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

Launched by CANTARGIA AB · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called CAN10 to see how safe it is and how well it is tolerated by people. The study involves two groups: one group of healthy volunteers will receive a single dose of CAN10 through an intravenous (IV) line, while the other group will consist of participants with mild to moderate plaque psoriasis who will receive multiple doses of CAN10 through injections under the skin. The trial aims to understand how the body absorbs CAN10, how long it stays in the system, and to monitor any potential side effects.

To participate, individuals must be between 18 and 50 years old and generally healthy, with a specific body weight and height range. For those with plaque psoriasis, they should have a mild to moderate form of the condition. Participants will need to follow certain guidelines regarding other medications and health conditions. Throughout the trial, participants will be closely monitored for their health and any reactions to the treatment. This study is an important step in developing new options for managing psoriasis and could potentially help many patients in the future.

Gender

ALL

Eligibility criteria

• 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:
• • 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:
• • 1. 12 weeks or 5 half-lives (whichever is longer) for biologic agents known or expected to impact the course of psoriasis or its assessments.
• • 2. 12 weeks for oral retinoids
• • 3. 8 weeks for cyclosporin, interferon, methotrexate, other systemic immunosuppressive or immunomodulating agents, or psoralen plus ultraviolet A (UVA)
• • 4. 2 weeks for immunizations or drugs known to possibly worsen psoriasis, unless on a stable dose for \>12 weeks
• • 5. 1 week for topical treatments: corticosteroids, immunomodulators, anthralin (dithranol), Vitamin D derivatives, retinoids, or coal tar (used on the body)