NCT06925919

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: IDBiologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Rift Valley Fever

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-02
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-04-13
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study