UP0135 A Single-center, Placebo-controlled, Participant-blind, Investigator-blind, Randomized, Multiple Ascending Dose in Titration Study to Assess The Safety and Tolerability, and Pharmacokinetics of UCB0022 in Healthy Caucasian, Japanese, and Chinese Participants Brief summary The primary purpose of this study is to assess the safety and tolerability of oral glovadalen (UCB0022) in healthy Caucasian, Japanese, and Chinese participants. Medical Condition Healthy Study Participants Min. Age 18 Years Max. Age 55 Years Who Can Join? All Status Active, not recruiting Inclusion criteria - Healthy male and female participants must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF). - Participants who are overtly healthy (in the opinion of the investigator) as determined by medical evaluation including medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests during the Screening Period. Participants with test results that are outside the specified normal ranges and that are deemed not clinically significant will be allowed at the discretion of the investigator. If participants have a test result outside the specific range that is deemed clinically significant, repeat of the investigation may be allowed at the discretion of the investigator. - For Japanese participants: Participants are of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (participant have all 4 Japanese grandparents born in Japan) and have not had a significant change in lifestyle or diet since leaving Japan. - For Chinese participants: Participants are of Chinese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Chinese grandparents born in China) and have not had a significant change in lifestyle or diet since leaving China. - For Caucasian participants: Participants are of Caucasian descent as evidenced by appearance and verbal confirmation of familial heritage with all 4 grandparents of Caucasian descent. Weight - Participants with body weight ≥45 kilogram (kg) and body mass index (BMI) within the range of 18.0 to 30.0 kg/m^2 (inclusive). Sex and contraceptive/barrier requirements - Male and female a) Male participants must agree to use contraception of the full protocol during the Treatment Period and for 14 days after the final dose of study intervention and refrain from donating sperm during this period. b) Female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance of the full protocol during the Treatment Period and for at least 14 days after the final dose of study intervention Exclusion criteria - Participants have any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participants’ ability to participate in this study. - Participants have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, cerebrovascular, neurological, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data in the opinion of the investigator. - History of hypertension, hypertensive crisis, hypertensive encephalopathy, or orthostatic hypotension, unless the underlying cause was unequivocally identified and has been removed. - History of ischemic stroke, transient ischemic attack, angina, myocardial infarction, any systemic embolism, any clinically significant arrythmia, or congestive heart failure - Participants have the following liver enzyme test results during the Screening Period or Day -1: a) aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN), (isolated bilirubin <1.5xULN is acceptable if fractionated and direct bilirubin <35%). b) Tests that result in ALT, AST, bilirubin, or ALP up to 25% above the exclusion limit may be repeated once for confirmation. - Participants have current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones). - Participants have 12-lead ECG with changes considered to be clinically significant (eg, QTcF >450 ms in males and >470 ms in females based on average of triplicate ECGs, left bundle branch block, evidence of myocardial ischemia, or second-degree Type II atrioventricular block) during the Screening Period or Day -1. - Participants have a history of risk factors for torsades de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome). - Participants have had any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. - Participants have had breast cancer within the past 10 years. - Participants have a history of a major organ transplant or hematopoietic stem cell/marrow transplant. - Participants have a current history of alcohol or drug use disorder, as defined in Diagnostic and Statistical Manual of Mental Disorders Version 5, within the last year. - Participants have a known hypersensitivity to any components of the study intervention as stated in the protocol. - Participants have a history of severe allergic reaction that required medical intervention. - Participants have clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnea, sore throat, fatigue, anosmia, ageusia) or had a positive SARS CoV 2 test result within the last 4 weeks prior to dosing. - Active treatment or a history of glaucoma. Study Medication Description Study Medication: glovadalen Other Descriptive Name: glovadalen Placebo No Comparator: No Share this study Share Facebook Share Twitter Share LinkedIn Refer to a friend Via email Study Dates April 2025 Actual Start Date of Enrollment May 2026 Planned Study Completion Date General Information Study ID: UP0135 CT.gov Number: NCT06970301 Phase: Phase 1 Locations Click here to find out where the clinical study is conducted Interested in our clinical studies? Just contact us Austria UCBCares.AT@ucb.com +43 (0) 1 291 80 08 0800-296176 (freephone) Belgium UCBCares.BE@ucb.com +32 2 559 92 00 0800 38 008 (freephone) www.ucbcares.be Bulgaria UCBCares.BG@ucb.com +359 2 962 9933 www.ucbcares.bg Canada +1 866 709 8444 Czech Republic UCBCares.CZ@ucb.com +420 221 773 442 800 144 395 (freephone) www.ucbcares.cz Denmark UCBCares.DK@ucb.com +45 32462480 80 253827 (freephone) www.ucbcares.dk Finland UCBCares.FI@ucb.com +358 942733300 0800 9 13353 (freephone) www.ucbcares.fi France UCBCares.FR@ucb.com +33 1 47 29 45 55 0 805 222 949 (freephone) www.ucbcares.fr Germany UCBCares.DE@ucb.com +49 2173 48 48 48 www.ucbcares.de Greece UCBCares.GR@ucb.com +30 21 0997 4200 0080 012 9910 (freephone) www.ucbcares.gr Hungary UCBCares.HU@ucb.com +36 1 472 5060 06 80 021 486 (freephone) www.ucbcares.hu Ireland UCBCares.IE@ucb.com +353 1 463 2371 1800 93 00 75 (freephone) www.ucbcares.co.uk Italy UCBCares.IT@ucb.com +39 02 3007 9300 8009-86932 (freephone) www.ucbcares.it Japan https://ucbcares.jp Luxemburg UCBCares.LU@ucb.com +32 2 559 92 12 8002 3204 (freephone) Norway UCBCares.NO@ucb.com +45 32462482 800-10101 (freephone) www.ucbcares.no Poland UCBCares.PL@ucb.com +48 22 596 97 97 00 800 121 68 25 (freephone) www.ucbcares.pl Portugal UCBCares.PT@ucb.com +351 213 025 300 800-8-56033 (freephone) Romania +4021 300 19 07 Slovakia UCBCares.SK@ucb.com +421 2 592 020 23 0800 002 566 (freephone) www.ucbcares.sk Spain UCBCares.ES@ucb.com +34 915 70 06 49 8000-99684 (freephone) www.ucbcares.es Sweden UCBCares.SE@ucb.com +45 32462481 0200 898 671 (freephone) www.ucbcares.se Switzerland +41 58 822 3180 The Netherlands UCBCares.NL@ucb.com +31 76 573 1130 0800 3434335 (freephone) www.ucbcares.nl UK UCBCares.UK@ucb.com +44 1753 777 100 0800 279 3177 (freephone) www.ucbcares.co.uk USA UCBCares@ucb.com +1-844-599-2273 www.ucb-usa.com/Patients/Patients Email Print Back to results