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news.Transition Therapeutics' lead Alzheimer's disease drug candidate AZD-103 has performed well in a Canadian phase I clinical trial, proving safe and well tolerated in health volunteers.
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AZD-103 is part of an emerging class of disease-modifying drugs that have the potential to both reduce disease progression and improve symptoms such as cognitive function. In addition, AZD-103 is well positioned as a potential Alzheimer’s therapy as it can be taken orally, crosses the blood brain barrier and has shown a favorable safety profile to date.
In the trial, 13 healthy volunteers were dosed in to evaluate the pharmacokinetics, safety and tolerability of a single ascending dose of AZD-103. The study showed that AZD-103 has a favorable pharmacokinetic profile that supports the targeted therapeutic dosing levels for AZD-103.
The safety data, meanwhile, indicated that AZD-103 was well tolerated by all subjects. No safety concerns or significant adverse events were observed in the study.
The phase I clinical development program for AZD-103 consists of a series of phase I studies to establish the drug candidate’s safety, tolerability and pharmacokinetic profile. Transition recently received FDA clearance to commence a phase I study to examine higher doses of AZD-103.
Transition also hopes to be in a position to submit an application for a phase II trial in Alzheimer’s disease patients in early 2007.