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.
A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANB019 in Healthy Subjects and Psoriasis Patients.
AnaptysBio Pty Ltd
87 participants
Apr 3, 2017
Interventional
Conditions
Summary
This study will be conducted in three parts: the first part will investigate the effect of a single dose of ABN019 on healthy participants; the second part will investigate the effect of a single dose of ANB019 on psoriasis patients and the third part will investigate the effect of multiple (weekly) doses of ABN019 for 4 weeks on healthy participants. The single dose study will explore different doses of the study drug given either via a subcutaneous (under the skin) injection (SC) or via an intravenous (into the vein) infusion (IV). The results from this part will be used to determine the dose and route of administration to be used for the psoriasis patient part and the multiple dose part of the study. Over the entire study a total of 87 people will be enrolled over 10 dosing groups/ cohorts. In each group of 8 healthy participants, 6 will receive the active drug, ANB019 and the other 2 will receive an equivalent placebo (an injection/ infusion that looks identical to the active drug, but contains no active drug). In the psoriasis patient group, out of the 15 patients, 10 will receive the active drug, ANB019, and the remaining 5 will receive placebo. This study is a dose escalation study meaning that the first group/ cohort will receive the lowest dose of study drug. Results will be reviewed by a safety monitoring committee after each dose strength has been tested to make sure that it is safe to continue with the next higher dose strength in the next group. The next group will not be enrolled until the safety monitoring committee have confirmed it is safe to do so. The study can be stopped at any time, based on evaluation of the side effects of the study drug. As this is a first in human study, the primary objective of the study is to assess the safety and tolerability of single and multiple doses of ANB019 administered to healthy humans.
Eligibility
Inclusion Criteria2
- 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.
Exclusion Criteria16
- 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
- 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.
- 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.
- 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)
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Interventions
This is a first-in human study of ANB019. It is a double-blind, randomized, placebo controlled, ascending single (SAD) and multiple-doses (MAD) study in healthy participants with one single dose plaque psoriasis patient cohort. The study is planned to have approximately seven cohorts in the SAD section (six for the healthy participants and one for the plaque psoriasis patients) and approximately three in the MAD section of the study (healthy participants only). Eight (8) healthy participants will be assigned to all single and multiple dose healthy participants cohorts at predicted doses ranging from 10mg to 750mg. 15 plaque psoriasis patients will be assigned to a single dose cohort. The study drug will be administered by subcutaneous (SC) or intravenous (IV) infusion. For the MAD part and the plaque psoriasis patient cohort, the doses and administration method (SC or IV) will be determined based on the results from the healthy participant SAD part.. Participants in the single dose cohorts will be admitted to the clinical facility on Day -1 and will remain in the clinic for up to 3 days for a total of up to 4 days in-house. Dosing of ANB019 or placebo will occur on Day 1. Safety PK and PD assessments will be performed during the study. Participants in the multiple-dose cohort(s) will be admitted to the clinical facility on Day-1 and will remain in the clinic for 3 days for a total of 4 days in-house. Following this in-house period, participants will be admitted the evening prior to their next dosing day and discharged the evening of the day of dosing for a total of 3 additional doses of ANB019 and 3 additional days in-house for a total of 7 days.
Locations(1)
View Full Details on ANZCTR
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ACTRN12617000369325