Healthy volunteers help test how a new drug is absorbed
NCT ID NCT05845645
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study looked at how a new drug, UCB0599, is absorbed in healthy adults. It also checked if stomach acid levels affect absorption and tested safety in Japanese and Chinese participants. The goal was to gather information, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- UCB0599
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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73 people
The number who actually took part.
- Started
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May 2023
- Finished
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Apr 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Part A only: all healthy study participants except for those participants who are eligible for Part B of the study * For participants of Japanese origin (Part B): study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Japanese grandparents born in Japan). For participants of Chinese origin (Part B): study participant is of Chinese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Chinese grandparents born in China). * Body weight within 45 to 100 kg (female) and 50 to 100 kg (male) and body mass index (BMI) within the range 18 to 30 kg/m\^2 (inclusive at screening) * Healthy male and female study participants Exclusion Criteria: * Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study * Participant has a history or presence of/significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological 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 * Participant has had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell carcinomas that have been resected, squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * Participant has had breast cancer within the past 10 years * Participant has a history of alcohol or drug abuse within the last 1 year from Screening, as defined according to the Diagnostic and Statistical Manual of Mental Disorders * Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol * Participant has a consumption of more than 600 mg of caffeine/day at screening and throughout the study * Participant has consumed any grapefruit, grapefruit juice, grapefruit-containing products, or star fruit within 14 days prior to administration of study medication or is not willing to refrain from consuming these products for the duration of the study * Participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study * Participant has participated in another study of a study medication (and/or an investigational device) within the previous 30 days or 5 half-lives, whichever is greatest, or is currently participating in another study of an study medication (and/or an investigational device) * Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to dosing * Positive hepatitis C antibody test (HCVAb) result at screening or within 3 months prior to starting study intervention * Positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study medication * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) * For women of childbearing potential, study participant is pregnant, planning on becoming pregnant during the study, or is breastfeeding * Participants who may have a history of confirmed gastric ulceration
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Up0073 10001
Glendale, California, 91206, United States
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