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

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.

Conditions

Rift Valley Fever

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Study Overview

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Study Details

Study overview

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.

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety Tolerability and Pharmacokinetics of IDB-011 (IDB-774+IDB-898) in Healthy Adults

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

Condition
Rift Valley Fever
Intervention / Treatment

-

Contacts and Locations

Cypress

Altasciences Clinical Los Angeles, Cypress, California, United States, 90630

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

IDBiologics, Inc.,

Study Record Dates

2026-10