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Trial details imported from ClinicalTrials.gov
Ethics application status
Ascending Dose Study of CT1812 in Healthy Volunteers
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
Universal Trial Number (UTN)
Other mental health disorders
Description of intervention(s) / exposure
Treatment: Drugs - CT1812
Treatment: Drugs - Placebo
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.
Placebo Comparator: Matching Placebo - In cohorts 1-6, 8 subjects will be enrolled. 6 subjects will receive matching placebo.
Treatment: Drugs: CT1812
Doses will be escalated in the following sequence: 10mg, 30mg, 90mg, 180mg, 360mg, 650mg.
Treatment: Drugs: Placebo
Matching placebo administered.
Intervention code 
Comparator / control treatment
Primary outcome 
Incidence and review of Treatment Emergent Adverse Events [Safety and Tolerability] - Treatment Emergent Adverse Events will be assessed by reviewing:
monitoring vital signs,
monitoring clinical and laboratory assessments,
Key inclusion criteria
- Willing and able to provide written informed consent prior to initiation of any
- 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.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- 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
- Evidence of active infection requiring antibiotic therapy within 14 days prior to
- 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
- History of head injury.
- Chronic kidney disease.
- Signs of dementia or cognitive impairment in the elder cohorts.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Nucleus Network Limited - Melbourne
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
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).
Trial related presentations / publications
Jason Lickliter, MD
Nucleus Network Ltd