AzTrials
AzTrials

HealthyPhase 1NCT06143371

A Study to Investigate the Safety and Tolerability of CAN10 Antibody in Healthy Subjects and in Subjects With Plaque Psoriasis.

A Phase 1 study testing CAN10 in people with Healthy and Plaque Psoriasis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Germany.

Completed

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

Official record
Search all trials

Trial summary

This is a first-in-human, randomized, double- blind, placebo-controlled, dose escalation study to investigate how different doses of CAN10 are tolerated, taken up by the body and how long CAN10 stays in the body. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Plaque Psoriasis
What is being tested?
CAN10
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteGermany
Study dates
21 Aug 2023to 10 Nov 2025
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female, aged 18 to 50 years of age (inclusive) at the time of signing informed consent.
  • Body mass index (BMI) 18 to 30 kg/m2 (inclusive) and a weight between 50 to 100 kg (inclusive) at the time of screening
  • Considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
  • Female subjects of childbearing potential must use a highly effective method of birth control and have a negative pregnancy test at screening and before the first dose of study drug. Male subjects with female partners must agree to use a condom, and their female partners are recommended to use a highly effective method of birth control.
  • Additionally for subjects with plaque psoriasis only:
  • A diagnosis of plaque psoriasis with Psoriasis Area Severity Index (PASI) score ≥3 to ≤15 and Physician Global Assessment (PGA) score ≥2 (mild) to <4 (moderate).
  • No disease manifestation requiring systemic immunosuppressive therapy.

Who cannot join

  • History or presence of:
  • Severe allergy/hypersensitivity (subjects with mild pollen allergy can be included).
  • Significant kidney, liver, or urologic disease.
  • Clinically significant psychiatric disorders
  • Tuberculosis (TB) infection or positive QuantiFERON TB Gold test
  • Any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
Show all 18Show fewer
  • Clinically significant illness, medical/surgical procedure, or trauma within 4 weeks before the first dose of study drug.
  • Ongoing opportunistic or systemic infections
  • A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antigen or antibodies at screening.
  • Additionally for subjects with plaque psoriasis only:
  • Psoriasis other than a plaque variant.
  • Any sign of infection of any of the psoriatic lesions.
  • Use of any of the following treatments within the indicated washout period before the first dose of study drug:
  • 12 weeks or 5 half-lives (whichever is longer) for biologic agents known or expected to impact the course of psoriasis or its assessments.
  • 12 weeks for oral retinoids
  • 8 weeks for cyclosporin, interferon, methotrexate, other systemic immunosuppressive or immunomodulating agents, or psoralen plus ultraviolet A (UVA)
  • 2 weeks for immunizations or drugs known to possibly worsen psoriasis, unless on a stable dose for >12 weeks
  • 1 week for topical treatments: corticosteroids, immunomodulators, anthralin (dithranol), Vitamin D derivatives, retinoids, or coal tar (used on the body)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • CRS Clinical Research Services Berlin GmbH

    Berlin, 13627

Other trials in Germany

About this study

Official title: A Phase I (First-in-human) Randomized, Double-blind, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CAN10, an Anti-IL1RAP Monoclonal Antibody, in Healthy Subjects and in Subjects With Mild to Moderate Plaque Psoriasis.

This is a first-in-human, randomized, double- blind, placebo-controlled, dose escalation study to investigate how different doses of CAN10 are tolerated, taken up by the body and how long CAN10 stays in the body. In the first part of the study, the single ascending dose (SAD) cohorts, CAN10 will be given as a single intravenous dose to healthy subjects. In the second part of the study, the multiple ascending dose (MAD) cohorts, CAN10 will be given as repeated subcutaneous doses to participants with mild to moderate plaque psoriasis.

Being tested
CAN10, CAN10 - Placebo

What participants receive

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

  • CAN10Biological

    Single dose intravenous or Multiple doses subcutaneously

  • CAN10 - PlaceboBiological

    Single dose intravenous or Multiple doses subcutaneously

Study groups in NCT06143371
Study groupRoleWhat they receive
CAN10 single ascending doseExperimentalA single dose of CAN10 will be administered intravenously (IV) to healthy subjects.
Receives: Biological: CAN10
CAN10 single ascending dose - placeboPlacebo comparatorA single dose of matching placebo will be administered intravenously (IV) to healthy subjects.
Receives: Biological: CAN10 - Placebo
CAN10 multiple ascending doseExperimentalMultiple doses of CAN10 will be administered subcutaneously (SC) to subjects with mild to moderate plaque psoriasis
Receives: Biological: CAN10
CAN10 multiple ascending dose - placeboPlacebo comparatorMultiple doses of matching placebo will be administered subcutaneously (SC) to subjects with mild to moderate plaque psoriasis
Receives: Biological: CAN10 - Placebo

What is being measured

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

  1. To investigate the safety and tolerability of single and multiple ascending doses of CAN10

    Frequency, seriousness, and intensity of treatment-emergent adverse events (TEAEs) in subjects receiving single and multiple doses of CAN10

    Measured: From the day of the first dose until day 57 after the last dose

Secondary outcomes (11)

  1. Assessment of Area under plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) after single (IV) dosing

    Measured: From the day of dosing (day 1) until day 57 after dosing

  2. Assessment of AUC from time zero to last measurable serum concentration (AUClast) following single (IV) and multiple (SC) dosing

    Measured: From the day of the first dose until day 57 after the last dose

  3. Assessment of AUC from time 0 to 336 hours post dose (i.e., AUC over a 2-week interval) after multiple (SC) dosing on Day 36 (AUC0-336,MD)

    Measured: From the last dose until 336 hours after the last dose

  4. Assessment of the maximum observed concentration (Cmax) following single (IV) and multiple (SC) dosing

    Measured: From the day of the first dose until day 57 after the last dose

  5. Assessment of time to maximum observed serum concentration (Tmax) following single (IV) and multiple (SC) dosing

    Measured: From the day of the first dose until day 57 after the last dose

  6. Assessment of the terminal elimination rate constant (λz) following single (IV) and multiple (SC) dosing

    Measured: From the day of the first dose until day 57 after the last dose

  7. Assessment of the terminal halflife (t1/2) following single (IV) and multiple (SC) dosing

    Measured: From the day of the first dose until day 57 after the last dose

  8. Assessment of the total clearance (CL) following single (IV) dosing)

    Measured: From the day of dosing (day 1) until day 57 after dosing

  9. Assessment of the volume of distribution (Vd) following single (IV) dosing

    Measured: From the day of dosing (day 1) until day 57 after dosing

  10. Assessment of total clearance following extravascular administration (CL/F) following multiple (SC) dosing

    Measured: From the day of the first dose until day 57 after the last dose

  11. Assessment of volume of distribution following extravascular administration (Vd/F) following multiple (SC) dosing

    Measured: From the day of the first dose until day 57 after the last dose

Timeline

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

  1. First posted22 Nov 2023
  2. Study start21 Aug 2023
  3. Primary completion10 Nov 2025
  4. Study completion10 Nov 2025

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06143371
Sponsor's protocol ID
CAN10CLIN001
Other IDs
2023-504450-35, 2023
Status last verified
Feb 2026
First submitted
16 Nov 2023
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mulholland M, Depuydt MAC, Jakobsson G, Ljungcrantz I, Grentzmann A, To F, Bengtsson E, Jaensson Gyllenback E, Gronberg C, Rattik S, Liberg D, Schiopu A, Bjorkbacka H, Kuiper J, Bot I, Slutter B, Engelbertsen D. Interleukin-1 receptor accessory protein blockade limits the development of atherosclerosis and reduces plaque inflammation. Cardiovasc Res. 2024 May 7;120(6):581-595. doi: 10.1093/cvr/cvae046.

    PubMed 38563353

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAN10 in people with Healthy and Plaque Psoriasis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Germany.

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 18 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 5 Feb 2026. 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 Germany. 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?

To investigate the safety and tolerability of single and multiple ascending doses of CAN10 (time frame: From the day of the first dose until day 57 after the last dose). 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 NCT06143371, 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 5 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in