A Phase 1, Open-label, Single-dose, Randomized, Crossover Study to Assess the Local Tolerability of the Tildrakizumab 200 mg Dose when Delivered as Single Subcutaneous Injection via the 200 mg/2 mL Pre-filled Syringe

Completed

Conditions: Psoriasis
10014982

Registration Number: NL-OMON49835

Lead Sponsor: Almirall

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 42

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the local tolerability of the tildrakizumab 200-mg dose when<br /><br>administered as a single 200 mg/2 mL SC injection or as two 100 mg/1 mL SC<br /><br>injections in healthy subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the safety of the tildrakizumab 200-mg dose when administered as a<br /><br>single 200 mg/2 mL SC injection or as two 100 mg/1 mL SC injections in healthy<br /><br>subjects.<br /><br><br /><br>To assess the subjects* preferred method of administration of the tildrakizumab<br /><br>200-mg treatments (single 2 mL or two 1 mL injections).</p><br>