Clinical Trial Publications

Pulmonary deposition of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler formulated using co-suspension delivery technology in healthy male subjects

01/10/2022

This gamma scintigraphy imaging study assessed pulmonary, extrathoracic and regional lung deposition patterns of a radiolabelled inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist triple fixed-dose combination budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF 320/14.4/10 μg), delivered by pressurised metered dose inhaler (pMDI) using innovative co-suspension delivery technology (Aerosphere™)

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Lung deposition of inhaled extra fine beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide in healthy volunteers and asthma: The STORM study

04/08/2022

An extra fine formulation triple therapy combination of beclomethasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium bromide (GB) has been developed for the maintenance treatment of asthma and chronic obstructive pulmonary disease. This study used gamma scintigraphy to evaluate the intrapulmonary and extrapulmonary in vivo deposition of BDP/FF/GB, and the intrapulmonary regional distribution of the deposited formulation.

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Phase I and scintigraphy studies to evaluate safety, tolerability, pharmacokinetics, and lung deposition of inhaled GDC-0214 in healthy volunteers

14/02/2022

Several inflammatory cytokines that promote inflammation and pathogenesis in asthma signal through the Janus kinase 1 (JAK1) pathway. This phase I, randomized, placebo-controlled trial assessed the pharmacokinetics and safety of single and multiple ascending doses up to 15 mg twice daily for 14 days of a JAK1 inhibitor, GDC-0214, in healthy volunteers (HVs; n = 66).

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KVD900, an oral on-demand treatment for hereditary angioedema: Phase 1 study results

24/01/2022

 KalVista Pharmaceuticals partnered with Simbec-Orion to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KVD900, an orally administered inhibitor of PKa in healthy adults.

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A scintigraphy study of budesonide/ glycopyrrolate/formoterol fumarate metered dose inhaler in patients with moderate-to-very severe chronic obstructive pulmonary disease.

07/10/2021

We worked in partnership with Cardiff Scintigraphics Ltd to deliver this study to demonstrate effective lung deposition of a novel triple combination pressurised metered dose inhaler (pMDI) in COPD patient population. A Phase I, Single-Dose, Gamma Scintigraphy Study to Assess the Pulmonary Deposition of Technetium-99m Radiolabelled Budesonide, Glycopyrronium and Formoterol Fumarate MDI Following a Maximal […]

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Bexmarilimab, a novel macrophage re-programmer shows promising anti-tumour activity in phase I/II trial in several last line solid tumour types

01/09/2021

Simbec-Orion worked with Faron Pharmaceuticals LTD on this three-part, first-in-human phase I/II study. It was designed to assess the safety and efficacy of Bexmarilimab in Oncology patients with advanced solid tumours. The study showed that good safety and tolerability of Bexmarilimab in this initial stage, and highlighted potential for anti-tumour activity as a monotherapy.

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