Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers

Phase 1 Completed 80 enrolled Foresee Pharmaceuticals Co., Ltd. QPS-Qualitix · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, placebo controlled, single and multiple ascending dose study to assess the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects. Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).

Timeline

Start: 2015-06
Primary completion: 2018-12
Completion: 2018-12

Publications

Abd-Elaziz K, Voors-Pette C, Wang KL, Pan S, Lee Y, Mao J, Li Y, Chien B, Lau D, Diamant Z. First-in-Man Safety, Tolerability, and Pharmacokinetics of a Novel and Highly Selective Inhibitor of Matrix Metalloproteinase-12, FP-025: Results from Two Randomized Studies in Healthy Subjects. Clin Drug Investig. 2021 Jan;41(1):65-76. doi: 10.1007/s40261-020-00981-9. Epub 2020 Dec 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADERAMASTAT	Small molecule	50 mg	Oral
Subject	ADERAMASTAT	Small molecule	200 mg	Oral
Subject	ADERAMASTAT	Small molecule	450 mg	Oral
Subject	ADERAMASTAT	Small molecule	800 mg	Oral

Indications

No indication recorded.