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

RECRUITINGPhase 1Sponsored by IDBiologics, Inc.
Actively Recruiting
PhasePhase 1
SponsorIDBiologics, Inc.
Started2025-04-02
Est. completion2025-10
Eligibility
Age18 Years – 64 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06925919

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

Age: 18 Years – 64 YearsHealthy 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

Conditions2

Liver DiseaseRift Valley Fever

Locations1 site

Altasciences Clinical Los Angeles
Cypress, California, 90630

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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