or placebo and who had any post-dose measurements |
| Arm/Group Title | Part A PA401 0.1 mg | Part A PA401 0.3 mg | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part A PA401 10 mg | Part A Placebo | Part B PA401 1.0 mg | Part B PA401 3.0 mg | Part B Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | |||||||||
| Measure Participants | 4 | 4 | 4 | 4 | 2 | 9 | 10 | 5 | 7 |
| Number [Participants] |
3
11.1%
|
3
13.6%
|
4
8.2%
|
2
NaN
|
2
NaN
|
3
NaN
|
7
NaN
|
5
NaN
|
4
NaN
|
| Title | Immunogenicity |
|---|---|
| Description | Anti-drug antibody data |
| Time Frame | Up to 28 days post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analyses were performed on all subjects who received a dose of PA401 or placebo and who had any post-dose assessments |
| Arm/Group Title | Part A PA401 0.1 mg | Part A PA401 0.3 mg | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part A PA401 10 mg | Part A Placebo | Part B PA401 1.0 mg | Part B PA401 3.0 mg | Part B Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | |||||||||
| Measure Participants | 4 | 4 | 4 | 4 | 2 | 9 | 10 | 5 | 7 |
| Day 1 anti-drug antibody (ADA) positive |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Day 1 ADA positive and cross-reactive with IL-8 |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Day 1 Pre-existing IL-8 autoantibodies |
1
3.7%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Day 15 ADA positive |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Day 15 ADA positive and cross-reactive with IL-8 |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Day 15 Pre-existing IL-8 autoantibodies |
1
3.7%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Day 29 ADA positive |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Day 29 ADA positive and cross-reactive with IL-8 |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Day 29 Pre-existing IL-8 autoantibodies |
1
3.7%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Title | Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax) |
|---|---|
| Description | |
| Time Frame | Up to 12 time-points up to 48 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part B PA401 1.0 mg | Part B PA401 3.0 mg |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 4 | 4 | 8 | 5 |
| Mean (Standard Deviation) [ng/mL] |
1.88
(0.587)
|
7.51
(2.64)
|
1.29
(0.411)
|
2.85
(0.805)
|
| Title | Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax) |
|---|---|
| Description | |
| Time Frame | Up to 12 time-points up to 48 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part B PA401 1.0 mg | Part B PA401 3.0 mg |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 4 | 4 | 8 | 5 |
| Mean (Standard Deviation) [hours] |
2.75
(0.87)
|
2.02
(0.40)
|
2.09
(0.53)
|
2.20
(1.10)
|
| Title | Pharmacokinetic Parameters: Terminal Half-life (t1/2) |
|---|---|
| Description | |
| Time Frame | Up to 12 time-points up to 48 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part B PA401 1.0 mg | Part B PA401 3.0 mg |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 4 | 4 | 8 | 3 |
| Mean (Standard Deviation) [hours] |
9.26
(2.57)
|
8.44
(0.846)
|
6.17
(1.79)
|
10.1
(4.47)
|
| Title | Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity |
|---|---|
| Description | |
| Time Frame | Up to 12 time-points up to 48 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part B PA401 1.0 mg | Part B PA401 3.0 mg |
|---|---|---|---|---|
| Arm/Group Description | ||||
| Measure Participants | 3 | 4 | 7 | 3 |
| Mean (Standard Deviation) [ng.h/mL] |
23.9
(9.72)
|
93.2
(12.1)
|
12.2
(3.82)
|
29.3
(5.66)
|
| Title | Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils |
|---|---|
| Description | Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils |
| Time Frame | 5.5 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Part B 3.0 mg PA401 | Part B 1.0 mg PA401 | Part B Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 5 | 10 | 7 |
| Least Squares Mean (95% Confidence Interval) [x10e6 cells/g] |
11.6882
|
7.7274
|
12.7241
|
| Title | Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils |
|---|---|
| Description | Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils |
| Time Frame | 5.5 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Part B 3.0 mg PA401 | Part B 1.0 mg PA401 | Part B Placebo |
|---|---|---|---|
| Arm/Group Description | |||
| Measure Participants | 5 | 10 | 7 |
| Least Squares Mean (95% Confidence Interval) [percentage of total cells] |
32.9429
|
36.7007
|
34.3856
|
Adverse Events
| Time Frame | Up to 14 days post dose | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were monitored by the clinical staff asking non-leading questions during the period of confinement to the clinic. | |||||||||||||||||
| Arm/Group Title | Part A PA401 0.1 mg | Part A PA401 0.3 mg | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part A PA401 10 mg | Part A Placebo | Part B PA401 1.0 mg | Part B PA401 3.0 mg | Part B Placebo | |||||||||
| Arm/Group Description | ||||||||||||||||||
All Cause Mortality |
||||||||||||||||||
| Part A PA401 0.1 mg | Part A PA401 0.3 mg | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part A PA401 10 mg | Part A Placebo | Part B PA401 1.0 mg | Part B PA401 3.0 mg | Part B Placebo | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| Part A PA401 0.1 mg | Part A PA401 0.3 mg | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part A PA401 10 mg | Part A Placebo | Part B PA401 1.0 mg | Part B PA401 3.0 mg | Part B Placebo | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) | 1/2 (50%) | 0/9 (0%) | 0/10 (0%) | 0/5 (0%) | 0/7 (0%) | |||||||||
| Cardiac disorders | ||||||||||||||||||
| Atrial Fibrillation | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| Part A PA401 0.1 mg | Part A PA401 0.3 mg | Part A PA401 1.0 mg | Part A PA401 3.0 mg | Part A PA401 10 mg | Part A Placebo | Part B PA401 1.0 mg | Part B PA401 3.0 mg | Part B Placebo | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/4 (75%) | 3/4 (75%) | 4/4 (100%) | 2/4 (50%) | 2/2 (100%) | 3/9 (33.3%) | 7/10 (70%) | 5/5 (100%) | 4/7 (57.1%) | |||||||||
| Ear and labyrinth disorders | ||||||||||||||||||
| Tinnitus | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Eye disorders | ||||||||||||||||||
| Vision Blurred | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Photophobia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 |
| Gastrointestinal disorders | ||||||||||||||||||
| Vomiting | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/2 (100%) | 12 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 |
| Nausea | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 1 | 0/9 (0%) | 0 | 2/10 (20%) | 2 | 2/5 (40%) | 2 | 1/7 (14.3%) | 1 |
| Gastrointestinal Disorder | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Abdominal Pain | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 1 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Mouth Ulceration | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 |
| Diarrhoea | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 2/5 (40%) | 2 | 1/7 (14.3%) | 1 |
| Abdominal Discomfort | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 4/5 (80%) | 4 | 1/7 (14.3%) | 1 |
| General disorders | ||||||||||||||||||
| Pyrexia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Injection Site Pruritus | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Injection Site Erythema | 0/4 (0%) | 0 | 2/4 (50%) | 2 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 2/10 (20%) | 3 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Influenza Like Illness | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 3/10 (30%) | 4 | 1/5 (20%) | 2 | 2/7 (28.6%) | 2 |
| Chills | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Chest Discomfort | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 |
| Oedema Peripheral | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 |
| Injection Site Reaction | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||
| Viral Infection | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Nasopharyngitis | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 1 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Rhinitis | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Excoriation | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Contusion | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 |
| Investigations | ||||||||||||||||||
| C-Reactive Protein Increased | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 2/2 (100%) | 2 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||
| Hypoglycaemia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Pain In Extremity | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Musculoskeletal Stiffness | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Back Pain | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||
| Headache | 2/4 (50%) | 2 | 0/4 (0%) | 0 | 2/4 (50%) | 2 | 0/4 (0%) | 0 | 2/2 (100%) | 2 | 3/9 (33.3%) | 3 | 3/10 (30%) | 3 | 3/5 (60%) | 3 | 2/7 (28.6%) | 2 |
| Dizziness | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 2/5 (40%) | 2 | 0/7 (0%) | 0 |
| Disturbance In Attention | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/2 (50%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Syncope | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 |
| Presyncope | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 2/10 (20%) | 2 | 2/5 (40%) | 2 | 0/7 (0%) | 0 |
| Paraesthesia | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 |
| Lethargy | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 3/5 (60%) | 3 | 0/7 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||||||
| Dysuria | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/5 (20%) | 1 | 0/7 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Epistaxis | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 1/4 (25%) | 1 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Throat Irritation | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Rhinorrhoea | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/5 (0%) | 0 | 0/7 (0%) | 0 |
| Oropharyngeal Pain | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 |
| Dry Throat | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 1 |
| Cough | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/4 (0%) | 0 | 0/2 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/5 (0%) | 0 | 1/7 (14.3%) | 2 |
Limitations/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
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
After completion of the study, the Investigator may prepare a joint publication with the Sponsor. The Investigator must undertake not to submit any part of the individual data from this protocol for publication without prior consent of the Sponsor at a mutually agreed time.
Results Point of Contact
| Name/Title | ProtAffin Biotechnologie AG |
|---|---|
| Organization | ProtAffin Biotechnologie AG |
| Phone | |
| office@protaffin.com |
Responsible Party:
ProtAffin Biotechnologie AG
ClinicalTrials.gov Identifier:
NCT01627002
Other Study ID Numbers:
- PA401/01
- 2012-001189-14
First Posted:
Jun 25, 2012
Last Update Posted:
Sep 23, 2013
Last Verified:
Jul 1, 2013