Ascending Dose Study of CT1812 in Healthy Volunteers
NCT02570997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2016-09-07
Summary
This is a double-blind, placebo controlled, ascending dose, multi-cohort trial. The study will be conducted in two phases: a single ascending dose (SAD) phase "Part A", followed by a multiple ascending dose (MAD) phase "Part B". In Part A, subjects will receive one dose of study drug. In Part B, subjects within a cohort will receive the same dose daily for 14 days. In both parts, sequential cohorts will be exposed to increasing doses of CT1812 in order to identify the maximum tolerated dose (MTD).
Conditions
Interventions
- DRUG
-
CT1812
Doses will be escalated in the following sequence: 10mg, 30mg, 90mg, 180mg, 360mg, 650mg.
- DRUG
-
Matching placebo administered.
Sponsors & Collaborators
-
Cognition Therapeutics
lead INDUSTRY
Principal Investigators
-
Jason Lickliter, MD · Nucleus Network Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2016-05-31
Countries
- Australia
Study Locations
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