健康なボランティアとパーキンソン病患者を対象としたLY3962681の臨床試験
基本情報
- NCT ID
- NCT06565195
- ステータス
- 募集中
- 試験のフェーズ
- 第1相
- 試験タイプ
- 介入
- 目標被験者数
- 108
- 治験依頼者名
- Prevail Therapeutics
概要
The purpose of this study is to evaluate the safety, tolerability, and PK/PD of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study will be comprised of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Doses (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid (aCSF), no active drug) given into the spinal fluid. During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo (aCSF) administered into the spinal fluid. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 days, 12 to 24 weeks apart. * The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks post Dose 2.
対象疾患
介入
依頼者(Sponsor)
実施施設 (3)
P-One Clinic, Keikokai Medical Corporation
Hachiōji, Tokyo, Japan(RECRUITING)
愛媛大学医学部附属病院
Tōon, Ehime, Japan(NOT_YET_RECRUITING)
大分大学医学部附属病院
Yufu, Oita Prefecture, Japan(NOT_YET_RECRUITING)