Ascending Dose Study of CT1812 in Healthy Volunteers
This study has been completed.
Information provided by (Responsible Party):
First received: September 28, 2015
Last updated: September 5, 2016
Last verified: October 2015
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).
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
||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
Primary Outcome Measures:
- 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.
| Study Start Date:
| Primary Completion Date:
||May 2016 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 75 Years (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Willing and able to provide written informed consent prior to initiation of any study-related procedures.
- Men and women either ≥ 18 and ≤ 55 years of age or ≥ 65 and ≤75 years of age, depending on cohort.
- In good health as determined by medical history, physical exam, laboratory examinations, ECG, and vital signs.
- BMI between 19 and 34 kg/m2, inclusive.
- Weight between 50 and 100 kg, inclusive.
- ECG without clinically significant pathologic abnormalities and with QTcB <450.
- Normotensive as defined by systolic BP ≤ 150 mmHg and diastolic BP ≤ 90 mmHg.
- No suicidal ideation, as demonstrated by a score of "0" on the Columbia Suicide Severity Rating Scale (C-SSRS). Part B Only.
- Women who are neither pregnant (negative pregnancy test) nor nursing, and are either surgically sterile or postmenopausal.
- Any chronic medical condition (such as type 1 diabetes) requiring chronic treatment that might increase the risk to the subject or confound interpretation of safety observations.
- Evidence of active infection requiring antibiotic therapy within 14 days prior to screening.
- Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis.
- History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin.
- Seropositive for human immunodeficiency virus (HIV).
- History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for Hepatitis B surface antigen [HbsAg] or anti-Hepatitis C [HCV] antibody).
- Clinically significant abnormalities in specified screening laboratory tests
- All prescription, over-the-counter and herbal medications are prohibited within 10 days prior to study dosing (with exception of calcium/vitamin D supplements, nasal steroids, ocular medications, and paracetamol at the discretion of the Investigator).
- Use of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing in this study.
- Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs.
- Psychiatric history of current or past psychosis, bi-polar disorder, clinical depression, or anxiety disorder requiring chronic medication within the past 5 years.
- History of substance abuse.
- History of substance or drug dependence or positive urine drug screen at screening visit.
- History of head injury.
- Chronic kidney disease.
- Signs of dementia or cognitive impairment in the elder cohorts.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02570997
|Nucleus Network Limited
|Melbourne, Victoria, Australia, 3004 |
||Jason Lickliter, MD
||Nucleus Network Ltd
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 28, 2015
||September 5, 2016
Keywords provided by Cognition Therapeutics:
Mild Cognitive Impairment
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 19, 2017