Assessment of XXX using Whole Human Blood Flow Cytometry : Effects in vitro on Eotaxin-induced Eosinophil Shape Change (Chemotaxis) and CD11b Upregulation

Assessment of the effects of SYN-XXX on the secretion of PTH by primary bovine parathyroid cell cultures (monolayer and pseudogland)

Phase 1 - Volunteer studies

	1. **A single-blind, 4-way crossover study, to compare the effects of two different doses of ABT 980 (10 & 30mg) or Tamsulosin (0.4mg) with placebo on systemic blood pressure and intra urethral pressure following phenylephrine   Completed 12 normal volunteers 2. **Phase I, open-label, single-center, randomized, four-period complete crossover study to investigate the effects of single doses of RBX-2258 (1 and 2 mg), tamsulosin (0.4 mg), and placebo on phenylephrine (PE)-induced increases in prostatic pressure and blood pressure   Completed 12 normal volunteers 3. **Phase I, open-label, single-center, randomized, four-period complete crossover study to investigate the effects of single doses of RWJ 38063 PHI-013 (20 and 40 mg), tamsulosin (0.4 mg), and placebo on phenylephrine (PE)-induced increases in prostatic pressure and blood pressure   Completed 12 normal volunteers 4. **A single-blind, 3-way crossover study, to compare the effects of terazosin (5mg) or indoramin (2mg) with placebo on systemic blood pressure and intra urethral pressure following phenylephrine infusions   Completed 16 normal volunteers 5. **Phase I, single blind, placebo controlled, escalating single dose, 4-way crossover study to investigate the safety, toleration and pharmacokinetics of intravenous UK-224, 671   Completed 16 normal volunteers 6. **Phase I, single blind, placebo controlled, escalating single dose, 4-way crossover study to investigate the safety, toleration and pharmacokinetics of intravenous UK-224, 671   Completed 16 normal volunteers 7. **A pilot methodology study to determine the ejaculatory latency time in normal healthy subjects using the PE diagnostic device and video sexual stimulation   Completed 16 normal volunteers 8. **Phase I, double blind, placebo controlled, randomised four-way cross over study to investigate the safety, tolerability and pharmacokinetics of Physostigmine oral spray in healthy male volunteers   Completed 16 normal volunteers 9. **A double-blind, double dummy, randomised, three way cross-over study to investigate the pharmacokinetics and pharmacodynamics of single oral doses of RWJ-387273, sildenafil or placebo in healthy male volunteers   Completed 16 normal volunteers 10. **A clinical study in healthy normal volunteers to validate the methodologies of Laser Doppler Flowmetry (LDF) and transabdominal Doppler for the measurement of colorectal mucosal perfusion and small intestinal blood flow   Completed 24 normal female volunteers 11. A pilot study to determine the effect of tegaserod on mucosal blood flow determined by laser Doppler Flowmetry in patients with idiopathic slow transit constipation   Completed 8 female patients 12. Study in Healthy Volunteers to Investigate the Effect of Oral Dosing with AZD8309 on Airway Inflammation as Assessed in Induced Sputum after Challenge with Inhaled Lipopolysaccharide (LPS)   Completed 20 healthy participants 13. **Phase I, double blind, placebo controlled, randomised, four way cross over, single ascending dose study to investigate the safety, tolerability and pharmacokinetics of VR776 administered via Aspirair inhaler in healthy male volunteers.   Completed 13 healthy participants

	14. **A double-blind, 2-way crossover pilot study, to compare the effects of topical phenylephrine gel with placebo on systemic blood pressure and intra-urethral pressure in patients with stress incontinence   Completed n=12 patients with stress incontinence 15. **An Open-label Study of Prostate Size and Appearance in Benign Prostatic Hyperplasia Patients Treated with Terazosin   Completed n=12 patients with BPH 16. **A randomized double-blind, double dummy, placebo-controlled, three way Cross-Over Study To Compare the Effect of a single Oral dose of R216073 or Placebo with single oral dose of Oxybutynin on Unstable Detrusor Contractions Induced By Volume Provocation In Patients With Detrusor Hyper-Reflexia Secondary To Spinal Injury.   Completed n=8 pts with spinal injury 17. **A double blind, cross-over study to compare the effect of intravenous darifenacin with placebo on unstable contractions induced by provocation in patients with detrusor hyperreflexia secondary to spinal injury.   Completed n=8 pts with spinal injury 18. An Exploratory Study to Evaluate the Single-dose Pharmacokinetics and Hemoglobin Response After Multiple doses of Darbepoetin Alfa in Subjects with Chronic Obstructive Pulmonary Disease (COPD) and Anemia   Completed n=8 patients with COPD 19. A placebo-controlled, double-blind, two-way crossover study of the effects of 14 days of inhalation treatment with AVE0309 on allergen induced bronchoconstriction in male and female patients with atopic asthma   Completed n=24 patients with asthma 20. A Double Blind Randomized Five-Way Crossover, Placebo-Controlled Study to Assess the Efficacy of Three Doses (250 mg-500 mg and 1000mg bid) at steady state, of CDP323 on Eosinophils Trafficking after a Nasal Allergen Challenge in Seasonal Allergic Patients   Completed n=16 patients with allergic rhinitis 21. A multi-centre, randomised, double-blind, placebo controlled, crossover study to examine the efficacy, safety, tolerability and systemic pharmacokinetics profile of single inhaled dose of GW597901X in asthmatic subjects   Completed n=16 patients with mild asthma 22. A Double-blind, Placebo-controlled, Randomised Two-way Cross-over Study to Evaluate the Effects of KW-4490 on Early and Late Asthmatic Reactions (EAR and LAR), Airway Methacholine Reactivity, and Breath and Sputum Inflammatory Indices following Inhaled Allergen Challenge in Subjects with Mild Allergic Asthma   Completed n=24 patients with mild asthma 23. A double blind placebo controlled two way cross –over study to determine the effects of a single dose of topical steroid on eosinophils and levels of chemokines and cytokines in nasal lavage fluid following nasal allergen challenge in patients with allergic rhinitis   Completed n=16 patients with allergic rhinitis 24. A double blind placebo controlled four- way cross-over study to determine the effects of two doses of RWJ-58643 on nasal symptoms, eosinophil influx and cytokine and chemokine release following nasal allergen challenge.   Completed n=16 patients with allergic rhinitis 25. A randomized, double-blind, placebo-controlled, parallel group pilot study to determine the effect of Remicadeâ on safety, efficacy and biomarkers of inflammation in patients with asthma receiving inhaled corticosteriods: a pilot study to investigate the effect of tnf a-directed therapy in asthma   Completed 50 patients with mild to moderate asthma 26. Randomized, double blind, two centers, placebo controlled, 4-way cross-over exercise-induced bronchoconstriction trial after multiple oral dose (62.5 mg, 125 mg and 312.5 mg expressed as base) of UCB-35440-3 in male subjects with mild asthma with a known exercise-induced bronchoconstriction (EIB).   Completed 24 patients with mild asthma 27. A study to determine the value of Multi-Slice Computed Tomography for the non-invasive detection of coronary artery calcification in asymptomatic individuals and patients with mild symptoms of coronary artery disease   Completed 50 patients with coronary artery disease 28. A Randomised, Double Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Effect of Regadenoson on Pulmonary Function in AMP-Sensitive Subjects with Mild or Moderate Asthma   Completed 24 Mild Asthmatics & 24 Moderate Asthmatics 29. A Randomised, Double-Blind, Placebo-Controlled, Two-Way Crossover A Randomised, Single-Blind, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses Of CVT-6883 in Adults with Mild and Moderate Asthma   Completed 18 Mild Asthmatics 30. A double-blind, placebo-controlled, randomised, 4-way crossover single dose escalation and a double-blind, placebo-controlled, randomised, parallel group, 7-days repeat once daily dose study to investigate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW870086X administered via DISKHALER in healthy male subjects followed by a double-blind, placebo-controlled, 3-way crossover study to investigate the effect of 7-days repeat once daily inhaled doses of GW870086X administered via DISKHALER on airway responsiveness to AMP in mild steroid-naïve male asthmatics   Completed 20 Mild/Moderate Asthmatics 31. **Phase II double-blind, intermittent dose, placebo-controlled, randomised, 2 period crossover study to investigate the effect of inhaled doses of VR776 administered via Aspirair inhaler on time to ejaculation measured by stop watch in male patients with premature ejaculation   Completed 40 patients with Premature Ejaculation 32. **A Randomised, Placebo-Controlled, Crossover study to Measure the effect of Alosetron on Mucosal Blood Flow in Female Healthy Volunteers and Diarrhoea-Predominant IBS Subjects   Completed 22 Healthy Participants Active 22 D-IBS Participants 33. **An Open-label, escalating dose, proof of concept study to determine the effect of single dose oral PSD506 on unstable urinary bladder contractions induced by volume provocation in subjects with hyper-reflexia secondary to spinal injuries above T12   Completed 16 Participants with spinal injuries above T12 34. A randomised, double blind, single centre, crossover study to compare the effects on cortisol secretion of the combination FP/SM-HFA delivered by pressurised metered dose inhaler (pMDI) with FP-HFA pMDI and SM-CFC pMDI, given concurrently for 1 week in healthy volunteers   Completed 20 healthy volunteers 35. A single dose, double blind, double dummy, 3 period cross-over, placebo controlled clinical trial to assess the rate of onset of action of inhaled LAS 34273 200mcg compared to placebo and tiotropium 18mcg in patients with chronic obstructive pulmonary disease (COPD)   Completed 12 Participants with Severe COPD 36. An investigation to evaluate the technique of MRI as an assessment of the effect of anti-allergy drug treatment on internal nasal and sinus mucosal anatomy following intranasal allergen challenge in subjects with seasonal allergic rhinitis.   Completed 21 Patients Seasonal Allergic Rhinitis 37. A Pilot Methodology Study to Investigate Biomarker Activity in the Sputum of Healthy Volunteers Following Challenge with Inhaled Lipopolysaccharide (LPS)   Completed 20 healthy participants 38. A single-blind, two-way crossover pilot study, to validate the measurement of intra-urethral pressure using a novel solid-state catheter in normal female volunteers.   Active 12 healthy participants 39. Pilot Study in normal volunteers to validate sputum methodology as assessed in induced sputum after challenge with inhaled LPS   Completed 12 healthy participants 40. Randomised double blind placebo controlled 2 way Cross-Over Study in healthy volunteers to investigate the Effect of oral AZD9668 on airway inflammation as assessed in induced sputum after challenge with inhaled LPS   Completed 16 healthy participants 41. Dose response evaluation of CHF 1535 HFA pMDI in asthmatic patients using lung function, adenosine monophosphate bronchial challenge and fractional exhaled nitric oxide (FEno). A randomized, double blind, double dummy, placebo controlled, multiple dose, 3 way cross over design.   Completed 24 patients with asthma 42. A placebo controlled single blind phase 2 study to evaluate the safety and efficacy of KB002 a chimeric monoclonal antibody on eosinophil influx & markers of inflammation following intranasal allergen challenge in subjects with seasonal allergic rhinitis   Completed 16 patients with allergic rhinitis 43. A placebo controlled single blind phase 2 study to evaluate the safety and efficacy of KB002 a chimeric monoclonal antibody on neutrophil influx & markers of inflammation following intranasal lipopolysaccharide challenge in normal subjects   Completed 16 Healthy volunteers 44. A double-blind, placebo-controlled, parallel study to evaluate the effects of GW856553 on endothelial function/vascular compliance in subjects with dyslipidemia   Completed 20 patients with ischemic heart disease. 45. A double blind placebo controlled study to evaluate the effects of two regimens of GW856553 over a period of three months on an in vivo macrophage activity as assessed by FDG-PET CT imaging in the carotid arteries and aorta in patients with established atherosclerosis   In Progress n=200 patients with atherosclerosis 46. A randomized, multi-centre, parallel group, double blind, placebo and formoterol controlled 14 day dose ranging trial of 4 doses of indacterol delivered via Twisthaler® in adult and adolescent patients with persistent asthma   Completed n=24 patients (170 study total) with moderate asthma 47. A Pilot Methodology Study to Investigate Biomarker Activity in the Sputum of Healthy Volunteers Following Challenge with Inhaled Lipopolysaccharide (LPS)   Completed 12 normal subjects 48. A two-center, double-blind, placebo-controlled, randomized, 2-period cross-over, Phase IIa study to investigate the pharmacodynamics, tolerability and safety, and pharmacokinetics of ACT129968 in subjects with mild to moderate allergic asthma   In Progress n=20 smokers; n=20 normal subjects n=60 COPDpts 49. A 2-Center, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of 600 mg MEM 1414 in the Human Allergen Challenge Model.   In Progress n=18 mild asthma pts 50. A randomised, double-blind, placebo-controlled, 2-period cross-over study to evaluate the effect of treatment with GSK2190915 on the allergen-induced asthmatic response in subjects with mild asthma   In Progress n=16 mild asthma patients 51. A randomised, double-blind, placebo-controlled, 3-period cross-over study to evaluate the effect of 2 doses of GSK2190915 on the allergen-induced early asthmatic response in subjects with mild asthma   In Progress n= 36 mild asthmatics 52. A Randomized Clinical Trial to Study the Effects of Single Dose of Corticosteroid on Response to Nasal Allergen Challenge in Patients   In Progress n=12 healthy participants 53. **A pilot study to evaluate a novel wearable conditional neuromodulator for treating urinary incontinence in spinal cord injury Completed n=8 spinal injury patients   Completed n=8 spinal injury patients 54. A single dose randomised double blind double dummy placebo controlled three period cross-over study comparing the onset of relief from Methacholine induced broncho-constriction with fixed combination beclomethasone dipropionate 100ug plus formoterol fumarate 6ug/actuation pMDI with HFA-134a propellant (Foster) versus standard salbutamol pMDI 100ug/actuation (Ventolin) therapy in asthmatic patients   In Progress n=24 asthmatic patients 55. An exploratory, randomised, double blind, placebo controlled, 14 day, two-way crossover, inhaled allergen challenge study to evaluate the effects of XXX in subjects with mild to moderate asthma   In Progress n=24 mild asthmatics 56. A double-blind, placebo controlled, randomised, parallel group, phase IIa study to investigate the efficacy, tolerability and safety of 8 doses of AZD8848 administered intranasally once weekly over 7 weeks in mild to moderate asthma patients challenged with an inhaled allergen   In Progress n= 50 mild asthmatics 57. An exploratory, randomised, double blind, placebo-controlled, 14 day, three-way crossover study, followed by an open label 1 day period when subjects will be dosed with intranasal fluticasone, nasal allergen challenge (NAC) study to evaluate the effects of XXX on the release of inflammatory mediators after NAC with Timothy grass pollen in subjects with allergic rhinitis out of season   In Progress n=50 allergic rhinitis patients 58. **A randomised, double-blind, active-controlled, 3-way Cross-over study to evaluate the effect on trough FEV1. After 4 weeks treatment with chf 5188 pmdi (400/4µg qd) (fixed combination budesonide / carmoterol 200/2µg) in adult Patients with moderate or severe persistent asthma   In Progress n=50 asthmatic patients