Ascending Dose Study of CT1812 in Healthy Volunteers

NCT02570997 | Completed Phase 1 DMC

• 1 other identifier: Cog 0101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Cognitive Impairment

Keywords

Alzheimer's Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Incidence and review of Treatment Emergent Adverse Events [Safety and Tolerability]

  Treatment Emergent Adverse Events will be assessed by reviewing: * physical examinations, * monitoring vital signs, * monitoring clinical and laboratory assessments, * monitoring ECGs.

  up to 35 days

Study Arms (2)

CT1812

ACTIVE COMPARATOR

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.

Drug: CT1812

Matching Placebo

PLACEBO COMPARATOR

In cohorts 1-6, 8 subjects will be enrolled. 6 subjects will receive matching placebo.

Drug: Placebo

Interventions

CT1812 DRUG

Doses will be escalated in the following sequence: 10mg, 30mg, 90mg, 180mg, 360mg, 650mg.

Also known as: Study drug

CT1812

Placebo DRUG

Matching placebo administered.

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Non-smokers.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cognition Therapeutics: lead

Study Sites (1)

Nucleus Network Limited

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Jason Lickliter, MD

  Nucleus Network Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 8, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2015-10

Locations

AU (1)