Psoriasis
Conditions
Interventions
The volunteer receives 200 mg of tildrakizumab twice. Tildrakizumab is given
once as 1 injection and once as 2 injections. The test substance will be
administered under the skin (subcutaneously) in
Sponsors
Almirall
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men or women must be between 18 and 60 years, inclusive, at screening. 2. Body mass index (BMI) must be between 18.0 and 30.0 kg/m2, inclusive, at screening. 3. Subjects must be able to understand and comply with the requirements of the study and communicate with the Investigator. 4. Subjects must give a written, signed, and dated informed consent including authorization for Use and Release of Health and Research Information in accordance with institutional and regulatory guidelines before any study-related activity is performed. 5. Subjects are in good general health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator. For the complete overview see the protocol
Exclusion criteria
Exclusion criteria: 1. Any condition that could interfere with delivery of medication or interpretation of assessments or significantly impair pain perception at any of the anatomical sites for injection (upper arms, thighs, abdomen). 2. History of or current malignancy (excluding successfully treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma with no evidence of recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated). 3. History of or current relevant autoimmune diseases (e.g., lupus-like syndromes). 4. Clinically significant skin allergies or active dermatologic disorders. 5. Hypersensitivity to the active substance or to any of the excipients of the investigational medicinal product (IMP). For the complete overview see the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the local tolerability of the tildrakizumab 200-mg dose when administered as a single 200 mg/2 mL SC injection or as two 100 mg/1 mL SC injections in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of the tildrakizumab 200-mg dose when administered as a single 200 mg/2 mL SC injection or as two 100 mg/1 mL SC injections in healthy subjects. To assess the subjects* preferred method of administration of the tildrakizumab 200-mg treatments (single 2 mL or two 1 mL injections). | — |
Countries
Netherlands
Outcome results
None listed