Clinical study to investigate safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple doses of the human GATA-3-specific DNAzyme solution SB010 in patients with mild allergic asthma

• Conditions: The trial will be conducted in 38 male patients with mild allergic asthma and documented or known biphasic reaction to allergen challenge (AC).; MedDRA version: 15.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-003570-77-DE
• Lead Sponsor: sterna biologicals GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-13
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Adult male Caucasian patients aged = 18 and = 60 years,
2.Clinical diagnosis of mild asthma (according to GINA guidelines 2008 update) for at least 6 months prior to screening. No concomitant asthma treatment, except inhaled short-acting bronchodilators,
3.Screening FEV1 value of FEV1 = 70 % of the predicted normal value (ECSC) after a wash out of at least 6 hours for inhaled short-acting bronchodilators,
4.Patient must demonstrate sufficient induced sputum production,
5.Positive skin prick test (skin reactivity) to common aeroallergens (e.g. animal epithelia, dust mite),
6.Patient must demonstrate positive allergen-induced early- and late-phase airway bronchoconstriction,
7.At all timepoints before AC and MCh, patients must show FEV1 not below 65 % predicted,
8.Presence of sputum eosinophils either before or after screening allergen challenge (first or second induced sputum),
9.Patient has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he may be exposed, and has given written consent to participation in the trial prior to trial start and any trial-related procedure,
10.Patient is able to understand and give written informed consent and has signed a written informed consent form approved by the Investigator’s Research Ethics Board,
11.Non-smokers or ex-smokers who had stopped smoking for at least 1 year prior to start of the clinical study with < 10 pack years,
12.Ability to inhale in an appropriate manner (patients will be trained to inhale from the AKITA2 APIXNEB® device with a placebo medication at the screening visit),
13.Only men who do not want to father children for six months after the last dose of SB010 will be included into this study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Presence of clinically significant diseases other than asthma (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc.), which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient’s ability to take part in it,
2.Presence of relevant pulmonary diseases or history of thoracic surgery, such as:
-known active tuberculosis,
-History of interstitial lung or pulmonary thromboembolic disease,
-Pulmonary resection during the past 12 months,
-History of status asthmaticus,
-History of bronchiectasis secondary to respiratory diseases (e.g. cystic fibrosis, Kartagener’s syndrome, etc.),
-History of chronic bronchitis, emphysema, allergic bronchopulmonary aspergillosis or respiratory infection within the 4 preceding weeks of the first morning IMP administration,
3.Patients on concomitant treatments, except for inhaled short-acting bronchodilators as judged by the investigator,
4.Use of short-acting ß2-agonists 6 hours before study visits 2, 3, 4, 5, 11, and 12,
5.Hospitalisation or emergency room treatment for acute asthma in the 6 months prior to screening, between screening and the start of the treatment period,
6.Intubation (ever) or hospitalisation for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 months of the screening visit,
7.History or current evidence of clinically relevant allergies or idiosyncrasy to drugs,
8.History of allergic reactions to any active or inactive ingredients of the nebuliser solution,
9.ECG abnormalities of clinical relevance,
10.Subjects with a resting heart rate < 45 bpm, systolic blood pressure < 100 mmHg, diastolic blood pressure < 60 mmHg,
11.Proneness to orthostatic dysregulation, faintings, or blackouts,
12.History of malignancy within the past 5 years, except excised basaliomas,
13.Clinically relevant abnormalities in clinical chemical, haematological or in any other laboratory variables as judged by the investigator,
14.Clinically relevant acute infections in the last 4 weeks preceeding AC,
15.Clinically relevant chronic infections,
16.Positive results in any of the virology tests of acute or chronic infectious human immunodeficiency virus (HIV) and hepatitis B/C virus infections,
17.Positive drug screen,
18.Abuse of alcohol or drugs,
19.Positive cotinine test,
20.Treatment with any known enzyme inducing or inhibiting agents (St. John's Wort (Johanniskraut), barbiturates, phenothiazines, cimetidine, ketoconazole etc.) within 30 days before first administration of trial medication or during treatment period of the trial,
21.Use of any prohibited concomitant medication within 2 weeks (for biologics: 6 months or 10 times the elimination half-life of the respective drug) before first trial medication administration or within < 10 times the elimination half-life of the respective drug, or the duration of the pharmacodynamic effect, whatever is longer, or anticipated concomitant medication during the treatment period,
22.Consumption of any enzyme inducing or inhibiting aliments and beverages (e.g. broccoli, Brussels sprout, grapefruit, grapefruit juice, star fruit etc.) within 14 days prior to the first trial medication administration and during the treatment period of the trial,
23.Consumption of any caffeine-containing product 6 ho

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified