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A Study to Investigate the Safety and Tolerability of CAN10 Antibody in Healthy Subjects and in Subjects With Plaque Psoriasis. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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.

NCT06143371•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•History or presence of:
•1. Severe allergy/hypersensitivity (subjects with mild pollen allergy can be included).
•2. Significant kidney, liver, or urologic disease.
•3. Clinically significant psychiatric disorders
•4. Tuberculosis (TB) infection or positive QuantiFERON TB Gold test
•5. 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.
•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:
+8 more criteria

Locations (1)

CRS Clinical Research Services Berlin GmbH

Berlin, Germany

Key Dates

Start Date

August 21, 2023

Primary Completion Date

November 10, 2025

Completion Date

November 10, 2025

Last Updated

February 5, 2026

Enrollment

ACTUAL participants

Conditions

HealthyPlaque Psoriasis

Interventions

CAN10

BIOLOGICAL

CAN10 - Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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