32 Participants Needed

Donzakimig Safety Study in Healthy Subjects

UC
Overseen ByUCB Cares
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: UCB Biopharma SRL

Trial Summary

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

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants, it's likely that you should not be on any significant medications. Please consult with the trial coordinator for specific guidance.

What data supports the idea that Donzakimig Safety Study in Healthy Subjects (also known as: Donzakimig, UCB-1381) is an effective drug?

The available research does not provide any specific data on the effectiveness of Donzakimig, UCB-1381. The studies mentioned focus on other drugs and treatments for conditions like osteoporosis, leukemia, and rheumatoid arthritis, but none of them discuss Donzakimig or its effectiveness for any condition.12345

What existing safety data is available for Donzakimig (UCB-1381)?

The provided research does not contain any safety data for Donzakimig (UCB-1381). The studies focus on other treatments such as dulaglutide and LU103793, and do not mention Donzakimig or UCB-1381.678910

Is the drug Donzakimig a promising treatment?

The information provided does not include any details about Donzakimig or its potential as a treatment, so we cannot determine if it is promising based on this data.1112131415

What is the purpose of this trial?

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.

Research Team

UC

UCB Cares

Principal Investigator

0018445992273

Eligibility Criteria

This trial is for healthy Chinese and Japanese adults aged 18-55 with a BMI of 18 to 30kg/m2. Participants must be in good health as confirmed by medical exams, tests, and cardiac assessment. They should also have all four grandparents of the same descent (Chinese or Japanese) as themselves.

Inclusion Criteria

I am generally healthy as confirmed by a medical exam and tests.
I am of Chinese or Japanese descent with all 4 grandparents also being of the same descent.
My BMI is between 18 and 30.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of donzakimig 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) on Day 1, Day 2, Day 4, Day 6, Day 8, Day 15, Day 22, Day 36, and Day 57

Treatment Details

Interventions

  • Donzakimig
Trial Overview The study is testing the safety and how the body processes a single dose of Donzakimig, compared to a placebo. Two different strengths of Donzakimig will be given through an under-the-skin injection to see how participants' bodies react over time.
Participant Groups
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose of donzakimig in Japanese participantsExperimental Treatment1 Intervention
Japanese participants will be randomized to receive a predefined dosage of donzakimig.
Group II: Low Dose of donzakimig in Chinese participantsExperimental Treatment1 Intervention
Chinese participants will be randomized to receive a predefined dosage of donzakimig.
Group III: High Dose of donzakimig in Japanese participantsExperimental Treatment1 Intervention
Japanese participants will be randomized to receive a predefined dosage of donzakimig.
Group IV: High Dose of donzakimig in Chinese participantsExperimental Treatment1 Intervention
Chinese participants will be randomized to receive a predefined dosage of donzakimig.
Group V: Low Dose of placebo in Japanese participantsPlacebo Group1 Intervention
Japanese participants will be randomized to receive a predefined dosage of placebo.
Group VI: High Dose of placebo in Japanese participantsPlacebo Group1 Intervention
Japanese participants will be randomized to receive a predefined dosage of placebo.
Group VII: Low Dose of placebo in Chinese participantsPlacebo Group1 Intervention
Chinese participants will be randomized to receive a predefined dosage of placebo.
Group VIII: High Dose of placebo in Chinese participantsPlacebo Group1 Intervention
Chinese participants will be randomized to receive a predefined dosage of placebo.

Find a Clinic Near You

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

Findings from Research

In a study of 286 patients with osteoporosis, odanacatib significantly increased bone mineral density (BMD) at the lumbar spine and hip sites after 52 weeks of treatment, with the highest doses (25 mg and 50 mg) showing the greatest improvements.
Odanacatib was well tolerated, with no significant safety concerns or dose-related adverse events reported, indicating it is a safe option for increasing BMD in patients with osteoporosis.
Effect of the cathepsin K inhibitor odanacatib administered once weekly on bone mineral density in Japanese patients with osteoporosis--a double-blind, randomized, dose-finding study.Nakamura, T., Shiraki, M., Fukunaga, M., et al.[2021]
Ponatinib is an effective treatment for chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), particularly for patients who are resistant to other therapies, achieving significant response rates in clinical trials.
The drug is specifically designed to target the T315I mutation, which makes it unique among other tyrosine kinase inhibitors, but it also carries risks of severe side effects like myelosuppression and arterial thrombosis, indicating it should be used cautiously.
Ponatinib: A new tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.Shamroe, CL., Comeau, JM.[2013]
In a study of 3179 rheumatoid arthritis patients treated with either Janus kinase inhibitors (JAKis) or tumor necrosis factor inhibitors (TNFis), both treatments showed comparable safety outcomes over an average follow-up of about 2 years.
Although the JAKis group exhibited a lower incidence rate of safety outcomes like cardiovascular events and total joint replacements compared to the TNFis group, these differences were not statistically significant, indicating similar safety profiles for both treatments.
Comparative safety of Janus kinase inhibitors and tumor necrosis factor inhibitors in patients undergoing treatment for rheumatoid arthritis.Fang, YF., Liu, JR., Chang, SH., et al.[2022]

References

Effect of the cathepsin K inhibitor odanacatib administered once weekly on bone mineral density in Japanese patients with osteoporosis--a double-blind, randomized, dose-finding study. [2021]
Ponatinib: A new tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. [2013]
Comparative safety of Janus kinase inhibitors and tumor necrosis factor inhibitors in patients undergoing treatment for rheumatoid arthritis. [2022]
Clinical efficacy of new JAK inhibitors under development. Just more of the same? [2023]
Safety of long-term tacrolimus therapy for rheumatoid arthritis: an open-label, uncontrolled study in non-elderly patients. [2016]
Assessment of Pancreas Safety in the Development Program of Once-Weekly GLP-1 Receptor Agonist Dulaglutide. [2018]
Efficacy and safety outcomes of dulaglutide by baseline HbA1c: A post hoc analysis of the REWIND trial. [2022]
Phase I and pharmacokinetic study of the water-soluble dolastatin 15 analog LU103793 in patients with advanced solid malignancies. [2017]
Pancreatic safety of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: A systematic review and meta-analysis. [2021]
A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
A Single-dose, Two-Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects. [2023]
A 1-year safety study of dulaglutide in Japanese patients with type 2 diabetes on a single oral hypoglycemic agent: an open-label, nonrandomized, phase 3 trial. [2022]
Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects. [2023]
Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide is non-inferior to once-daily liraglutide and superior to placebo in Japanese patients with type 2 diabetes: a 26-week randomized phase III study. [2022]
The combination of dulaglutide and biguanide reduced bodyweight in Japanese patients with type 2 diabetes. [2022]
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