First in Human Phase 1 Ascending Dose Study of PanChol in Healthy Volunteers

Phase 1 Unknown 53 enrolled Brigham and Women's Hospital

RandomizedParallel-groupTriple-blindPrevention

Summary

This study is a first-in-human, Phase 1 study of the safety, tolerability, and immunogenicity of PanChol in healthy volunteers. There will be three modules in this clinical trial assessing dosing, safety, and immunogenicity: 1. a fixed dose-ranging module, 2. an adaptive dose-finding/optimization module, and 3. a placebo-controlled expansion module.

Timeline

Start: 2022-12-12
Primary completion: 2024-12-01
Completion: 2025-12-01

Publications

Leitner DR, Walsh SR, Suzuki M, Desjardins M, Hannaford A, Sherman AC, Levine H, Carr L, Hammerness E, Osaki A, Sullivan E, Wang B, Balazs GI, Park Chang JB, Slater DM, Puri N, Kuehl CJ, Chen WH, Harris JB, Piantadosi S, Baden LR, Waldor MK; PanChol study group. Safety and immunogenicity of PanChol, a single-dose live-attenuated oral cholera vaccine: results from a phase 1a, double-blind, randomised, placebo-controlled trial. Lancet Infect Dis. 2026 May;26(5):497-509. doi: 10.1016/S1473-3099(25)00682-6. Epub 2026 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PanChol	Vaccine	10000 unknown	Oral
Subject	PanChol	Vaccine	100000 unknown	Oral
Subject	PanChol	Vaccine	1e+06 unknown	Oral
Subject	PanChol	Vaccine	1e+07 unknown	Oral
Subject	PanChol	Vaccine	2e+07 unknown	Oral
Subject	PanChol	Vaccine	1e+08 unknown	Oral
Subject	PanChol	Vaccine	2e+08 unknown	Oral
Subject	PanChol	Vaccine	1e+09 unknown	Oral
Subject	PanChol	Vaccine	1e+10 unknown	Oral

First in Human Phase 1 Ascending Dose Study of PanChol in Healthy Volunteers

Summary

Timeline

Publications

Drugs

Indications