healthy subjects MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Biomsiamose solution 100 mg/mL
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Bimosiamose
CAS Number: 187269-40-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentr
Sponsors
REVOTAR Biopharmaceuticals AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Informed consent signed by the subject. b) Healthy male or postmenopausal female subjects (medical certificate by gynecologist) or sterile female subjects with documented hysterectomy or tubal ligation. c) Aged 18 to 65 at screening. d) Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests and electrocardiogram. e) At screening systolic blood pressure 90-150 mm Hg, diastolic blood pressure 50-90 mm Hg and pulse rate 40 - 90 min-1 (sitting after at least three minutes rest). f) At screening oral body temperature between 35.0-37.5° C g) At screening FEV1 at least 80% of predicted. h) Body weight ? 50 kg and in defined relation to height. Body mass index within 19 – 32 kg/ m2. i) Able to produce sputum with normal sputum neutrophil levels at screening (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports of a recent tobacco use and/or who has a urine cotinine = 500 ng/mL. b) Use of any prescription drugs, herbal supplements, within four weeks prior to first dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two weeks prior to first dosing. c) Treatment with an investigational drug within eight weeks prior to dosing, or within 5 half lives of the investigational drug (whichever is longer). d) Donation or loss of 400 mL or more of blood within eight weeks prior to dosing. e) Significant illness within two weeks prior to dosing (e.g., infection). f) A past medical history of clinically significant ECG abnormalities. g) Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc). h) Recent (within the last three years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated). i) Active atopic disease at time of screening and randomization into the study. History of mild seasonal allergic rhinitis is acceptable providing the allergic rhinitis is not anticipated to be active during the course of the subject’s participation in the study. j) Allergy to the investigational compound class being used in this study. k) Previous treatment with Bimosiamose l) Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject’s medical history and/or clinical or laboratory evidence of any of the following: • Any history of inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; • Any history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; • Any history of pancreatic injury or pancreatitis; • Evidence of urinary obstruction or difficulty in voiding at screening. m) Total WBC count or platelet count which fall outside the normal reference range of the laboratory at screening and is assessed as clinically significant by the investigator. n) Laboratory test results outside the reference values as laid down by the study centre, which may be an evidence of disease and/or is assessed as clinically significant by the investigator. Positive result of HIV1/2 antibodies, HCV antibody or HBs antigen testing, evidence of acute Hepatitis A infection (anti-HAV-IgM positive). o) History of immunodeficiency diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is designed to determine the effect of Bimosiamose on ozone induced sputum neutrophilia after repeated inhalative doses. ;Secondary Objective: Effect of Bimosiamose on the biomarkers matrix-metalloproteinase-9 (MMP), interleukin-8 (IL-8) and myeloperoxidase (MPO) in induced sputum under Bimosiamose and Placebo. Safety and tolerability of repeated inhalative doses of Bimosiamose will be assessed by spirometry, measurement of vital signs, ECG, clinical laboratory and observation of adverse events.;Primary end point(s): Ratio of neutrophil counts under Bimosiamose and Placebo | — |
Countries
Germany
Outcome results
None listed