RECRUITING

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

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Conditions

Rift Valley FeverHealthy volunteerRift Valley fever virus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-04-02
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06925919

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy male or female
  2. * Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m\^2, inclusively
  3. * Female participants must not be pregnant, breastfeeding or intend to become pregnant through 1 year post-administration
  4. * Male subjects must agree to not cause pregnancy or donate sperm for 1 year post-administration
  5. * Non-smoker
  6. * Agree to abstain from alcohol for 72 hours and caffeine for 48 hours prior to administration and during the confinement period
  7. * Agree to not donate blood or plasma during study participation
  8. * Agree not to travel to Rift Valley fever virus (RVFV) endemic areas during participation
  1. * Known history of RVFV infection
  2. * Previous receipt of RVFV vaccine
  3. * Illness with fever within 5 days prior to administration
  4. * History of malignancy within prior 5 years
  5. * History of significant cardiovascular, pulmonary, gastrointestinal, liver, kidney, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic disease
  6. * History of hypersensitivity reaction
  7. * History or clinical evidence of alcohol abuse
  8. * Human immunodeficiency virus (HIV) positive
  9. * Hepatitis C virus positive
  10. * Hepatitis B virus positive
  11. * Received immunoglobulin or antibody product within 6 months of administration
  12. * Vaccine within 28 days of administration
  13. * Received investigational agent within 3 months or \< 5 half-lives (whichever is longer) prior to administration
  14. * Donation of plasma, 1 unit or \> 500 mL blood donation in 56 days prior to administration

Contacts and Locations

Study Contact

Main Contact
CONTACT
866-461-2526
ptinfo@altasciences.com

Study Locations (Sites)

Altasciences Clinical Los Angeles
Cypress, California, 90630
United States

Collaborators and Investigators

Sponsor: IDBiologics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-02
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-04-02
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Healthy volunteer
  • Rift Valley fever virus

Additional Relevant MeSH Terms

  • Rift Valley Fever