108 results
The aim of this study is to investigate how safe, effective, and well-tolerated multiple infusions of the experimental study treatment, emapalumab (the study medication) are in controlling this disease, as well as to check the concentrations of…
Primary Objective part A:* To evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered BIW in subjects withadvanced solid tumors* To determine the MTD and/or RP2D of single-agent M4344 administered BIW in…
Part A: healthy volunteers Primary objective- To determine safety and tolerability of a single dose of VB5-845D-800CW in healthy volunteers.Secondary objective- To determine the pharmacokinetics of VB5-845D-800CW by measuring fluorescence in blood…
To evaluate the incidence of grade * 3 neutropenia (measured at Day 7 and Day 14) and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in…
The primary study objective is to determine the safety profile and tolerability of S64315 in patients with AML and MDS and to determine the recommended phase 2 dose. Secondly, the PK profile of S64315 and potential metabolites will be determined in…
* Part A: To investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing doses of YTX-7739 in healthy subjects. * Part B: To study the effect of food on pharmacokinetics of YTX-7739 in a selection of subjects who…
Primary Objectives:* To determine the safety and tolerability of ENA-001 in healthy subjects after low and high doses of ENA-001 under hypoxic and hypercapnic conditions in conjunction with low and high doses of propofol.* To determine the…
Part 1:Primary Objective- To investigate whether repeated dose GRX-917 reduces panic symptoms elicited by an experimental 35% CO2 -induced fear challenge administered in healthy CO2-sensitive subjects. Secondary Objectives- To investigate whether…
Primary Objective:- To evaluate the safety and tolerability of ENX-101 following repeated doses in healthy volunteersSecondary Objective:- To evaluate the effects of ENX-101 on the following electrocardiogram (ECG) parameters in healthy volunteers:…
The objective of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of ALKS 6610 after single ascending oral doses in healthy adult subjects.
This Phase 1, First in Human study is designed to assess the safety and systemic exposure (pharmacokinetics (PK)) of single dose (Part A,B) and multiple dose (thrice daily) for 14 days (Part C) topical M528101 Liquid 0.3% in healthy volunteers (Part…
PrimaryPart 3 - Repeated doses in atopic dermatitis (AD) patients - PDY16891* To evaluate the safety and tolerability of SAR443726 after repeated SC doses in adult participants with moderate-to-severe ADSecondaryPart 3 - Repeated doses in AD…
• To evaluate the safety and tolerability of THB001 in cold induced chronic urticaria patients
The main objective of this Phase IIa/b study is to demonstrate the effectof zibotentan on HVPG, and that dapagliflozin can mitigate fluid retention safety concernsregarding its use in this population.
Dose Expansion:Primary Objective-*To investigate the antitumor activity of HE3-DXdSecondary Objectives-*To assess the safety and tolerability of HE3-DXd in metastatic or unresectable NSCLC subjects-*To characterize the PK of HE3-DXd, total anti-HER3…
Part 1:• To evaluate the effect of IV sevuparin on inflammatory responses following an intradermal (ID) LPS challenge.Part 2:• To evaluate the effect of IV sevuparin on safety and tolerability and inflammatory responses following an intravenous (IV…
Primary objectives:• To evaluate the effect of orvepitant once daily on cough severity, as perceived by patients, with IPF• To evaluate the safety of orvepitant once daily in patients with IPFSecondary objectives:• To evaluate the effect of…
Primary:•To compare the effect of venglustat with standard of care Fabry therapies on left ventricular mass index over 18 months in participants with Fabry disease and left ventricular hypertrophySecondary:•To evaluate the effect of venglustat on…
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)…