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.
• 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.