Ascending Dose Study of CT1812 in Healthy Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|