Status:
RECRUITING
Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
Lead Sponsor:
IDBiologics, Inc.
Collaborating Sponsors:
Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
Conditions:
Rift Valley Fever
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
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 a...
Detailed 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 voluntee...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06925919
Start Date
April 2 2025
End Date
October 1 2026
Last Update
April 13 2025
Active Locations (1)
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1
Altasciences Clinical Los Angeles
Cypress, California, United States, 90630