UCB9741 for Healthy Subjects

Overseen By UCB Cares

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: UCB Biopharma SRL

Must not be taking: Biologics, mAbs, others

Disqualifiers: Drug allergies, Diabetes, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and metabolism of a potential new medicine called UCB9741. Researchers will administer single doses of the medicine through injections to healthy individuals of Caucasian and Japanese descent. The study divides participants into groups to compare different doses and a placebo (a substance with no therapeutic effect). This trial suits healthy individuals aged 18 to 55 who can confirm their Caucasian or Japanese heritage. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

Yes, you must stop taking any prescription or nonprescription medicines at least 14 days before the trial, except for contraceptives or occasional pain relievers.

Is there any evidence suggesting that UCB9741 is likely to be safe for humans?

Research has shown that UCB9741 has undergone testing in several studies to assess its safety and tolerability. In earlier research, participants received varying doses of UCB9741, either through an IV (a tube into a vein) or as an injection under the skin. These studies aimed to identify any negative side effects.

The available data suggests that participants have generally tolerated UCB9741 well. No serious health problems have been reported in these studies. However, some participants experienced mild side effects, which were neither severe nor long-lasting.

Since UCB9741 remains in early testing, researchers focus on confirming its safety for a broader population. They closely monitor all participants to ensure their safety, continuing to gather information about any less common side effects.

In summary, UCB9741 has been well-tolerated in studies so far. Researchers remain committed to ensuring the treatment's safety as testing continues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about UCB9741 because it offers a fresh approach to treatment through subcutaneous injections, potentially enhancing patient convenience compared to oral medications. Unlike standard treatments, UCB9741 is being tested at varying doses and injection volumes, which may allow for more tailored and effective dosing strategies. This could lead to optimized outcomes and reduced side effects, making it a promising option in its field.

What evidence suggests that UCB9741 could be effective?

Research shows that UCB9741 is under investigation for its potential to treat conditions like atopic dermatitis. In earlier studies, researchers tested UCB9741 to assess its safety and how it functions in the body when administered to healthy individuals and those with atopic dermatitis. While detailed results on its effectiveness for specific conditions are still forthcoming, the primary focus has been on ensuring its safety and tolerability. The drug targets specific processes involved in skin inflammation, potentially reducing symptoms like itching and redness. As more information becomes available, a clearer understanding of its effectiveness will emerge. Participants in this trial will receive either UCB9741 or a placebo, with different cohorts receiving varying dose levels and injection volumes. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-55, with a BMI of 18-30 kg/m^2. Participants must be of Caucasian or Japanese descent, confirmed by appearance and family heritage. Women can't be pregnant/breastfeeding and must use effective birth control; men must practice contraception and avoid sperm donation during the study.

Inclusion Criteria

I will use contraception and not donate sperm for 90 days during the study.

Body mass Index within the range 18 to 30 kg/m^2 (inclusive)

For Japanese subjects only: Japanese descent as evidenced in appearance and verbal confirmation of familial heritage and is of Japanese descent with all 4 grandparents

Exclusion Criteria

Study participant has a corrected QT interval (QTc) >450msec for male study participants or >470msec for female study participants

Participant has sensitivity to heparin or heparin-induced thrombocytopenia

Participant has a positive test for substance of abuse, or is a regular alcohol consumer defined as an average weekly intake of >14 units

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of UCB9741 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

8 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• UCB9741

Trial Overview The study tests the safety and how the body processes UCB9741 after a single subcutaneous dose in two different strengths compared to a placebo in healthy Caucasian and Japanese participants.

How Is the Trial Designed?

Group I: Cohort 5 (Caucasian) Experimental Treatment 2 Interventions

Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 (using a different volume per injection than cohort 3) or Placebo

Group II: Cohort 4 (Japanese) Experimental Treatment 2 Interventions

Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo

Group III: Cohort 3 (Caucasian) Experimental Treatment 2 Interventions

Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo

Group IV: Cohort 2 (Japanese) Experimental Treatment 2 Interventions

Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the lowest dose level of UCB9741 or Placebo

Group V: Cohort 1 (Caucasian) Experimental Treatment 2 Interventions

Study participants enrolled in this arm will receive either injections (sc) of the lowest dose level of UCB9741 or Placebo

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04643457

NCT04643457 | A Study to Test the Safety, ... A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis.

2. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2020-003639-41/results

EudraCT Number 2020-003639-41 - Clinical trial results Healthy participants received placebo (matching to UCB9741) as a single subcutaneous (sc) administration within each cohort of Part A on Day 1. Participant ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06315335

NCT06315335 | A Study to Assess the Safety and ... The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single- ...

4. trial.medpath.com trial.medpath.com/clinical-trial/404facbf1c5105d5/nct06315335-single-center-randomized-study-ucb9741-safety

A Study to Assess the Safety and Pharmacokinetics ... - MedPath The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous ...

5. ucb.com ucb.com/innovation/clinical-studies/clinical-studies-index/UCB9741

UCB9741 A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic Dermatitis, Phase 2 ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06315335/

Trial | NCT06315335 The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a ...