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

Last updated: April 7, 2025
Sponsor: IDBiologics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Fungal Infections

Systemic Fungal Infections

Treatment

Placebo

IDB-011 dose level 3

IDB-011 dose level 1

Clinical Study ID

NCT06925919
IDB-RVFV-101
  • Ages 18-64
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 pregnantthrough 1 year post-administration

  • Male subjects must agree to not cause pregnancy or donate sperm for 1 yearpost-administration

  • Non-smoker

  • Agree to abstain from alcohol for 72 hours and caffeine for 48 hours prior toadministration 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 duringparticipation

Exclusion

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 islonger) prior to administration

  • Donation of plasma, 1 unit or > 500 mL blood donation in 56 days prior toadministration

Study Design

Total Participants: 40
Treatment Group(s): 6
Primary Treatment: Placebo
Phase: 1
Study Start date:
April 02, 2025
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Altasciences Clinical Los Angeles

    Cypress, California 90630
    United States

    Active - Recruiting

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