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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1

Age range

18 years - 64 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

40 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

IDBiologics, Inc.

Study start

Apr 2, 2025 Actual

Primary completion

Oct 30, 2026 Actual

Study completion

Oct 30, 2026 Actual

First posted

Apr 13, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.