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Autoimmune DiseasesPhase 1NCT02280434

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

A Phase 1 study testing CBP-307 in people with Autoimmune Diseases, run by Connect Biopharm LLC at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Autoimmune Diseases
What is being tested?
CBP-307
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteAustralia
Study dates
Nov 2014to Aug 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus Network

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

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

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

Read the 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.

Being tested
CBP-307, Placebo
Medical subject headings
Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBP-307Drug

  • PlaceboDrug

Study groups in NCT02280434
Study groupRoleWhat they receive
CBP-307Active comparatorParticipants will receive a single dose or once daily dose of CBP-307 for 28 days.
Receives: Drug: CBP-307
PlaceboPlacebo comparatorParticipants will receive a single dose or once daily dose of matching placebo for 28 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 6 weeks

Secondary outcomes (4)

  1. Plasma Concentrations of Study Drug Over Time and Maximal Plasma Concentration (Cmax)

    Measured: Up to 6 weeks

  2. Elimination Half-live (T1/2) of Study Drug

    Measured: Up to 6 weeks

  3. Exposure to Study Drug Measured as Area Under the Curve (AUC)

    Measured: Up to 6 weeks

  4. Effect of Study Drug on Blood Lymphocyte Counts

    Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02280434
Sponsor's protocol ID
CBP-307AU001
Status last verified
Nov 2016
First submitted
20 Oct 2014
Last updated
3 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38953034

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CBP-307 in people with Autoimmune Diseases, run by Connect Biopharm LLC at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02280434, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.

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