NCT06925919

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
5mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Apr 2025Oct 2026

Study Start

First participant enrolled

April 2, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

April 7, 2025

Last Update Submit

March 23, 2026

Conditions

Rift Valley Fever

Keywords

Healthy volunteerRift Valley fever virus

Outcome Measures

Primary Outcomes (1)

  • Evaluation of safety and tolerability

    Safety to be measured via occurrence and severity of adverse events

    Through 1 year from administration

Secondary Outcomes (2)

  • Characterize pharmacokinetic profile

    Through 1 year from administration

  • Evaluate immunogenicity

    Through 1 year from administration

Study Arms (6)

Experimental: IDB-011 Cohort 1

EXPERIMENTAL

IDB-011 dose level 1

Drug: IDB-011 dose level 1

Experimental: IDB-011 Cohort 2

EXPERIMENTAL

IDB-011 dose level 2

Drug: IDB-011 dose level 2

Experimental: IDB-011 Cohort 3

EXPERIMENTAL

IDB-011 dose level 3

Drug: IDB-011 dose level 3

Experimental: IDB-011 Cohort 4

EXPERIMENTAL

IDB-011 dose level 4

Drug: IDB-011 dose level 4

Experimental: IDB-011 Cohort 5

EXPERIMENTAL

IDB-011 dose level 5

Drug: IDB-011 dose level 5

Comparator: Placebo

PLACEBO COMPARATOR

Normal saline

Other: Placebo

Interventions

IDB-011 dose level 1DRUG

IDB-774 + IDB-898

Experimental: IDB-011 Cohort 1
IDB-011 dose level 2DRUG

IDB-774 + IDB-898

Experimental: IDB-011 Cohort 2
IDB-011 dose level 3DRUG

IDB-774 + IDB-898

Experimental: IDB-011 Cohort 3
IDB-011 dose level 5DRUG

IDB-774 + IDB-898

Experimental: IDB-011 Cohort 5
PlaceboOTHER

Normal saline

Comparator: Placebo
IDB-011 dose level 4DRUG

IDB-774 + IDB-898

Experimental: IDB-011 Cohort 4

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altasciences Clinical Los Angeles

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Rift Valley Fever

Condition Hierarchy (Ancestors)

Hepatitis, Viral, AnimalHepatitis, AnimalInfectionsMosquito-Borne DiseasesVector Borne DiseasesArbovirus InfectionsVirus DiseasesBunyaviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralHepatitisLiver DiseasesDigestive System DiseasesAnimal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 13, 2025

Study Start

April 2, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)