4 results
Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…
Primary: Document and characterize the severe toxicity and clinical activity of the recNY-ESO-1 + AS15 ASCI in patients with NY-ESO-1-positive metastatic cutaneous melanoma.Secondary: Document and characterize additional clinical indicators of…
The primary objective is to demonstrate the efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children (ages 4-17 years, inclusive…
Primary: To describe safety and tolerability during longer-term administration of AR101 and follow-up observation after the last dose of AR101.Secondary: - To assess the level of desensitization achievable through extended maintenance dosing of…