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

NCT02280434 | Completed Phase 1

• 1 other identifier: CBP-307AU001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

CBP-307

ACTIVE COMPARATOR

Participants will receive a single dose or once daily dose of CBP-307 for 28 days.

Drug: CBP-307

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose or once daily dose of matching placebo for 28 days.

Drug: Placebo

Interventions

CBP-307 DRUG

CBP-307

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Connect Biopharm LLC: lead
• Tigermed Consulting Co., Ltd: collaborator
• Nucleus Network Ltd: collaborator

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• Lickliter J, Yang X, Guo J, Pan W, Wei Z. Icanbelimod (CBP-307), a next-generation Sphingosine-1-phosphate receptor modulator, in healthy men: pharmacokinetics, pharmacodynamics, safety, and tolerability in a randomized trial in Australia. Front Immunol. 2024 Jun 17;15:1380975. doi: 10.3389/fimmu.2024.1380975. eCollection 2024.

  PMID: 38953034 DERIVED

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jason Lickliter, MD, PhD, FRACP

  Nucleus Network

  PRINCIPAL INVESTIGATOR

• Zheng Wei, PhD

  Suzhou Connect Biopharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 31, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

AU (1)