14 results
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- 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…
Primary• To investigate the safety and tolerability of multiple oral doses of DNL343 in participants with ALSSecondary• To characterize the PK of DNL343 in plasma following single and multiple oral doses• To characterize the concentration of DNL343…
Primary objectivesThis Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis and consists of 2 sequential periods - an initial double-blind placebo-controlled period of minimum 72 weeks followed by a double-blind…
Primary objectives:To compare the efficacy of Adagrasib in combination with cetuximab versus chemotherapy (FOLFIRI or mFOLFOX6) administered in the second-line treatment setting to patients with CRC with KRAS G12C mutation.Secondary objectives:• To…
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…
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…
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:…
To evaluate the safety and tolerability of ENX-102 following repeated doses in healthy volunteers
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…
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 single ascending doses of UCB7853 administered as an iv infusion in healthy male study participantsTo evaluate the safety and tolerability of multiple (3 in total, given monthly) ascending doses of UCB7853…
Objectives Part A: • To evaluate the safety and tolerability of CIT-013 after administration of single, ascending, IV doses in healthy volunteers.• To evaluate the pharmacokinetics of CIT-013 after administration of single, ascending, IV doses in…