69 results
To explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LOU064 over a treatment period of 4 weeks in a cohort of subjects with atopic dermatitis.
CD is a chronic, relapsing-remitting, inflammatory disease of the GI tract. Some patients may have persistent clinically active disease. The current treatment options for patients with moderate to severe CD, refractory to standard therapies that…
Primary: To investigate if CVL-865 decreases subjective anxiety symptoms elicited by a 35% CO2 inhalation challenge.Secondary: To investigate if CVL-865 decreases subjective fear symptoms elicited by a 35% CO2 inhalation challenge. To investigate if…
Primary Objectives:The primary objective of this study is to characterize the effect of repeated oral administration of TAK-788 160 mgQD on the single oral- and IV-dose PK of midazolam.Secondary Objectives:The secondary objective of this study is to…
Primary objective: To evaluate the safety and tolerability of GSK1795091 when administered in combination with either GSK3174998, GSK3359609, orpembrolizumab.Secondary objectives: * To evaluate the antitumor activity of GSK1795091 when administered…
Part A: Determine safety and tolerability of FTX-1821 in healthy subjects. Part B and C: Determine safety and tolerability of FTX-1821 in FSHD patients.
Primary Objective: To assess the safety of rVA576 in adult subjects with mild to moderate bullous pemphigoid (BP).Secondary Objectives: To assess the efficacy of rVA576 and its effect on the quality of life in adult subjects with mild to moderate…
Primary Objectives:• To assess the efficacy (progression free survival [PFS]) of DCC 2618 by independent radiologic review in patients with advanced gastrointestinal stromal tumors (GIST) who have received prior therapiesKey Secondary Objectives:•…
Primary- Part A: Evaluation of pharmacodynamic (PD) interaction between steady-state treatment with padsevonil (PSL) and ethanol- Part B: Evaluation of pharmacokinetic (PK) interaction between steady-state treatment with padsevonil (PSL) and…
Part 1 Single Ascending Dose (SAD)- To evaluate the safety and tolerability of a single oral dose of prodrug, ABX-002, in healthy adult subjectsPart 2 Multiple Ascending Dose (MAD)-To evaluate the safety and tolerability of once daily oral doses 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…
* 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…
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…
• To evaluate the safety and tolerability of THB001 in cold induced chronic urticaria patients
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…