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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06143371
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Cantargia AB
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Manuela Casjens, MD
Principal Investigator Affiliation CRS Clinical Research Services Berlin GmbH
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Healthy, Plaque Psoriasis
Arms & Interventions

Arms

Experimental: CAN10 single ascending dose

A single dose of CAN10 will be administered intravenously (IV) to healthy subjects.

Placebo Comparator: CAN10 single ascending dose - placebo

A single dose of matching placebo will be administered intravenously (IV) to healthy subjects.

Experimental: CAN10 multiple ascending dose

Multiple doses of CAN10 will be administered subcutaneously (SC) to subjects with mild to moderate plaque psoriasis

Placebo Comparator: CAN10 multiple ascending dose - placebo

Multiple doses of matching placebo will be administered subcutaneously (SC) to subjects with mild to moderate plaque psoriasis

Interventions

Biological: - CAN10

Single dose intravenous or Multiple doses subcutaneously

Biological: - CAN10 - Placebo

Single dose intravenous or Multiple doses subcutaneously

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Berlin, Germany

Status

Recruiting

Address

CRS Clinical Research Services Berlin GmbH

Berlin, , 13627

Site Contact

Manuela Casjens, MD

Manuela.Casjens@crs-group.de

+46 46 2756260

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