Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-02

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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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

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Rift Valley Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind

Intervention Type OTHER

Normal saline

Normal saline

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes