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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Evaluation of safety and tolerability — Through 1 year from administration Safety to be measured via occurrence and severity of adverse events
Trial sites (1)
Facility
City
Region
Status
Altasciences Clinical Los Angeles
Cypress
California
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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