Clinical trial NCT06925919: Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Rift Valley Fever
Keywords: Healthy volunteer
Rift Valley fever virus
Lead sponsor: IDBiologics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
First posted: 2025-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of safety and tolerability
timeFrame: Through 1 year from administration
Secondary outcomes:
measure: Characterize pharmacokinetic profile
timeFrame: Through 1 year from administration
measure: Evaluate immunogenicity
timeFrame: Through 1 year from administration
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles
state: California
Study officials:
References: