13 results
To validate that OTR4120 will improve the healing of chronic ulcers.
The study primary goal is to determine the effectiveness of a single infusion of 1 x 10E13 DRP MYDICAR® in the coronary arteries in addition to an optimal HF regimen in patients with ischemic or non-ischemic cardiomyopathy and moderate to advanced…
Objective: To demonstrate the efficacy of a novel matrix therapy based technology that creates improved wound healing in a clinical donor site model.
Primary objective:- Disease free survival (DFS)Secondary objective:- Safety & tolerability- Overall survival (OS)Exploratory objective:- Association between HPV subtypes and efficacy- Patient reported outcomes (PRO)Please refer to section 1…
Primary objectives: 1. To assess the effect of experimental immunization with GA2 sporozoites by mosquito bite with and without co-administration of different adjuvants on the pre-patent period after controlled human malaria infection (CHMI).2. To…
Primary Efficacy Objectives:To ascertain whether the overall survival of subjects randomized to Arm V+G (PROSTVAC-V/F plus GM-CSF) or to Arm V (PROSTVAC-V/F) is superior to that from subjects randomized to Arm P (placebo control).Secondary Efficacy…
- To assess the safety and tolerability of live-attenuated RSV vaccine in healthy adults.- To assess the immunogenicity of the live-attenuated RSV vaccine (systemic and mucosal immunity) - To assess the viral load/shedding of the live-attenuated RSV…
The study is divided in Stage A and BGA1 stage A1. To determine the safety and tolerability of direct venous inoculation of PfSPZ-GA1 in healthy volunteers.GA1 stage B Primary objective:1. To determine the safety, and tolerability of PfSPZ-…
Phase 1 • Primary objective: to determine the safety and tolerability, including the attenuation phenotype of a novel late-arresting GAP, named GA2 parasite, administered by sequentially increasing numbers of mosquito bites.• Secondary objective: to…
Part A (Single Ascending Dose):Primary: To assess the safety and tolerability of single oral doses of PRAX-628 Secondary: To evaluate the pharmacokinetics (PK) of single oral doses of PRAX-628 Part B (Multiple Ascending Dose):Primary: To assess the…
• To investigate the safety and tolerability of two ascending dose levels and two different dosing intervals of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects.• To investigate safety and tolerability of three intramuscular dose…
Primary Objectives:To evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression free survival (PFS) (response evaluation by blinded independent central review using modified…
To assess the safety and reactogenicity of HB-101.To assess the immunogenicity of HB-101.