Ascending Dose Study of CT1812 in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT02570997|
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment||Drug: CT1812 Drug: Placebo||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Two-Part, Double-Blind, Placebo-Controlled, Phase I Study of the Safety Pharmacokinetics of Single and Multiple Ascending Doses of CT1812 in Healthy Volunteers|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 2016|
Active Comparator: CT1812
In cohorts 1-6, 8 subjects will be enrolled. 6 subjects will receive CT1812. Doses will be escalated in the following sequence: 10mg, 30mg, 90mg, 180mg, 360mg, 650mg.
Should an MTD not be identified, additional cohorts at higher doses may be enrolled. The maximum dose administered will not exceed 1350mg.
Doses will be escalated in the following sequence: 10mg, 30mg, 90mg, 180mg, 360mg, 650mg.
Other Name: Study drug
Placebo Comparator: Matching Placebo
In cohorts 1-6, 8 subjects will be enrolled. 6 subjects will receive matching placebo.
Matching placebo administered.
- Incidence and review of Treatment Emergent Adverse Events [Safety and Tolerability] [ Time Frame: up to 35 days ]
Treatment Emergent Adverse Events will be assessed by reviewing:
- physical examinations,
- monitoring vital signs,
- monitoring clinical and laboratory assessments,
- monitoring ECGs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570997
|Nucleus Network Limited|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Jason Lickliter, MD||Nucleus Network Ltd|