A Phase I Study to evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic profile of single and multiple dose of ANB019 in Healthy Subjects and Psoriasis Patients.
- Conditions
- Generalized Pustular PsoriasisPalmoplantar PustolosisPlaque PsoriasisInflammatory and Immune System - Autoimmune diseasesSkin - Dermatological conditions
- Registration Number
- ACTRN12617000369325
- Lead Sponsor
- AnaptysBio Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 87
For the healthy participants cohorts - healthy male and female as determined by a lack of clinically significant medical history, physical examination, ECGs, and clinical laboratory determinations.
For the plaques psoriasis cohort - male and female participants as determined by lack of clinically significant medical history other than clinically diagnosed moderate to severe plaque psoriasis.
1) Medical History and Concurrent Diseases:
a)Any significant acute or chronic medical illness.
b)Presence of any factors that would predispose the subject to develop infection e.g., rectal fissures, poor dentition, open skin lesions, and presence of pre-existing skin conditions that increase risks for injection site complications e.g. Behcet’s Disease, Psoriasis, pustular dermatoses.
c)Current or recent (within 3 months of study drug administration) gastrointestinal disease.
d)Previous administration of mAbs
2) Psoriasis Patients
a)Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug.
b)Have applied any topical medication (including corticosteroid, calcineurin inhibitor,topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation within 21 days prior to Day -1.
c)Have received antibiotic treatment within 1 week prior to study entry.
d)Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, non-steroidals, immunosuppressants, or immunomodulating drugs) or treatment with UV light.
e)Have received any investigational drug or been part of any clinical trial within a period of three months or five half-lives (whichever is longer) prior to study entry.
f)Previous treatment with anti-tumour necrosis factor (TNF)/interleukin (IL-12/IL-23) and IL-17 or any other monoclonal antibodies is not allowed within 3 months or 5 half-lives or twice the duration of the biological effect of the product prior to Day -1.
3) Physical and Laboratory Test Findings:
a)Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
4) Allergies and Adverse Drug Reaction
a)History of any significant drug allergy or reaction (such as anaphylaxis or hepatotoxicity) and reactivity to polysorbate 20 a component of ANB019 formulation, or the inactive ingredients (excipients)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessments of ANB019 administration will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests. The incidence of observed adverse events will be tabulated and reviewed for potential significance and clinical importance.[Adverse events will be assessed continuously from the time of the first administration of IMP through to discharge from the study at the follow-up visit. ECGs will be performed during screening, on Day -1, Days 8, 15, 22 and 85.]
- Secondary Outcome Measures
Name Time Method