44 results
Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.
Primary Objective:To assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of…
Primary objective:To evaluate the efficacy of soraprazan in reducing the amount of lipofuscin inRPE cells of subjects with Stargardt disease by assessing the change inquantitative auto-fluorescence (qAF8) from baseline to after treatment…
Primary Objective- To evaluate the safety and tolerability of AP30663 in healthy malesSecondary Objectives- To evaluate the pharmacokinetic profile of AP30663.Exploratory Objectives- To evaluate the effect of AP30663 on electrocardiographical…
Primary Objectives:* Identify the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D, 200mg BID) of TAS-119.
The primary objective of this study is to evaluate the inhibition of PACAP-38 induced migraine-like attacks by AMG 334Secondary objectives:* To evaluate the inhibition of PACAP-38 induced headaches by AMG 334* To evaluate the safety, tolerability,…
Part 1:Primary Objective- To assess the safety and tolerability of SBT-020 in early stage HD patients. Secondary Objective- To investigate the effect of SBT-020 on mitochondrial function, measured by dynamic 31P-MRS in calf muscles of early stage HD…
The primary objective is to assess the effect a resuscitation strategy using balanced solutions versus unbalanced solutions on regional and microvascular perfusion relative to global hemodynamics in intensive care patients following elective cardiac…
The objective of this study is to investigate the mechanism(s) of action of tirzepatide in the kidney, in participants who are overweight or living with obesity and coexisting CKD, with and without T2D, to inform potential future kidney outcomes…
Primary Objective:Assess the antitumor activity of BDTX-189 as a single agent by evaluation of objective response as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with allosteric human epidermal growth…
To evaluate the effect of BIVV020 on the durabilityof platelet response in participants withpersistent/chronic immune thrombocytopenia (ITP)Secondary• To assess the safety and tolerability of BIVV020• To assess the pharmacokinetics (PK) of BIVV020•…
DOSE ESCALATION PHASE: PART A: Primary Objectives: • To assess the safety and tolerability of KBA1412 when given as monotherapy. • To determine the maximum tolerated dose (MTD) and/or Recommended Phase II dose (RP2D) of KBA1412 when given as…
pSS: • To compare the efficacy of branebrutinib with PBO at Week 24 in the treatment of subjects with pSS• To compare the safety and tolerability of branebrutinib with PBO in subjects with pSSRA: • To compare the efficacy of branebrutinib with PBO…
Main objective:1. To estimate the Overall Response Rate (ORR) and the clinical benefit rate in selected cohorts of patients with hematologic malignancies,separately for each cohort2. To evaluate the safety of the selected dose regimes in an expanded…
The aim of this study is to evaluate the efficacy, safety and tolerability of BI 1015550 9 mg BID and 18 mg BID compared to placebo in patients with PF-ILD, in addition to the patient's standard of care. The primary objective of this study is…
To characterize the safety and tolerability of ascending single oral doses (part A) and ascending repeated oral doses (part B) of GM-1020 and the effect of food on single dose GM-1020 (part C) in healthy volunteers.
Primary Objective• To assess superiority of treatment with CAM2029 compared to treatment with octreotide long-acting release (LAR) or lanreotide autogel (ATG) on progression-free survival (PFS) in patients with unresectable/metastatic and well-…
The objectives of the study are to: • Assess the efficacy of 2 dose levels of COR388 HCl in Alzheimer*s disease (AD) subjects; and• Assess the safety and tolerability of 2 dose levels of COR388 HCl in AD subjects.
Primary ObjectivesParts 1 and 2: To evaluate the safety and tolerability, describe any dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD) or highest protocol- defined doses (in the absence of exceeding the MTD) and the…
Part 1; Single ascending dose (main objective)• To investigate the safety and tolerability of single oral doses of VRG50635 in healthy adult subjectsPart 1; Single ascending dose (secondary objective)• To characterize the plasma and urine…