A First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB3101 in Healthy Participants

NCT06555601 | Terminated Phase 1

• 3 other identifiers: UP01242023-504586-24U1111-1305-5063
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

UCB3101

Outcome Measures

Primary Outcomes (1)

• Incidence of any treatment- emergent adverse events (TEAE)

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

  From Baseline to Safety Follow-up (up to Week 21)

Secondary Outcomes (4)

• Incidence of any treatment-emergent Serious Adverse Events (SAE)

  From Baseline to Safety Follow-up (up to Week 21)

• Incidence of discontinuation from treatment due to treatment- emergent adverse events (TEAE)

  From Baseline to Safety Follow-up (up to Week 21)

• Maximum Serum Concentration (Cmax) of UCB3101

  From Day 1 (Predose) up to Week 21

• Area Under the Serum Concentration-Time Curve (AUC) of UCB3101

  From Day 1 (Predose) up to Week 21

Study Arms (8)

Cohort 1

EXPERIMENTAL

Study participants randomized to this arm will receive a single dose of UCB3101 (Dose 1) or placebo.

Drug: UCB3101; Drug: Placebo

Cohort 2

EXPERIMENTAL

Study participants randomized to this arm will receive a single dose of UCB3101 (Dose 2) or placebo.

Drug: UCB3101; Drug: Placebo

Cohort 3

EXPERIMENTAL

Study participants randomized to this arm will receive a single dose of UCB3101 (Dose 3) or placebo.

Drug: UCB3101; Drug: Placebo

Cohort 4

EXPERIMENTAL

Study participants randomized to this arm will receive a single dose of UCB3101 (Dose 4) or placebo.

Drug: UCB3101; Drug: Placebo

Cohort 5

EXPERIMENTAL

Study participants randomized to this arm will receive a single dose of UCB3101 (Dose 5) or placebo.

Drug: UCB3101; Drug: Placebo

Cohort 6

EXPERIMENTAL

Study participants randomized to this arm will receive a single dose of UCB3101 (Dose 6) or placebo.

Drug: UCB3101; Drug: Placebo

Cohort 7

EXPERIMENTAL

Study participants randomized to this arm will receive a single dose of UCB3101 (Dose 7) or placebo.

Drug: UCB3101; Drug: Placebo

Cohort 8

EXPERIMENTAL

Study participants randomized to this arm will receive a single dose of UCB3101 (Dose 8) or placebo.

Drug: UCB3101; Drug: Placebo

Interventions

UCB3101 DRUG

Study participants will receive UCB3101 as prespecified in each cohort.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8

Placebo DRUG

Study participants will receive placebo as prespecified in each cohort to maintain the blinding.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Vulnerable individuals (eg, individuals kept in detention, serving soldiers), employees of the Sponsor or the contract research organization (CRO), with direct involvement in the proposed study or other studies under the direction of the investigator or the CRO, as well as family members of the employees or the investigator
• Participant has any medical or psychiatric condition that jeopardize or would compromise the study participant's ability to participate in this study.
• Participant has any clinically significant Electrocardiogram (ECG) abnormalities.
• Participant has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months.
• History or presence of clinically significant respiratory, neurological, gastrointestinal, renal, hepatic, pancreatic, hematological, cardiovascular, musculoskeletal, genitourinary, immunological, or dermatological disorders.
• Participant has had prior history of lymphoma, leukemia, or any malignancy.
• Participant has a clinically significant active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection within 4 weeks before the first dose of IMP.
• Participant has had recurrent (at least 2) clinically relevant infections (eg, tooth abscess, opportunistic infections, boils, etc) in the past 6 months.
• Participant has a history of recurrent headaches, including migraine.
• Participant has evidence or history of significant active bleeding or coagulation disorder.
• Participant has a history of chronic alcohol or drug abuse within 12 months prior to Baseline.
• Participant has a history of skin disorders or extensive tattooing that prevent clear visibility of the skin in case of a hypersensitivity reaction.
• Participant has scheduled surgery between Screening and 1 month after end of study visit.
• Participant has a history of clinically significant back pain, back pathology, and/or back injury that may predispose participant to complications or technical difficulty with lumbar puncture (LP).
• Participant has medical or surgical conditions for which LP is contraindicated.

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

UP0124 1

Edegem, Belgium

Location

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 15, 2024
• Study Start: July 31, 2024
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)