Clinical Trial Search

Primary: Minimum Number of Vaccine Doses Created Using Participant Tumor Sample — 6 doses

Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness — 4; 1; 0; 0 Participants

Primary: Ex-vivo Inhibition Of Platelet Aggregation (IPA) — 0.82; 1.21; 1.03; 4.42 ratio

Primary: Assessment of Treatment Emergent Adverse Events (AEs) Meeting Dose-limiting Toxicity (DLT) Criteria. — 0; 0; 0; 0 Number of DLTs

Primary: Safety and Tolerability Evaluation — 1; 6; 1; 3 Participants

Primary: Number of Patients With Dose Limiting Toxicities (DLTs) and Number of Patients With Adverse Events — 0; 0; 0; 3 Participants

Primary: Number of Subjects Reporting Adverse Events Through 30 Days After Dosing — 3; 5; 3; 6 Participants

Primary: Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. — 10; 11; 13; 5 Adverse events

Primary: Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) — 0; 0; 0; 0 Participants

Primary: Number of Participants With Dose Limiting Toxicities (DLTs) - Arms A, B and C — 0; 0; 0; 0 Participants

Primary: Post-operative Opioid Pain Medication Dose — 26.99; 31.12; 28.65; 33.15 mg of morphine equivalent dose (MED)

Primary: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form — 2060 h*ng/mL

Primary: Cmax of Diazepam After Single Intranasal Doses of NRL-1 (Diazepam Nasal Spray) Administered to Epilepsy Subjects During the Ictal or Peri-ictal Period — 135; 153 ng/mL

Primary: Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B — 7571; 8377 Day*micrograms per milliliter — p=0.4265

Primary: Mean Serum Concentrations (Cmax) for Open-label Palivizumab (Part 1) on Day 12. — 71.2 μg/mL