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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
IDB-774 + IDB-898
IDB-774 + IDB-898
IDB-774 + IDB-898
Altasciences Clinical Los Angeles
Cypress, California, United States
RECRUITINGEvaluation of safety and tolerability
Safety to be measured via occurrence and severity of adverse events
Time frame: Through 1 year from administration
Characterize pharmacokinetic profile
Concentration in serum over time
Time frame: Through 1 year from administration
Evaluate immunogenicity
Measurement of IDB-011 neutralizing antibodies in serum
Time frame: Through 1 year from administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IDB-774 + IDB-898
IDB-774 + IDB-898
Normal saline