Evaluating a new treatment for Rift Valley Fever
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of IDB-011 (IDB-774+IDB-898) in Healthy Adults
This study is testing a new treatment for Rift Valley Fever in healthy adults to see if it's safe and how well it works.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | IDBiologics, Inc. Industry-sponsored |
| Locations | 1 site (Cypress, California) |
| Trial ID | NCT06925919 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of IDB-011, a new treatment for Rift Valley Fever, in healthy adult volunteers aged 18-64. Participants will receive either IDB-011 or a placebo through intramuscular injections in a randomized, double-blind manner. The study will involve sequential dosing cohorts, with volunteers monitored in a clinical research unit for up to four days and followed for a year. The trial aims to gather critical data on the treatment's effects and safety profile.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-64 with a BMI between 18.0 and 30.0 who meet specific health criteria.
Not a fit: Patients with a known history of Rift Valley Fever infection or previous vaccination against it will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new preventive option against Rift Valley Fever.
How similar studies have performed: While this approach is novel, similar studies targeting viral infections have shown promise in early phases.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cypress, California
- Altasciences Clinical Los Angeles — Cypress, California, United States (Recruiting)
Study contacts
- Study coordinator: Main Contact
- Email: ptinfo@altasciences.com
- Phone: 866-461-2526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.