24 results
The primary objective of the study is:To evaluate efficacy of two doses of ESN364 versus placebo when administered for 12 weeks to decrease total testosterone (TT) levelsThe Secondary objectives are:To evaluate effect of two doses of ESN364 versus…
With intervention with bronchodilators (usual care bronchodilators for COPD subjects), in one study histamine and in one study steroids, we want to investigate the respons on inspiratory lung function parameter like the FIV1 and also investigate…
Primary ObjectivesPart 1 * Single Ascending DoseThe primary objective of the single ascending dose (SAD) part of the study is to characterize the safety and tolerability of a single dose of PTC857 in healthy subjects.Part 2 * Multiple Ascending…
Primary ObjectiveTo assess the tolerability and safety of single ascending oral doses of PHA-022121 administered after a standard meal and of a single 40 mg dose under fasted conditions in healthy adult subjects.To assess the PK characteristics of…
Part 1 - Single Ascending Dose (SAD):Primary objective:• To evaluate the safety and tolerability of single oral doses of THB001 in healthy subjects.Secondary objectives:• To characterize the plasma pharmacokinetic (PK) profile of single oral doses…
Primary objective:• To assess the mass balance of nanatinostat (ie, evaluate clearance mechanisms of nanatinostat and drug-related metabolites) following a single oral dose of [14C]-nanatinostat in patients with advanced cancer.Secondary objectives…
Primary objective:• To evaluate the safety and tolerability profile of single intravenous doses of AST-004 given as a short loading intravenous infusion followed by a 6-hour continuous intravenous (IV) infusion in healthy adult subjects.Secondary…
Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.Secundary:• To assess the safety and tolerability of VMX-C001 in a simulated emergency use setting.• To assess the…
PrimarySAD: - To evaluate the safety and tolerability of single ascending doses of ANX1502 in healthy participants.MAD: - To evaluate the safety and tolerability of multiple ascending doses of ANX1502 in healthy participants.SecondarySAD: - To…
Primary objectives: • To determine the safety and tolerability of a single administration and single-day IDR of intravenous GH002.• To determine the pharmacokinetics (PK) of 5-MeO-DMT in healthy volunteers following a single administration and…
Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…
Primary objective:• To investigate the effect of THB001 on the pharmacokinetics (PK) of caffeine, omeprazole and midazolam.Secondary objective:• To evaluate the safety and tolerability of THB001 co-administered with caffeine, omeprazole and…
Primary objective: To evaluate the safety and tolerability of single ascending i.v. doses of OMN6 in healthy young and elderly adult subjects.Secondary objective: To evaluate OMN6 PK in plasma following single ascending i.v. doses in healthy young…
Primary:1. To characterize the safety and tolerability of multiple oral doses of K-196 alone and in combination with naproxen/omeprazole in healthy subjects.Secondary:1. To assess the effects of K-196 compared to placebo on the proportion of…
Part 1 SAD:Primary objective: To evaluate the safety and tolerability of single ascending doses of ANXV in healthy subjects.Secondary objective: To determine the PK profile of single ascending doses of ANXV in healthy subjects.Part 2 MAD:Primary…
Primary objective:• To evaluate the safety and tolerability of single intravenous (i.v.) doses of XAB05 in healthy subjects.Secondary objective:• To characterize the plasma pharmacokinetic (PK) profile of single i.v. doses of XAB05 in healthy…
Primary objective:* To evaluate the safety of BYON5667 eye drops.Secondary objective:* To evaluate the tolerability of BYON5667 eye drops.
* to evaluate the safety and tolerability of Lu AF90103 following single ascending intravenous (i.v.) doses* to investigate the pharmacokinetics (PK) of Lu AF90103 (prodrug) and Lu AF88361 (drug) in plasma and cerebrospinal fluid (CSF) following…
Primary objective: - To evaluate the systemic absorption and pharmacokinetics of topically applied NT-077 Secondary objectives: - To evaluate the safety and tolerability of topically applied NT-077- To evaluate the pharmacodynamic effect on sweat…
Part 1:Primary objective:• To estimate the relative bioavailability of two THB001 formulations in healthy adults.Secondary objectives:• To determine the single-dose pharmacokinetics (PK) of THB001•HCl salt and THB001 free base formulations in…