Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
Running, not enrolling · Phase 1 · Has a placebo group
Conditions studied: Rift Valley Fever
In brief
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.
Key facts
- Study ID
- NCT06925919
- Run by
- IDBiologics, Inc.
- People needed
- 40
- Starts
- 2025-04-02
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-03-25
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Altasciences Clinical Los Angeles — Cypress, California, United States
Full record on ClinicalTrials.gov
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