Overview
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.
Description
This is a randomized, double blind, placebo-controlled, dose escalation, first-in-human, Phase I clinical trial to assess the safety, tolerability, PK and immunogenicity of IDB-011 in healthy volunteers aged 18-64. IDB-011 is comprised of IDB-774 and IDB-898, which will be administered as separate, consecutive intramuscular injections.
Volunteers will be recruited into sequential dosing cohorts. Within each cohort, eligible volunteers will be randomly allocated (6:2) to receive either IDB-011 or placebo (0.9% normal saline). A sentinel dosing scheme will be employed for the first 2 volunteers in each dosing cohort.
Volunteers will stay in a clinical research unit for up to 4 consecutive days and be followed for up to 1 year.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- Known history of RVFV infection
- Previous receipt of RVFV vaccine
- Illness with fever within 5 days prior to administration
- History of malignancy within prior 5 years
- History of significant cardiovascular, pulmonary, gastrointestinal, liver, kidney, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic disease
- History of hypersensitivity reaction
- History or clinical evidence of alcohol abuse
- Human immunodeficiency virus (HIV) positive
- Hepatitis C virus positive
- Hepatitis B virus positive
- Received immunoglobulin or antibody product within 6 months of administration
- Vaccine within 28 days of administration
- Received investigational agent within 3 months or < 5 half-lives (whichever is longer) prior to administration
- Donation of plasma, 1 unit or > 500 mL blood donation in 56 days prior to administration