11 results
Primary study objective Is the reduction of 1 to several antipsychotic antipsychotic associated with more relapse? Relapse is measured with the Brief Psychiatric Rating Scale (BPRS) and is defined as: - An absolute increase of> 2 on one of…
Primary Objective• To evaluate the local safety and tolerability of INM-755 cream following repeated once-daily topical applications for 14 consecutive days on wounded skin of healthy volunteers. Secondary Objectives• To evaluate the systemic safety…
4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…
Primary Objectives: - To evaluate the safety in mother and neonate/infant of nipocalimab administered to pregnant women at high risk for EOS-HDFN. - To evaluate the efficacy of nipocalimab as measured by proportion of patients with live birth at or…
The purpose of this study is to provide remdesivir (RDV) to participants with moderate COVID-19. The primary objective of this study is as follows: To evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with…
The overarching goal of this study is to improve adequate resection of oral cancer. We will perform a clinical trial to determine the optimal dose of cRGD-ZW800-1 and to investigate the feasibility of intraoperative FLI to adequately assess tumor…
To assess the feasibility of cRGD-ZW800-1 to visualize tumors in real-time using dedicated NIR fluorescence imaging systems
Part A (Healthy volunteers)Primary:• To assess safety and tolerability of multiple doses of NX210cSecondary• To evaluate the pharmacokinetic (PK) profile of NX210c in plasma after multiple doses. • To evaluate the exposure of NX210c in cerebrospinal…
DOSE EXPLORATION:Primary:To determine the safety and tolerability of GSK2857916 in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each sub-study combination treatment.Secondary:…
Primary objective-To compare rate of Minimal Residual Disease (MRD) negativity by NGS between Isa-KRd and KRd in post ASCT consolidation treatment.Key secondary objectives- Rate of MRD negativity after induction by NGS- To compare progression-free…
Part IPrimary: • To evaluate safety and tolerability of ODM-111 in single oral escalating doses compared to placeboSecondary: • To evaluate pharmacokinetics (PK) and pharmacodynamic (PD) effects of ODM-111 after administration of single escalating…