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

March 23, 2026 updated by: IDBiologics, Inc.

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of IDB-011 (IDB-774+IDB-898) in Healthy Adults

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 volunteers aged 18-64. IDB-011 is comprised of IDB-774 and IDB-898, which will be administered as separate, consecutive intramuscular injections.

Volunteers will be recruited into sequential dosing cohorts. Within each cohort, eligible volunteers will be randomly allocated (6:2) to receive either IDB-011 or placebo (0.9% normal saline). A sentinel dosing scheme will be employed for the first 2 volunteers in each dosing cohort.

Volunteers will stay in a clinical research unit for up to 4 consecutive days and be followed for up to 1 year.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • Altasciences Clinical Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: IDB-011 Cohort 1
IDB-011 dose level 1
Drug: IDB-011 dose level 1
IDB-774 + IDB-898
Experimental: Experimental: IDB-011 Cohort 2
IDB-011 dose level 2
Drug: IDB-011 dose level 2
IDB-774 + IDB-898
Experimental: Experimental: IDB-011 Cohort 3
IDB-011 dose level 3
Drug: IDB-011 dose level 3
IDB-774 + IDB-898
Experimental: Experimental: IDB-011 Cohort 4
IDB-011 dose level 4
Drug: IDB-011 dose level 4
IDB-774 + IDB-898
Experimental: Experimental: IDB-011 Cohort 5
IDB-011 dose level 5
Drug: IDB-011 dose level 5
IDB-774 + IDB-898
Placebo Comparator: Comparator: Placebo
Normal saline
Other: Placebo
Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of safety and tolerability
Time Frame: Through 1 year from administration
Safety to be measured via occurrence and severity of adverse events
Through 1 year from administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize pharmacokinetic profile
Time Frame: Through 1 year from administration
Concentration in serum over time
Through 1 year from administration
Evaluate immunogenicity
Time Frame: Through 1 year from administration
Measurement of IDB-011 neutralizing antibodies in serum
Through 1 year from administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IDBiologics, Inc.

Collaborators

Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDB-RVFV-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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