65 results
Main objectives Part 1• To evaluate the safety and tolerability of a single oral dose of HTL0018318, administered at one of at least three ascending dose levels (maximum of 8 ascending dose levels), in healthy younger adult male subjects.• To…
The primary objective of this study is to:* Evaluate the effect of GS-6615 on exercise capacity, as measured by Peak VO2 achieved during cardiopulmonary exercise testing (CPET), in subjects with symptomatic hypertrophiccardiomyopathy (HCM).The…
The objective of the present study is to assess the effect of HTL0009936 on cognitive performance in elderly subjects with below average cognitive function. The oral pharmacokinetics of HTL0009936 shows a significant degree of variability between…
Efficacy and safety trial with S 44819 after recent ischemic cerebral Event
• To evaluate the safety and efficacy of multiple doses of XPF-001 (400 mg bid) for relief of pain in patients with IEM.• To evaluate the efficacy of multiple doses of XPF-001 (400 mg bid) for relief of vasomotor signs in patient with IEM.• To…
Main objectiveTo determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with CHC.Secondary objectivesTo assess the pharmacokinetics (PK) of multiple dosing of miravirsen administered subcutaneously to subjects…
This is a placebo- and active-controlled dose-range-finding study which isalso designed to assess the efficacy and safety of preladenant 2, 5, 10 mg twicedaily versus placebo as an adjunct therapy to L-dopa when administered to subjectswith moderate…
The aim is to investigate whether a melting tablet that contains birch pollen allergen will decrease the hay fever symptoms and may alleviate the need for conventional allergy symptom-suppressing medication. The purpose of this specific study is…
The primary objective of the study is to evaluate the safety and tolerability of single-dose IV infusion of BIIB033 administered to healthy adult volunteers.Secondary objectives of this study are:* assess the single dose PK profile of BIIB033 *…
The primary objective of this study is to compare overall survival (OS) in patients with metastatic colorectal carcinoma (CRC) when treated with FOLFIRI in combination with placebo versus FOLFIRI in combination with ramucirumab DP.Secondary…
The primary objective of this study is to evaluate overall survival (OS) in the intent-to-treat (ITT) subject population defined by this protocol.Key secondary objectives are to evaluate OS in the epidermal growth factor receptor (EGFR) wild type…
The primary objective of this phase III study in subjects with metastatic and/or unresectable GIST who have progressed after therapy with at least imatinib and sunitinib is to compare the treatment groups in terms of Progression-Free Survival (PFS…
Parts A and BPrimary objective• To investigate the inhibition of primary CNS effects of a THC challenge by CB1 receptor antagonist compared to placebo in healthy occasional users of cannabisSecondary objective• To investigate the inhibition of…
To evaluate the effect of AZD4831 as compared to placebo on the time to first COPDCompEx event in participants with moderate to severe COPD.
Primary objective* To assess the efficacy of EP547 compared to placebo on pruritus as assessed by the Worst Itch Numeric Rating Scale (WI-NRS)Secondary* To assess the efficacy of EP547 compared to placebo on the following:* Pruritus-related quality…
Primary objective- To assess the tolerability and safety of SAR444336 after single and repeated ascending subcutaneous doses Secondary objectives- To assess the PK parameters of SAR444336 after single ascending subcutaneous doses (Part 1)- To assess…
x To assess the safety and tolerability of MK-7240/PRA023 in SSc-ILD x To compare the annual rate of change from Baseline in forced vital capacity (FVC), in mL, of MK-7240/PRA023 vs. placebo over 50 weeks For more information please refer to…
The primary objective of this study is to assess the efficacy of twice per week subcutaneous (SC) doses of pegcetacoplan 1080 mg compared toplacebo in subjects with sporadic ALS as measured by the Combined Assessment of Function and Survival (CAFS)…
To evaluate the efficacy and safety of eASCs compared to placebo for the treatment of complex fistulas in Crohn*s disease over a 24- and 104-week period.