Clinical trial NCT02280434: Phase 1 Study Accessing the Safety and Tolerability of CBP-307
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autoimmune Diseases
Lead sponsor: Connect Biopharm LLC
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
name: Nucleus Network Ltd
First posted: 2014-10-31
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CBP-307 following oral single and multiple escalating dose administration in healthy subjects.

Detailed description: This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CBP-307 following oral single and multiple escalating dose administration in healthy subjects. The study will have two parts: Part 1 will assess 5 dose levels of the drug in single dosing; and Part 2 will evaluate 3 dose levels in 28-day repeat dosing. The effect of food will also be evaluated in a single dosing study.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Plasma Concentrations of Study Drug Over Time and Maximal Plasma Concentration (Cmax)
timeFrame: Up to 6 weeks
measure: Elimination Half-live (T1/2) of Study Drug
timeFrame: Up to 6 weeks
measure: Exposure to Study Drug Measured as Area Under the Curve (AUC)
timeFrame: Up to 6 weeks
measure: Effect of Study Drug on Blood Lymphocyte Counts
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
affiliation: Nucleus Network
name: Jason Lickliter, MD, PhD, FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Suzhou Connect Biopharmaceuticals
name: Zheng Wei, PhD
role: STUDY_DIRECTOR
References: