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drugset / Trial / NCT06460064

First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP

NCT06460064 ↗

Phase 1 Completed 144 enrolled Sumitomo Pharma Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study is a single center, randomized, double-blind, placebo-controlled, dose-finding, FIH, Phase 1 study to assess the safety, tolerability, and immunogenicity of the adjuvanted Universal Influenza Vaccine (fH1/DSP-0546LP) after IM administrations in healthy adults.

Timeline

Start
2024-06-26
Primary completion
2026-03-31
Completion
2026-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject DSP-0546LP Unknown 2.5 ug Intramuscular
Subject DSP-0546LP Unknown 5 ug Intramuscular
Subject DSP-0546LP Unknown 10 ug Intramuscular
Subject fH1 Vaccine 2 ug Intramuscular
Subject fH1 Vaccine 8 ug Intramuscular

Indications

influenza