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Clinical Trials in the USA / NCT06925919
Active, not recruiting Phase 1

Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011

NCT06925919 · tracked via the Priya Life Science USA tracker
Sponsor
IDBiologics, Inc.
Phase
Phase 1
Started
2025-04-02
Last updated
2026-03-25

Condition(s) studied

Rift Valley Fever

Investigational drug(s) / intervention(s)

IDB-011 dose level 1IDB-011 dose level 2IDB-011 dose level 3IDB-011 dose level 4IDB-011 dose level 5Placebo

IDB-011 dose level 1: IDB-774 + IDB-898

IDB-011 dose level 2: IDB-774 + IDB-898

IDB-011 dose level 3: IDB-774 + IDB-898

IDB-011 dose level 4: IDB-774 + IDB-898

IDB-011 dose level 5: IDB-774 + IDB-898

Placebo: Normal saline

Study 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 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)

Trial sites (1)

FacilityCityRegionStatus
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.

View NCT06925919 on ClinicalTrials.gov ↗ ← All trials in the USA