STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Sponsor: Biogen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01371305
• Collaborator: (none)
• Enrollment: 41
• Locations: 10
• Arms: 2
• Actual Duration (Months): 56.5
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as STX-100) in participants with IPF. The Secondary objectives are to estimate the pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple, escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of BG00011 in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis (IPF)	Drug: BG00011; Drug: Placebo	Phase 2

Detailed Description

This study was previously posted by Stromedix, Inc. In April, 2014, sponsorship of the trial was transferred to Biogen. The study drug name was changed from STX-100 to BG00011 and the study number was changed from STX-003 to 203PF201, to align with sponsor conventions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Escalation Study of STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
• Actual Study Start Date: Jul 16, 2012
• Actual Primary Completion Date: Mar 31, 2017
• Actual Study Completion Date: Mar 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BG00011 Participants will receive 8 consecutive weekly doses of BG00011	Drug: BG00011; BG00011 will be administered at varying doses via subcutaneous (SC) injection; Other Names: STX-100
Placebo Comparator: Placebo Participants will receive 8 consecutive weekly doses of placebo.	Drug: Placebo; Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AEs) [up to Week 19]

   An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

1. Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011 [Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50]

2. Maximum Observed Serum Concentration (Cmax) of BG00011 [Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50]

3. Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011 [Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50]

4. Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011 [Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50]

5. Apparent Terminal Elimination Half Life (T1/2) of BG00011 [Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50]

6. Apparent Terminal Rate Constant [λz] [Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50]

7. Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011 [Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50]

8. Apparent Clearance (CL/F) of BG00011 [Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50]

9. Apparent Volume of Distribution (Vd/F) of BG00011 [Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50]

10. Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL) [Baseline, Day 8 (Follow up)]

    The expression level of 7 genes; Arachidonate 5-lipoxygenase (ALOX5), fibronectin 1 (FN1), Oxidized low density lipoprotein receptor 1 (OLR1), Plasminogen activator inhibitor-1 (PAI-1; aka SERPINE 1), Transglutaminase 2 (TGM2), Triggering receptor expressed on myeloid cells 1 (TREM1), and v-ets erythroblastosis virus E26 oncogene homolog 1 (ETS1) were assessed via BAL as well as a ratio of pSMAD2 to tSMAD2 levels.

11. Number of Participants With Treatment Emergent Antibodies to BG00011 [Up to Week 19]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 84 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

1. Clinical features consistent with IPF prior to screening (based on the American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) consensus criteria for the diagnosis of IPF).

2. Forced (expiratory) Vital Capacity (FVC) ≥ 50% of predicted value.

3. DLco (corrected for hemoglobin) ≥ 30% predicted value.

4. Oxygen saturation > 90% at rest by pulse oximetry while breathing ambient air or receiving ≤2 L/minute of supplemental oxygen.

5. Residual volume ≤ 120% predicted value.

6. Ratio of Forced Expiratory Volume over 1 second (FEV1) to FVC ≥ 0.65 after the use of a bronchodilator.

7. Other known causes of interstitial lung disease have been excluded (e.g., drug toxicities, environmental exposures, connective tissue diseases).

8. High Resolution Computed Tomography (HRCT) image fulfills the criteria for 'Usual Interstitial Pneumonia (UIP) pattern'.

9. If the HRCT image does not fulfill the criteria for 'UIP pattern' a surgical lung biopsy is necessary for the diagnosis of IPF (lung biopsy performed prior to screening is acceptable). If a lung biopsy has been performed, it must fulfill the histopathological criteria for either 'UIP pattern' or 'probable UIP pattern' with the appropriate HRCT correlate.

10. Adequate bone marrow and liver function.

11. Patient has a life expectancy of at least 12 months.

Key Exclusion Criteria:

1. Findings that are diagnostic of a condition other than UIP on surgical lung biopsy (performed either before or after screening), HRCT imaging, transbronchial lung biopsy, or bronchoalveolar lavage (BAL).

2. Serious local infection or systemic infection within 3 months prior to screening.

3. Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 4 weeks of initial screening.

4. Currently receiving high dose corticosteroid, cytotoxic therapy (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), nintedanib (Ofev®), vasodilator therapy for pulmonary hypertension (e.g., bosentan), unapproved and/or investigational therapy for IPF or administration of such therapeutics within 5 half-lives of the agent prior to initial screening in this study.

5. End-stage fibrotic disease requiring organ transplantation within 6 months

NOTE: Other protocol defined Inclusion/Exclusion Criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	San Francisco	California	United States	94143
2	Research Site	Atlanta	Georgia	United States	30322
3	Research Site	Kansas City	Kansas	United States	66160
4	Research Site	Boston	Massachusetts	United States	02114
5	Research Site	Boston	Massachusetts	United States	02115
6	Research Site	Lebanon	New Hampshire	United States	03756
7	Research Site	Cleveland	Ohio	United States	44195
8	Research Site	Pittsburgh	Pennsylvania	United States	15213
9	Research Site	Nashville	Tennessee	United States	37232
10	Research Site	Houston	Texas	United States	77030

Sponsors and Collaborators

• Biogen

Investigators

• Study Director: Medical Director, Biogen

Study Documents (Full-Text)

• Statistical Analysis Plan - May 23, 2016
• Study Protocol - Jul 16, 2015

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT01371305
• Other Study ID Numbers: 203PF201; STX-003
• First Posted: Jun 10, 2011
• Last Update Posted: Feb 28, 2020
• Last Verified: Feb 1, 2020

• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis

Study Results

Participant Flow

Recruitment Details	The participants were enrolled across 10 sites in the US.
Pre-assignment Detail	Forty-one participants were randomized and received at least one dose in the study.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg	Matching Placebo
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
Period Title: Overall Study
STARTED	6	6	6	7	6	10
COMPLETED	6	6	6	5	2	8
NOT COMPLETED	0	0	0	2	4	2

Baseline Characteristics

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg	Matching Placebo	Total
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.	Total of all reporting groups
Overall Participants	6	6	6	7	6	10	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68 (2.7)	68 (5.9)	65 (9.6)	70 (4.0)	72 (9.7)	72 (7.4)	69 (7.1)
Sex: Female, Male (Count of Participants)
Female	2 33.3%	0 0%	1 16.7%	0 0%	2 33.3%	1 10%	6 14.6%
Male	4 66.7%	6 100%	5 83.3%	7 100%	4 66.7%	9 90%	35 85.4%
Race/Ethnicity, Customized (Count of Participants)
White	6 100%	6 100%	6 100%	7 100%	6 100%	10 100%	41 100%
Not Hispanic or Latino	6 100%	6 100%	6 100%	7 100%	6 100%	10 100%	41 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.
Time Frame	up to Week 19

Outcome Measure Data

Analysis Population Description

The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg	Matching Placebo
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
Measure Participants	6	6	6	7	6	10
Number [Participants]	6 100%	5 83.3%	6 100%	4 57.1%	6 100%	7 70%

2. Secondary Outcome

Title	Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011
Time Frame	Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population = Safety population.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Measure Participants	6	6	6	7	6
Day 1	168 (NA)	101 (42.9)	132 (39.4)	134 (60.5)	96.4 (53.5)
Day 50	42.7 (61.9)	64.0 (24.8)	64.0 (51.8)	32.0 (19.6)	38.0 (39.4)

3. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) of BG00011
Time Frame	Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50

Outcome Measure Data

Analysis Population Description

PK population = Safety population.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Measure Participants	6	6	6	7	6
Day 1	71.3 (NA)	335 (178)	716 (281)	4370 (1350)	12900 (3130)
Day 50	134 (44.6)	1080 (676)	3170 (1380)	15400 (5180)	52800 (17600)

4. Secondary Outcome

Title	Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011
Time Frame	Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50

Outcome Measure Data

Analysis Population Description

PK population = Safety population.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Measure Participants	6	6	6	7	6
Day 1	9200 (NA)	44800 (24800)	92600 (40500)	513000 (264000)	1730000 (525000)
Day 50	44600 (39400)	344000 (169000)	1080000 (554000)	6370000 (3980000)	25700000 (17700000)

5. Secondary Outcome

Title	Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011
Time Frame	Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50

Outcome Measure Data

Analysis Population Description

PK population = Safety population.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Measure Participants	6	6	6	7	6
Day 1	9200 (NA)	44800 (24800)	92600 (40500)	497000 (242000)	1690000 (438000)
Day 50	21000 (8250)	159000 (91200)	465000 (209000)	2290000 (769000)	8310000 (2840000)

6. Secondary Outcome

Title	Apparent Terminal Elimination Half Life (T1/2) of BG00011
Time Frame	Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50

Outcome Measure Data

Analysis Population Description

PK population = Safety population. Data for this outcome measure was not collected at Day 1.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Measure Participants	6	6	6	7	6
Day 50	178 (NA)	177 (123)	168 (56.8)	178 (60.9)	250 (NA)

7. Secondary Outcome

Title	Apparent Terminal Rate Constant [λz]
Time Frame	Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50

Outcome Measure Data

Analysis Population Description

PK population = Safety population. Data for this outcome measure was not collected at Day 1.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Measure Participants	6	6	6	7	6
Day 50	0.00390 (NA)	0.00508 (0.00226)	0.00442 (0.00112)	0.00423 (0.00123)	0.00286 (NA)

8. Secondary Outcome

Title	Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011
Time Frame	Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50

Outcome Measure Data

Analysis Population Description

PK population = Safety population. Data for this outcome measure was not collected at Day 1.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Measure Participants	6	6	6	7	6
Day 50	41900 (NA)	362000 (173000)	1190000 (690000)	7250000 (4230000)	24300000 (NA)

9. Secondary Outcome

Title	Apparent Clearance (CL/F) of BG00011
Time Frame	Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50

Outcome Measure Data

Analysis Population Description

PK population = Safety population. Data for this outcome measure was not collected at Day 1.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Measure Participants	6	6	6	7	6
Day 50	0.913 (NA)	0.758 (0.290)	0.801 (0.441)	0.501 (0.172)	0.486 (NA)

10. Secondary Outcome

Title	Apparent Volume of Distribution (Vd/F) of BG00011
Time Frame	Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50

Outcome Measure Data

Analysis Population Description

PK population = safety population. Data for this outcome measure was not analysed on day 1.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.
Measure Participants	6	6	6	7	6
Day 50	234 (NA)	183 (96.0)	183 (88.0)	120 (29.8)	168 (NA)

11. Secondary Outcome

Title	Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)
Description	The expression level of 7 genes; Arachidonate 5-lipoxygenase (ALOX5), fibronectin 1 (FN1), Oxidized low density lipoprotein receptor 1 (OLR1), Plasminogen activator inhibitor-1 (PAI-1; aka SERPINE 1), Transglutaminase 2 (TGM2), Triggering receptor expressed on myeloid cells 1 (TREM1), and v-ets erythroblastosis virus E26 oncogene homolog 1 (ETS1) were assessed via BAL as well as a ratio of pSMAD2 to tSMAD2 levels.
Time Frame	Baseline, Day 8 (Follow up)

Outcome Measure Data

Analysis Population Description

The "Pharmacodynamic" population consisted of all participants who received at least 1 multiple dose injection of BG00011 and have a corresponding sample collected for BAL and/or blood biomarkers.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg	Matching Placebo
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received matching placebo.
Measure Participants	6	6	6	7	4	10
ALOX5; PC at Day 8 (Follow Up)	4.39 (16.560)	-0.25 (11.154)	-5.16 (23.074)	-51.07 (22.942)	-70.90 (14.633)	-7.87 (15.793)
FN1; PC at Day 8 (Follow Up)	0.42 (20.776)	-4.83 (22.035)	-16.84 (15.424)	-65.41 (16.174)	-77.42 (17.989)	-8.27 (23.881)
OLR1; PC at Day 8 (Follow Up)	-4.79 (31.104)	-1.58 (16.207)	-15.09 (25.235)	-63.64 (18.657)	-77.97 (14.602)	-3.56 (21.215)
PAI-1; aka SERPINE 1; PC at Day 8 (Follow Up)	26.98 (55.559)	-28.27 (10.055)	7.83 (30.064)	-26.06 (38.247)	71.44 (115.042)	-1.40 (59.537)
TGM2; PC at Day 8 (Follow Up)	0.71 (31.009)	-3.06 (41.757)	-13.17 (35.547)	-53.15 (28.412)	-71.35 (17.449)	15.06 (59.874)
TREM1; PC at Day 8 (Follow Up)	-3.71 (20.135)	-2.01 (16.654)	-7.66 (21.151)	-48.33 (23.511)	-63.13 (13.700)	-12.83 (17.397)
ETS1; PC at Day 8 (Follow Up)	3.16 (53.425)	-11.52 (26.342)	-10.54 (43.866)	240.59 (245.766)	103.16 (152.301)	65.10 (146.690)
pSMAD2 to tSMAD2; PC at Day 8 (Follow Up)	23.91 (54.293)	-3.33 (29.724)	-39.82 (24.675)	-63.74 (34.674)	-76.20 (14.834)	28.59 (52.270)

12. Secondary Outcome

Title	Number of Participants With Treatment Emergent Antibodies to BG00011
Time Frame	Up to Week 19

Outcome Measure Data

Analysis Population Description

The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.

Arm/Group Title	BG00011 0.015 mg	BG00011 0.1 mg	BG00011 0.3 mg	BG00011 1.0 mg	BG00011 3.0 mg	Matching Placebo
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.	Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
Measure Participants	6	6	6	7	6	10
Number [participants]	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Up to Week 19
Adverse Event Reporting Description	The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo. The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
Arm/Group Title	BG00011 0.015 mg		BG00011 0.1 mg		BG00011 0.3 mg		BG00011 1.0 mg		BG00011 3.0 mg		Matching Placebo
Arm/Group Description	Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses.		Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses.		Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses.		Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses.		Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses.		Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses.
All Cause Mortality
	BG00011 0.015 mg		BG00011 0.1 mg		BG00011 0.3 mg		BG00011 1.0 mg		BG00011 3.0 mg		Matching 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
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Serious Adverse Events
	BG00011 0.015 mg		BG00011 0.1 mg		BG00011 0.3 mg		BG00011 1.0 mg		BG00011 3.0 mg		Matching 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
Total	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		2/7 (28.6%)		1/6 (16.7%)		0/10 (0%)
Cardiac disorders
Atrioventricular Block Complete	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Type II Second-Degree Atrioventricular Block	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/10 (0%)	0
Injury, poisoning and procedural complications
Jaw fracture	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/10 (0%)	0
Nervous system disorders
Syncope	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/7 (14.3%)	1	0/6 (0%)	0	0/10 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/7 (0%)	0	0/6 (0%)	0	0/10 (0%)	0
Idiopathic Pulmonary Fibrosis Exacerbation	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	2/7 (28.6%)	2	0/6 (0%)	0	0/10 (0%)	0
Respiratory Failure	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/7 (0%)	0	1/6 (16.7%)	1	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	BG00011 0.015 mg		BG00011 0.1 mg		BG00011 0.3 mg		BG00011 1.0 mg		BG00011 3.0 mg		Matching 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
Total	6/6 (100%)		5/6 (83.3%)		6/6 (100%)		4/7 (57.1%)		6/6 (100%)		10/10 (100%)
Blood and lymphatic system disorders
Thrombocytopenia	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		1/10 (10%)
Anaemia	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Cardiac disorders
Angina Pectoris	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Atrioventricular Block Complete	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Atrioventricular Block Second Degree	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Bradycardia	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Endocrine disorders
Hypothyroidism	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Gastrointestinal disorders
Constipation	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Dyspepsia	1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Abdominal Pain	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Cheilitis	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Sensitivity of Teeth	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Umbilical Hernia	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
General disorders
Injection Site Pain	0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Fatigue	1/6 (16.7%)		0/6 (0%)		2/6 (33.3%)		0/7 (0%)		0/6 (0%)		1/10 (10%)
Chest Discomfort	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Chills	1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Chest Pain	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Infusion Site Bruising	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Injection Site Erythema	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Injection Site Paraesthesia	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Non-Cardiac Chest Pain	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Oedema Peripheral	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Pyrexia	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Vessel Puncture Site Pain	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Immune system disorders
Seasonal Allergy	0/6 (0%)		3/6 (50%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Infections and infestations
Viral Infection	2/6 (33.3%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Upper Respiratory Tract Infection	2/6 (33.3%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		1/6 (16.7%)		1/10 (10%)
Bronchitis	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Acute Sinusitis	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Sinusitis	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Genital Herpes	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		1/10 (10%)
Injury, poisoning and procedural complications
Contusion	0/6 (0%)		0/6 (0%)		0/6 (0%)		2/7 (28.6%)		0/6 (0%)		0/10 (0%)
Bone Contusion	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Fall	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Jaw Fracture	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Laceration	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Ligament Sprain	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Limb Injury	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Muscle Strain	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Procedural Complication	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Procedural Pain	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Sunburn	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Tooth Fracture	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Eye Contusion	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		1/10 (10%)
Investigations
Hepatic Enzyme Increased	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Blood Lactate Dehydrogenase Increased	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Blood Pressure Increased	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Electrocardiogram Qt Prolonged	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Glucose Urine Present	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Oxygen Saturation Decreased	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Protein Urine Present	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Urine Analysis Abnormal	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Urine Leukocyte Esterase Positive	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Cardiac Murmur	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		1/10 (10%)
Pulmonary Function Test Decreased	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		1/10 (10%)
Metabolism and nutrition disorders
Hyponatraemia	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Musculoskeletal Chest Pain	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		1/6 (16.7%)		0/10 (0%)
Myalgia	0/6 (0%)		0/6 (0%)		2/6 (33.3%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Back Pain	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Bursitis	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Muscle Fatigue	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Musculoskeletal Pain	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Musculoskeletal Stiffness	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Pain in Extremity	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		1/10 (10%)
Nervous system disorders
Dizziness	0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		1/7 (14.3%)		1/6 (16.7%)		1/10 (10%)
Headache	1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Syncope	0/6 (0%)		0/6 (0%)		0/6 (0%)		2/7 (28.6%)		0/6 (0%)		0/10 (0%)
Migraine	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Psychiatric disorders
Insomnia	2/6 (33.3%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Anxiety	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Thinking Abnormal	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis	0/6 (0%)		0/6 (0%)		0/6 (0%)		2/7 (28.6%)		3/6 (50%)		0/10 (0%)
Cough	1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		1/7 (14.3%)		2/6 (33.3%)		1/10 (10%)
Dyspnoea	1/6 (16.7%)		2/6 (33.3%)		0/6 (0%)		1/7 (14.3%)		1/6 (16.7%)		1/10 (10%)
Hypoxia	2/6 (33.3%)		0/6 (0%)		0/6 (0%)		2/7 (28.6%)		0/6 (0%)		0/10 (0%)
Viral Upper Respiratory Tract Infection	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		2/7 (28.6%)		0/6 (0%)		0/10 (0%)
Oropharyngeal Pain	0/6 (0%)		0/6 (0%)		2/6 (33.3%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Productive Cough	0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Rhinitis Allergic	2/6 (33.3%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Rhinorrhoea	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Upper-Airway Cough Syndrome	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Haemoptysis	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Increased Bronchial Secretion	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Lung Disorder	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Nasal Discharge Discoloration	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Respiratory Failure	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		1/6 (16.7%)		0/10 (0%)
Sinus Congestion	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Sleep Apnoea Syndrome	0/6 (0%)		0/6 (0%)		0/6 (0%)		1/7 (14.3%)		0/6 (0%)		0/10 (0%)
Sputum Discolored	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Skin and subcutaneous tissue disorders
Onychoclasis	1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Rash	0/6 (0%)		2/6 (33.3%)		2/6 (33.3%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Night Sweats	1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Acne	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Skin Lesion	0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/7 (0%)		0/6 (0%)		0/10 (0%)
Vascular disorders
Phlebitis Superficial	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		1/10 (10%)
Hypotension	0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/7 (0%)		0/6 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.