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

NCT06925919 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-25

No results posted yet for this 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.

Conditions

  • Rift Valley Fever

Interventions

DRUG

IDB-011 dose level 1

IDB-774 + IDB-898

DRUG

IDB-011 dose level 2

IDB-774 + IDB-898

DRUG

IDB-011 dose level 3

IDB-774 + IDB-898

DRUG

IDB-011 dose level 4

IDB-774 + IDB-898

DRUG

IDB-011 dose level 5

IDB-774 + IDB-898

OTHER

Placebo

Normal saline

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • IDBiologics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-02
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06925919 on ClinicalTrials.gov