A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease

Phase 1/2 Completed 39 enrolled Regenera Pharma Ltd Syneos Health · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to investigate the safety, tolerability, cognitive, and behavioural effects of RPh201. The study will be divided into three parts: A, B, and C (NOT Performed)

Timeline

Start: 2012-01
Primary completion: 2015-06
Completion: 2015-06

Publications

Results Hazan Z, Adamsky K, Lucassen A, Levin LA. A First-in-Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers. Clin Pharmacol Drug Dev. 2020 Apr;9(3):366-374. doi: 10.1002/cpdd.720. Epub 2019 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RPh201	Unknown	5 mg	Subcutaneous
Subject	RPh201	Unknown	10 mg	Subcutaneous
Subject	RPh201	Unknown	20 mg	Subcutaneous

Indications

No indication recorded.