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

NCT01513967 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-03-23

Study results available
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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)

Conditions

  • Healthy Volunteers
  • Moderate to Severe Alzheimer Patients

Interventions

DRUG

RPh201, botanical drug product

SC administration at varying doses

DRUG

Placebo

SC administration at varying doses

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Regenera Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Janice Faulknor, MD · Kendle Early Stage - Toronto

  • Sharon Cohen, MD · Toronto Memory Program

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513967 on ClinicalTrials.gov