Conditions: Healthy Volunteers Moderate to Severe Alzheimer Patients
Keywords: Alzheimer, dementia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: yes

Brief 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)

Detailed description:
The primary objective of this study is to evaluate the safety and tolerability of RPh201 after single and multiple ascending doses. This study is designed with sufficient time in between dose escalations to allow for an interim analysis of safety and tolerability data as this is considered the safest approach to assess the effects of a compound with an undefined mechanism and therapeutic target.

This protocol is written with some flexibility to accommodate the inherent dynamic nature of Phase I clinical studies. Modifications to the dose, dosing regimen, and/or clinical or laboratory procedures currently outlined below may be required to achieve the scientific goals of the study objectives and/or to ensure appropriate safety monitoring of the study subjects. Interim safety analyses will guide dose escalation/reduction in the trial.

Arms:
arm 1: RPh201 single dose (SAD Low Dose ) arm 2: Placebo single dose (SAD Low Dose ) arm 3: RPh201 single dose (SAD Mid Dose ) arm 4: Placebo single dose (SAD Mid Dose ) arm 5: RPh201 single dose (SAD High Dose ) arm 6: Placebo single dose (SAD High Dose ) arm 7: RPh201 multiple dose (MAD Low Dose ) arm 8: Placebo multiple dose (MAD Low Dose ) arm 9: RPh201 multiple dose (MAD Mid Dose ) arm 10: Placebo multiple dose (MAD Mid Dose ) arm 11: RPh201 multiple dose (MAD High Dose ) arm 12: Placebo multiple dose (MAD High Dose )

Interventions: intervention 1: RPh201, botanical drug product intervention 2: Placebo
Intervention descriptions: intervention 1: SC administration at varying doses intervention 2: SC administration at varying doses

Protocol document: