A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB9741 administered by intravenous infusion or subcutaneous injection to healthy study participants and following repeat dosing at a single dose level in study participants with atopic dermatitis. Furthermore, the clinical outcome in study participants with atopic dermatitis after administration of UCB9741 by intravenous infusion will be investigated.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Biopharma SRL

Criteria

Inclusion Criteria:

Part A:

• Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)

• Participant must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring

• Participant has a body mass index (BMI) within the range 18 to 30 kg/m^2 (inclusive)

• Participant can be male or female

• A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the final dose of investigational medicinal product (IMP), and refrain from donating sperm during this period

• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days after the final dose of IMP

Part B:

• Participant must be 18 to 65 years of age inclusive at the time of signing the ICF

• Participant has been diagnosed with atopic dermatitis (AtD) according to American Academy of Dermatology criteria (2014), whose diagnosis was made at least 12 months prior to initiating the study (signing of the ICF), with an Eczema Area and Severity Index (EASI score) of ≥14 at Screening and ≥16 at Baseline

• Participant has a body mass index (BMI) within the range 18 to 30 kg/m^2 (inclusive)

• Participant can be male or female

• A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the final dose of IMP, and refrain from donating sperm during this period

• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days after the final dose of IMP

Exclusion Criteria:

Part A:

• Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or other biologic drugs as stated in this protocol

• Participant has a significant allergy to humanized monoclonal antibodies (mAbs)

• Participant has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions

• Participant has abnormal blood pressure (BP; outside the normal range) in a supine position after 5 minutes rest

• Participant has a recent history or currently active clinically-significant bacterial, fungal, endoparasite, or viral (including hospitalization for coronavirus disease 2019 (COVID-19)) infection (within 6 months of the Screening Visit)

• Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)

• Participant has a history of diabetes

• Participant has a corrected QT interval (QTc) >450 msec

• Participant has received any prescription or nonprescription medicines, including over the counter remedies and herbal and dietary supplements (other than vitamins within recommended daily dose limits), within 14 days (or 5 half-lives of the respective drug, whichever is longer) prior to the Baseline Visit, other than occasional use of analgesics, such as paracetamol (acetaminophen, with or without caffeine, with a maximal dose of 4 g/day and 10 g/14 days)

• Participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or within 90 days after the final dose of IMP

• Participant has been treated with biologic agents (such as mAbs, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the Baseline Visit

• Participant has participated in another study of an IMP within the previous 90 days or 5 half-lives of the IMP (whichever longer), or is currently participating in another study of an IMP

• Participant has sensitivity to heparin or heparin-induced thrombocytopenia

Part B:

• Participant has a known hypersensitivity to any components of the IMP or other biologic drugs as stated in this protocol

• Participant has significant allergies to humanized mAbs

• Participant has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)

• Participant has abnormal BP (outside the normal range) in a supine position after 5 minutes rest (systolic BP: 90 mmHg to 140 mmHg; diastolic BP: 50 mmHg to 90 mmHg; pulse rate: 40 bpm to 100 bpm). Any values marginally (eg, ≤5 mmHg) outside the normal range but considered not clinically significant by the investigator will be allowed. For values outside the permitted ranges, retesting is allowed at the discretion of the investigator. If the repeat readings are outside the normal range, the study participant will not be included in the study

• Participant has a recent history of or clinically active clinically-significant bacterial, fungal, endoparasite, or viral (or any history of hospitalization for COVID-19) infection (within 6 months of the Screening Visit)

• Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)

• Participant has a history of diabetes that is not well controlled with diet or stable doses of oral medications

• Participant has a corrected QT interval (QTc) >450 msec

• Participant has received any prescription or nonprescription medicines, including over the counter remedies and herbal and dietary supplements (other than vitamins within recommended daily dose limits) within 14 days (or 5 half-lives of the respective drug, whichever is longer) prior to the Baseline Visit, other than occasional use of analgesics such as paracetamol (acetaminophen, with or without caffeine, with a maximal dose of 4 g/day and 10 g/14 days) or inhaled corticosteroids for seasonal rhinitis or inhaled bronchodilators for mild asthma

• Participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or within 90 days after the final dose of IMP

• Participant has been treated with biologic agents (such as mAbs, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the Baseline Visit

• Participant has participated in another study of an IMP within the previous 90 days or 5 half-lives of IMP (whichever longer) or is currently participating in another study of an IMP

• Participant has sensitivity to heparin or heparin-induced thrombocytopenia