Rift Valley Fever
Conditions
Keywords
Healthy volunteer, Rift Valley fever virus
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.
Interventions
DRUGIDB-011 dose level 1
IDB-774 + IDB-898
DRUGIDB-011 dose level 2
IDB-774 + IDB-898
DRUGIDB-011 dose level 3
IDB-774 + IDB-898
DRUGIDB-011 dose level 4
IDB-774 + IDB-898
DRUGIDB-011 dose level 5
IDB-774 + IDB-898
OTHERPlacebo
Normal saline
Sponsors
IDBiologics, Inc.
Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of safety and tolerability | Through 1 year from administration | Safety to be measured via occurrence and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize pharmacokinetic profile | Through 1 year from administration | Concentration in serum over time |
| Evaluate immunogenicity | Through 1 year from administration | Measurement of IDB-011 neutralizing antibodies in serum |
Countries
United States
Outcome results
None listed