A First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB3101 in H… (NCT06555601) | Clinical Trial Compass
TerminatedPhase 1
A First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB3101 in Healthy Participants
Stopped: sponsor decision
Belgium56 participantsStarted 2024-07-31
Plain-language summary
The purpose of the study is to evaluate the safety and tolerability of a single ascending dose of UCB3101 in cohorts of healthy male and female study participants.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent form (ICF).
* Participants are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
* Participants with clinical laboratory test results within the reference ranges of the laboratory. Isolated test results that are outside the specified ranges and that are deemed clinically nonsignificant are allowed at the discretion of the investigator (except for liver enzymes). If a participant has 1 isolated test result outside the specific range for which the clinical significance is uncertain, repeat testing may be allowed at the discretion of the investigator.
* Participants are non-tobacco users or have given up smoking for at least 6 months prior to Screening.
* Participants have received a COVID-19 vaccine, including 2 boosters.
* Participants with body weight within 50.0 to 110.0kg and body mass index within the range 18.0 to 30.0kg/m2 (\~40 to 66lbs/m2) (inclusive).
* Participant is male or female.
1. Male participants must refrain from donating sperm for the duration of the study and for 3 months after planned completion of the study. A male participant with a female partner who is a woman of childbearing potential (WOCBP) must agree to use contraception for the duration of the study and for 3 months after planned completion of the study.
2. A female participant is eligible to parti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of any treatment- emergent adverse events (TEAE)
Timeframe: From Baseline to Safety Follow-up (up to Week 21)