A Study of RBI-4000 in Healthy Participants

Phase 1 Terminated 89 enrolled Replicate Bioscience

RandomizedSequentialSingle-blindOther

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).

Timeline

Start: 2023-09-01
Primary completion: 2024-07-31
Completion: 2024-07-31

Outcome

Outcome not reported

Stopped (Business): “Strategic business decision (not related to safety, efficacy, or quality)”

Publications

Maine CJ, Picarda G, Miyake-Stoner SJ, Essink B, Somodevilla G, Sparks J, Geall AJ, Wang NS, Goldberg Z, Aliahmad P. Durability of next-generation self-replicating RNA vaccine RBI-4000: a phase 1, randomized open label clinical trial. Commun Med (Lond). 2025 Sep 24;5(1):392. doi: 10.1038/s43856-025-01147-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RBI-4000	Unknown	0.1 ug	Intramuscular
Subject	RBI-4000	Unknown	1 ug	Intramuscular
Subject	RBI-4000	Unknown	10 ug	Intramuscular
Comparator	Rabipur	Vaccine	1 ml	Intramuscular

Indications

No indication recorded.