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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single-dose in healthy Caucasian and Japanese participants.

Eligibility Criteria

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

I have a history of diabetes.

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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