drugset

drugset / Trial / NCT05232175

Clinical Study of ALT-BB4 to Determine Tolerance, Safety and Pharmacokinetics in Healthy Volunteer

NCT05232175 ↗

Phase 1 Completed 290 enrolled Alteogen, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase I Study to Evaluate the Tolerance, Safety and Pharmacokinetics of ALT-BB4 in Healthy Volunteers

Timeline

Start: 2022-01-18
Primary completion: 2022-08-24
Completion: 2022-08-24

Publications

Lee JS, Kim W, Won CH, Lee YW, Lee S, Won H, Park SJ, Lee S, Kim SH, Yang J, Bahn G, Lee DH. The Safety, Tolerability, and Pharmacokinetics of ALT-BB4 (A Novel Recombinant Hyaluronidase): A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study in Healthy Volunteers. Dermatol Ther (Heidelb). 2025 Nov;15(11):3301-3311. doi: 10.1007/s13555-025-01507-x. Epub 2025 Sep 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ALT-BB4	Protein / enzyme biologic	—	Other

Indications

No indication recorded.