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

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

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 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:
  1. Severe allergy/hypersensitivity (subjects with mild pollen allergy can beincluded).
  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 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:
  1. 12 weeks or 5 half-lives (whichever is longer) for biologic agents known orexpected to impact the course of psoriasis or its assessments.
  2. 12 weeks for oral retinoids
  3. 8 weeks for cyclosporin, interferon, methotrexate, other systemicimmunosuppressive or immunomodulating agents, or psoralen plus ultraviolet A (UVA)
  4. 2 weeks for immunizations or drugs known to possibly worsen psoriasis, unless ona 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)

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
    Germany

    Active - Recruiting

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