Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02280434




Registration number
NCT02280434
Ethics application status
Date submitted
20/10/2014
Date registered
31/10/2014
Date last updated
3/11/2016

Titles & IDs
Public title
Phase 1 Study Accessing the Safety and Tolerability of CBP-307
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CBP-307 Following Oral Single and Multiple Escalating Dose Administration
Secondary ID [1] 0 0
CBP-307AU001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune Diseases 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: CBP-307 - Participants will receive a single dose or once daily dose of CBP-307 for 28 days.

Placebo comparator: Placebo - Participants will receive a single dose or once daily dose of matching placebo for 28 days.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timepoint [1] 0 0
up to 6 weeks
Secondary outcome [1] 0 0
Plasma Concentrations of Study Drug Over Time and Maximal Plasma Concentration (Cmax)
Timepoint [1] 0 0
Up to 6 weeks
Secondary outcome [2] 0 0
Elimination Half-live (T1/2) of Study Drug
Timepoint [2] 0 0
Up to 6 weeks
Secondary outcome [3] 0 0
Exposure to Study Drug Measured as Area Under the Curve (AUC)
Timepoint [3] 0 0
Up to 6 weeks
Secondary outcome [4] 0 0
Effect of Study Drug on Blood Lymphocyte Counts
Timepoint [4] 0 0
Up to 6 weeks

Eligibility
Key inclusion criteria
* Informed consent must be obtained in writing for all subjects at enrollment into the study
* Healthy male subjects age between 18 and 55 years, inclusive
* Body mass index (BMI) between 19 and 30 kg/m2, inclusive
* No clinically significant findings in the medical history and physical examination, especially with regard to the liver and gastrointestinal systems
* No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant
* Normal ECG, blood pressure, and heart rate, unless the investigator considers any abnormality to be clinically irrelevant
* Resting heart rate = 55 bpm
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Family history of premature CHD (Coronary Heart Disease)
* Any condition requiring the regular use of any medication
* Exposure to prescription medications or to drugs known to interfere with metabolism of drugs within 30 days prior to screening
* Exposure to any other medication, including over-the counter medications, herbal remedies and vitamins 14 days prior to randomization (except paracetamol (see Section 5.2 Prior and concomitant treatments)
* Participation in another study with any investigational drug in the 2 months preceding the study
* Treatment in the previous 3 months with any drug known to have a well defined potential for toxicity to a major organ
* Positive urine cotinine result at screening
* Be in the exclusion period of any previous study with investigational drugs
* Symptoms of a clinically significant illness in the 3 months before the study
* Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
* Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease
* Hemorrhoids or anal diseases with regular or recent presence of blood in feces
* History of significant allergic disease (e.g. medications) and acute phase of allergic rhinitis in the previous 2 weeks before randomization or any food allergy
* Blood or plasma donation of more than 500 ml during the previous 2 month before randomization and/or more than 50 ml in the 2 weeks prior to screening
* Subjects at risk for tuberculosis (TB), specifically subjects with: Current clinical, radiographic or laboratory evidence of active TB; history of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type;latent TB which has not been successfully treated; a positive quantiFERON® test at screening or within 6 months prior to Day 1
* Known positive test for HIV
* Known positive test for hepatitis B (antigens HBs, antibody HBc) or C, unless caused by immunization
* History of shingles or recurrent episodes of HSV1 or HSV2 infections
* Current evidence of drug abuse or history of drug abuse within one year before randomization
* History of alcohol abuse or active alcoholism as defined in Appendix A Definition of alcohol abuse
* Mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study
* Adults under guardianship and people with restriction of freedom by administrative or legal decisions
* Unlikely to comply with the clinical study protocol; e.g. uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
* Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
* Systolic blood pressure less than 95 mmHg or greater than 140 mmHg, or diastolic blood pressure less than or equal to 50 mmHg or greater than or equal to 95 mmHg.
* Subjects with resting heart rate less than 55 beats per minute or greater than 90 beats per minute.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Suzhou Connect Biopharmaceuticals, Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Tigermed Consulting Co., Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Nucleus Network Ltd
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MD, PhD, FRACP
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02280434