14 results
2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…
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…
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…
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…
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…
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 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…
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 IPF, in addition to the patient's standard of care. The primary objective of this study is to…
To assess the effect of BLU-5937 vs placebo on 24-hour cough frequencyin adults with RCC (including unexplained chronic cough) and Baseline24-hourcough frequency >=8 coughs/h at Week 12.To determine the safety of BLU-5937 vs placebo in adults…
The primary objective of this study is to compare the efficacy of teclistamab in combination with lenalidomide (Tec-Len) with that of lenalidomide monotherapy(Len), and the efficacy of teclistamab monotherapy (Tec) with that of lenalidomide…
Primary Objective:• To determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I)• To assess the antitumor…
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…
To characterize the safety and tolerability of single intravenous (IV) doses (Part A) and intramuscular (IM) doses (Part B) of GM-2505 in healthy volunteers.