A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Donzakimig; Drug: Placebo

• Registration Number: NCT06716879
• Lead Sponsor: UCB Biopharma SRL

Brief Summary

The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic parameters of 2 dose strengths of donzakimig, each administered subcutaneously as a single dose, in healthy Chinese and Japanese study participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Study First Posted: 2024-12-04
• Study Start: 2024-12-06
• Status Verified: 2025-04
• Primary Completion: 2025-04-04
• Study Completion: 2025-04-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose of donzakimig in Japanese participants	Donzakimig	Japanese participants will be randomized to receive a predefined dosage of donzakimig.
High Dose of donzakimig in Japanese participants	Donzakimig	Japanese participants will be randomized to receive a predefined dosage of donzakimig.
Low Dose of placebo in Japanese participants	Placebo	Japanese participants will be randomized to receive a predefined dosage of placebo.
High Dose of placebo in Japanese participants	Placebo	Japanese participants will be randomized to receive a predefined dosage of placebo.
Low Dose of donzakimig in Chinese participants	Donzakimig	Chinese participants will be randomized to receive a predefined dosage of donzakimig.
High Dose of donzakimig in Chinese participants	Donzakimig	Chinese participants will be randomized to receive a predefined dosage of donzakimig.
Low Dose of placebo in Chinese participants	Placebo	Chinese participants will be randomized to receive a predefined dosage of placebo.
High Dose of placebo in Chinese participants	Placebo	Chinese participants will be randomized to receive a predefined dosage of placebo.

Primary Outcome Measures

Name	Time	Method
Occurrence of treatment-emergent adverse events (TEAEs)	From Baseline to End of Study visit (up to Day 57)	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. Treatment emergent adverse events (TEAEs) are adverse events not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency
Occurrence of serious treatment-emergent adverse events (serious TEAEs)	From Baseline to End of Study visit (up to Day 57)	A serious treatment-emergent adverse event (serious TEAE) is defined as any untoward medical occurrence that, at any dose: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical events
Maximum plasma concentration (Cmax) of donzakimig	Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration.	Cmax: Maximum plasma concentration of donzakimig
Area under the plasma concentration-time curve from time 0 to t of donzakimig	Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration.	AUC0-t: Area under the plasma concentration-time curve from from 0 to the time (t) of the last quantifiable concentration.
Area under the plasma concentration-time curve from zero to infinity of donzakimig	Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration.	AUC: Area under the plasma concentration-time curve from zero to infinity of donzakimig

Trial Locations

Locations (1)

UP0142 1; 🇺🇸 Anaheim, California, United States