Last updated: November 28, 2023
Sponsor: Cantargia AB
Overall Status: Active - Recruiting
Phase
1
Condition
Skin Wounds
Warts
Psoriasis And Psoriatic Disorders
Treatment
CAN10
CAN10 - Placebo
Clinical Study ID
NCT06143371
CAN10CLIN001
2023-504450-35
Ages 18-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female, aged 18 to 50 years of age (inclusive) at the time of signing informedconsent.
- 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 medicalhistory, clinical laboratory test results, vital sign measurements, 12-lead ECGresults, and physical examination findings at screening.
- Female subjects of childbearing potential must use a highly effective method of birthcontrol and have a negative pregnancy test at screening and before the first dose ofstudy drug. Male subjects with female partners must agree to use a condom, and theirfemale 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
Exclusion Criteria:
- History or presence of:
- Severe allergy/hypersensitivity (subjects with mild pollen allergy can beincluded).
- 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 theinvestigator, may either put the subject at risk because of participation in thestudy, or influence the results or the subject's ability to participate in thestudy.
- Clinically significant illness, medical/surgical procedure, or trauma within 4 weeksbefore the first dose of study drug.
- Ongoing opportunistic or systemic infections
- A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, orhuman 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 thefirst dose of study drug:
- 12 weeks or 5 half-lives (whichever is longer) for biologic agents known orexpected to impact the course of psoriasis or its assessments.
- 12 weeks for oral retinoids
- 8 weeks for cyclosporin, interferon, methotrexate, other systemicimmunosuppressive or immunomodulating agents, or psoralen plus ultraviolet A (UVA)
- 2 weeks for immunizations or drugs known to possibly worsen psoriasis, unless ona 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)
Study Design
Total Participants: 80
Treatment Group(s): 2
Primary Treatment: CAN10
Phase: 1
Study Start date:
August 21, 2023
Estimated Completion Date:
April 24, 2025
Connect with a study center
CRS Clinical Research Services Berlin GmbH
Berlin, 13627
GermanyActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.