Phase 1 Study Accessing the Safety and Tolerability of CBP-307

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

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

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases
• Intervention / Treatment: Drug: Placebo; Drug: CBP-307

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBP-307; Participants will receive a single dose or once daily dose of CBP-307 for 28 days.	Drug: CBP-307
Placebo Comparator: Placebo; Participants will receive a single dose or once daily dose of matching placebo for 28 days.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Safety measurements will include vital signs, hematology, blood chemistry, blood pressure and other readouts.	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma Concentrations of Study Drug Over Time and Maximal Plasma Concentration (Cmax)	Up to 6 weeks
Elimination Half-live (T1/2) of Study Drug	Up to 6 weeks
Exposure to Study Drug Measured as Area Under the Curve (AUC)	Up to 6 weeks
Effect of Study Drug on Blood Lymphocyte Counts	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
• Collaborators: Tigermed Consulting Co., Ltd; Nucleus Network Ltd
• Investigators: Principal Investigator: Jason Lickliter, MD, PhD, FRACP, Nucleus Network; Study Director: Zheng Wei, PhD, Suzhou Connect Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 29, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: CBP-307AU001