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A Study of RBI-4000 in Healthy Participants

NCT06048770 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2024-08-06

No results posted yet for this study

Summary

The primary purpose of the study is to evaluate the safety, reactogenicity, and immunogenicity of RBI-4000 administered at various dose levels via intramuscular injection and to determine the lowest dose of RBI-4000 necessary to elicit the rabies virus neutralizing antibody titer of equal or greater than (\>=) 0.5 international unit per milliliter (IU/mL).

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

RBI-4000

RBI-4000 intramuscular injection.

BIOLOGICAL

RabAvert

RabAvert intramuscular injection.

Sponsors & Collaborators

  • Replicate Bioscience

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06048770 on ClinicalTrials.gov