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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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

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

Other trials in United States

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

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 groups in NCT06925919
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.

2 Apr 2025Oct 2026

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
RVF and Other Emerging Infectious Diseases in East and Central Africa
Rift Valley Fever, Hemorrhagic Fevers, Viral
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Active, not recruitingPhase 2
Safety and Immunogenicity of a Candidate Rift Valley Fever Vaccine (RVF003)
Rift Valley Fever
RecruitingPhase 2
Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Rift Valley Fever

All Rift Valley Fever trials