Rift Valley FeverPhase 1NCT06925919
Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
A Phase 1 study testing IDB-011 dose level 1, IDB-011 dose level 2 and IDB-011 dose level 3 in people with Rift Valley Fever, run by IDBiologics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Rift Valley Fever
- What is being tested?
- IDB-011 dose level 1, IDB-011 dose level 2 and IDB-011 dose level 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2025to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Los Angeles
Cypress, California, 90630
About this study
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
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.
Read the 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.
- Conditions
- Rift Valley Fever
- Being tested
- IDB-011 dose level 1, IDB-011 dose level 2, IDB-011 dose level 3, IDB-011 dose level 4, IDB-011 dose level 5
- Keywords
- Healthy volunteer, Rift Valley fever virus
- Medical subject headings
- Rift Valley Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDB-011 dose level 1Drug
IDB-774 + IDB-898
IDB-011 dose level 2Drug
IDB-774 + IDB-898
IDB-011 dose level 3Drug
IDB-774 + IDB-898
IDB-011 dose level 4Drug
IDB-774 + IDB-898
IDB-011 dose level 5Drug
IDB-774 + IDB-898
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Experimental: IDB-011 Cohort 1 | Experimental | IDB-011 dose level 1 Receives: Drug: IDB-011 dose level 1 |
| Experimental: IDB-011 Cohort 2 | Experimental | IDB-011 dose level 2 Receives: Drug: IDB-011 dose level 2 |
| Experimental: IDB-011 Cohort 3 | Experimental | IDB-011 dose level 3 Receives: Drug: IDB-011 dose level 3 |
| Experimental: IDB-011 Cohort 4 | Experimental | IDB-011 dose level 4 Receives: Drug: IDB-011 dose level 4 |
| Experimental: IDB-011 Cohort 5 | Experimental | IDB-011 dose level 5 Receives: Drug: IDB-011 dose level 5 |
| Comparator: Placebo | Placebo comparator | Normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety and tolerability
Safety to be measured via occurrence and severity of adverse events
Measured: Through 1 year from administration
Secondary outcomes (2)
Characterize pharmacokinetic profile
Concentration in serum over time
Measured: Through 1 year from administration
Evaluate immunogenicity
Measurement of IDB-011 neutralizing antibodies in serum
Measured: Through 1 year from administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start2 Apr 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rift Valley FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDBiologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925919
- Sponsor's protocol ID
- IDB-RVFV-101
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06925919
- Acronym / sponsor ID
- IDB-RVFV-101
- Conditions
- Rift Valley Fever
- Keywords
- Healthy volunteer, Rift Valley fever virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IDBiologics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental: IDB-011 Cohort 1 | Experimental | Drug: IDB-011 dose level 1IDB-011 dose level 1 |
| Experimental: IDB-011 Cohort 2 | Experimental | Drug: IDB-011 dose level 2IDB-011 dose level 2 |
| Experimental: IDB-011 Cohort 3 | Experimental | Drug: IDB-011 dose level 3IDB-011 dose level 3 |
| Experimental: IDB-011 Cohort 4 | Experimental | Drug: IDB-011 dose level 4IDB-011 dose level 4 |
| Experimental: IDB-011 Cohort 5 | Experimental | Drug: IDB-011 dose level 5IDB-011 dose level 5 |
| Comparator: Placebo | Placebo comparator | Other: PlaceboNormal saline |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDB-011 dose level 1IDB-774 + IDB-898 | Drug | Experimental: IDB-011 Cohort 1 |
| IDB-011 dose level 2IDB-774 + IDB-898 | Drug | Experimental: IDB-011 Cohort 2 |
| IDB-011 dose level 3IDB-774 + IDB-898 | Drug | Experimental: IDB-011 Cohort 3 |
| IDB-011 dose level 4IDB-774 + IDB-898 | Drug | Experimental: IDB-011 Cohort 4 |
| IDB-011 dose level 5IDB-774 + IDB-898 | Drug | Experimental: IDB-011 Cohort 5 |
| PlaceboNormal saline | Other | Comparator: Placebo |
Primary outcome
Evaluation of safety and tolerability
Time frame: Through 1 year from administration
Safety to be measured via occurrence and severity of adverse events
2 secondary outcomes
Characterize pharmacokinetic profile
Time frame: Through 1 year from administration
Evaluate immunogenicity
Time frame: Through 1 year from administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IDB-011 dose level 1, IDB-011 dose level 2 and IDB-011 dose level 3 in people with Rift Valley Fever, run by IDBiologics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of safety and tolerability (time frame: Through 1 year from administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.