A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of IDB-011 (IDB-774+IDB-898) in Healthy Adults
Phase 1 randomized, double-blind, placebo-controlled trial to evaluate safety, tolerability, pharmacokinetics (PK) and immunogenicity of IDB-011 following intramuscular (IM )administration of single ascending doses to healthy adult participants.
• Healthy male or female
• Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m\^2, inclusively
• Female participants must not be pregnant, breastfeeding or intend to become pregnant through 1 year post-administration
• Male subjects must agree to not cause pregnancy or donate sperm for 1 year post-administration
• Non-smoker
• Agree to abstain from alcohol for 72 hours and caffeine for 48 hours prior to administration and during the confinement period
• Agree to not donate blood or plasma during study participation
• Agree not to travel to Rift Valley fever virus (RVFV) endemic areas during participation