A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects and Exploratory Efficacy of FPP003 Vaccine in Subjects with Psoriasis.

Phase 1

Completed

• Conditions: Psoriasis; Skin - Dermatological conditions

• Registration Number: ACTRN12619000599178
• Lead Sponsor: FunPep Co. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-17
• Study Completion: 2022-09-27
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Male or female aged 18 to 75 years (inclusive) at screening;
2. Body mass index (BMI) of greater than 18.5 kg/m2 and less than 38 kg/m2 at screening;
3. History of plaque-type psoriasis for greater than or equal to 6 months;
4. Plaque-type psoriasis based on PASI score greater than or equal to 5 at both the screening and baseline visits;

Exclusion Criteria

1. Presence of non-plaque psoriasis i.e., pustular, erythrodermic psoriasis;
2. Presence of other skin condition other than psoriasis, in particular eczema, skin infections or an inherited skin disorder (other than psoriasis) that would interfere with the ability to perform study assessments;
3. History or evidence of a clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator and medical monitor or designee, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;

Study & Design

• Study Type: Interventional
• Study Design: Not specified