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Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
Sponsor: IDBiologics, Inc.
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.
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of IDB-011 (IDB-774+IDB-898) in Healthy Adults
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-04-02
Completion Date
2026-10
Last Updated
2026-03-25
Healthy Volunteers
Yes
Conditions
Interventions
IDB-011 dose level 1
IDB-774 + IDB-898
IDB-011 dose level 2
IDB-774 + IDB-898
IDB-011 dose level 3
IDB-774 + IDB-898
IDB-011 dose level 4
IDB-774 + IDB-898
IDB-011 dose level 5
IDB-774 + IDB-898
Placebo
Normal saline
Locations (1)
Altasciences Clinical Los Angeles
Cypress, California, United States