Donzakimig Safety Study in Healthy Subjects

Overseen By UCB Cares

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: UCB Biopharma SRL

Disqualifiers: Drug allergies, Recent infections, Diabetes, Inflammatory bowel disease, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new treatment called donzakimig (also known as UCB-1381) in healthy Chinese and Japanese participants. Researchers aim to observe how the body processes different doses and identify any side effects. Participants will receive either donzakimig or a placebo (a harmless, inactive substance) for comparison. The trial suits individuals who are healthy, of Chinese or Japanese descent, and free from recent infections or allergies. 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 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.

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

Research has shown that donzakimig, also known as UCB1381, has undergone safety testing in healthy individuals. Early studies examined various doses administered either intravenously or subcutaneously to assess tolerability. Although detailed safety results are not fully available, testing on healthy participants helps researchers understand the drug's effects without interference from other health issues.

As this trial is in an early stage, it primarily focuses on safety. The treatment is closely monitored for side effects. Early trials typically involve fewer participants and carefully assess treatment tolerance. This process helps identify and address potential risks as the study progresses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about donzakimig because it offers a fresh approach compared to existing treatments. Most current therapies for autoimmune conditions work by broadly dampening the immune response, often leading to significant side effects. Donzakimig, however, targets specific pathways in the immune system, potentially reducing these side effects while maintaining its effectiveness. This precision in action is what sets donzakimig apart and fuels optimism about its potential benefits.

What evidence suggests that donzakimig could be effective?

Research has not yet provided specific information on how well donzakimig works for any particular condition. Studies so far have mainly focused on its safety, tolerability, and behavior in the bodies of healthy participants. In this trial, participants will be randomized into different arms to receive either low or high doses of donzakimig or a placebo. Donzakimig, also known as UCB1381, remains under study, with no published results on its effectiveness in treating diseases. The main goal has been to ensure its safety before exploring potential benefits for specific health issues. Understanding its safety will allow future studies to better explore its effectiveness for certain conditions. ^{1 2 3 4 6}

Who Is on the Research Team?

UCB Cares

Principal Investigator

0018445992273

Are You a Good Fit for This Trial?

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 of Chinese or Japanese descent with all 4 grandparents also being of the same descent.

I am generally healthy as confirmed by a medical exam and tests.

My BMI is between 18 and 30.

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 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Low Dose of donzakimig in Japanese participants Experimental Treatment 1 Intervention

Japanese participants will be randomized to receive a predefined dosage of donzakimig.

Group II: Low Dose of donzakimig in Chinese participants Experimental Treatment 1 Intervention

Chinese participants will be randomized to receive a predefined dosage of donzakimig.

Group III: High Dose of donzakimig in Japanese participants Experimental Treatment 1 Intervention

Japanese participants will be randomized to receive a predefined dosage of donzakimig.

Group IV: High Dose of donzakimig in Chinese participants Experimental Treatment 1 Intervention

Chinese participants will be randomized to receive a predefined dosage of donzakimig.

Group V: Low Dose of placebo in Japanese participants Placebo Group 1 Intervention

Japanese participants will be randomized to receive a predefined dosage of placebo.

Group VI: High Dose of placebo in Japanese participants Placebo Group 1 Intervention

Japanese participants will be randomized to receive a predefined dosage of placebo.

Group VII: Low Dose of placebo in Chinese participants Placebo Group 1 Intervention

Chinese participants will be randomized to receive a predefined dosage of placebo.

Group VIII: High Dose of placebo in Chinese participants Placebo Group 1 Intervention

Chinese participants will be randomized to receive a predefined dosage of 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

Published Research Related to This Trial

In a study involving 6,005 patients with type 2 diabetes, dulaglutide was associated with a low incidence of acute pancreatitis, with only 3 confirmed cases among those treated, which is comparable to the placebo group.

The exposure-adjusted incidence rate of acute pancreatitis was 0.85 patients per 1,000 patient-years for dulaglutide, significantly lower than the rates for placebo (3.52) and sitagliptin (4.71), suggesting that dulaglutide has a favorable safety profile regarding pancreatitis risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Pancreas Safety in the Development Program of Once-Weekly GLP-1 Receptor Agonist Dulaglutide. Nauck, MA., Frossard, JL., Barkin, JS., et al.[2018]

In a study of 9876 participants, dulaglutide 1.5 mg was found to effectively reduce HbA1c levels more in patients with higher baseline HbA1c (7% or higher), while also showing positive cardiovascular and weight outcomes regardless of initial HbA1c levels.

The treatment demonstrated a favorable safety profile and can be recommended for patients with well-controlled HbA1c levels who are looking for additional metabolic and cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety outcomes of dulaglutide by baseline HbA1c: A post hoc analysis of the REWIND trial. Franek, E., Gerstein, HC., Riddle, MC., et al.[2022]

A biosimilar version of liraglutide was found to be bioequivalent to the original drug in a study involving 32 healthy volunteers, with pharmacokinetic parameters (Cmax and AUC0-t) showing similar results, indicating it should work similarly in controlling blood sugar levels for type 2 diabetes patients.

Both the biosimilar and the original liraglutide demonstrated a favorable safety profile, with mostly mild gastrointestinal side effects, suggesting that the new formulation is safe for further testing in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single-dose, Two-Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects. Feng, S., Cai, L., Wang, X., et al.[2023]

In a 52-week study involving 492 Japanese patients with type 2 diabetes, once-weekly dulaglutide (0.75 mg) was found to be superior to placebo and equally effective as once-daily liraglutide (0.9 mg) in reducing HbA1c levels after 26 weeks.

Dulaglutide was generally safe and well tolerated, with only mild adverse events reported, and a lower incidence of decreased appetite compared to liraglutide, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Miyagawa, J., Odawara, M., Takamura, T., et al.[2022]

A systematic review of 35 randomized controlled trials involving 44,912 patients with type 2 diabetes found that SGLT2 inhibitors do not significantly increase the risk of acute pancreatitis compared to controls, with moderate quality evidence supporting this conclusion.

The study also indicated no significant association between SGLT2 inhibitors and pancreatic cancer, although the evidence for this was of very low quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic safety of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: A systematic review and meta-analysis. Tang, H., Yang, K., Li, X., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Janus kinase inhibitors, including new compounds like filgotinib and upadacitinib, show promising fast and dose-dependent clinical improvements in treating rheumatoid arthritis, comparable to existing treatments like tofacitinib and baricitinib.

While these new drugs have similar adverse events, some side effects are specific to individual drugs, highlighting the need for thorough phase III trials and safety evaluations to optimize their use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of new JAK inhibitors under development. Just more of the same? Westhovens, R.[2023]

In a study of 115 non-elderly patients with rheumatoid arthritis treated with tacrolimus for 76 weeks, the safety profile showed that 33.9% experienced adverse drug reactions, primarily gastrointestinal disorders and hypertension.

The treatment resulted in ACR20 response rates of 61.5% for patients previously on tacrolimus and 66.0% for those on mizoribine, indicating that long-term tacrolimus therapy is effective and maintains a safety profile consistent with earlier studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of long-term tacrolimus therapy for rheumatoid arthritis: an open-label, uncontrolled study in non-elderly patients. Kawai, S., Tanaka, K., Ohno, I., et al.[2016]

In a 52-week study involving 394 Japanese patients with type 2 diabetes, once weekly dulaglutide 0.75 mg significantly reduced HbA1c levels across various oral hypoglycemic agent combinations, demonstrating its efficacy in improving glycemic control.

The treatment was generally well tolerated, with common side effects including nasopharyngitis and gastrointestinal issues, but no severe hypoglycemic episodes were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Emoto, M., Terauchi, Y., Ozeki, A., et al.[2022]

The maximum-tolerated dose (MTD) of the dolastatin 15 analog LU103793 was determined to be 2.5 mg/m2 per day, with dose-limiting toxicities including neutropenia and liver function abnormalities observed at higher doses.

LU103793 demonstrated a manageable safety profile with no significant cardiovascular effects, supporting its further evaluation in targeted cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I and pharmacokinetic study of the water-soluble dolastatin 15 analog LU103793 in patients with advanced solid malignancies. Villalona-Calero, MA., Baker, SD., Hammond, L., et al.[2017]

In a 24-week study involving 300 patients with type 2 diabetes, once-weekly dulaglutide 1.5 mg significantly reduced HbA1c levels by 1.3% compared to placebo, indicating its efficacy in improving glycemic control.

Dulaglutide was associated with common gastrointestinal side effects, such as nausea and diarrhea, but showed a favorable safety profile with no reports of severe hypoglycemia, suggesting it is a safe option when added to glimepiride therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Dungan, KM., Weitgasser, R., Perez Manghi, F., et al.[2022]

In a study of 361 Japanese patients with type 2 diabetes, once-weekly dulaglutide 0.75 mg showed consistent efficacy in reducing HbA1c levels across different subgroups, regardless of the oral hypoglycemic agents used.

Dulaglutide was associated with weight loss, particularly when combined with biguanide (BG) alone or with sulphonylurea (SU) and BG, while the incidence of adverse events was stable across dulaglutide subgroups, contrasting with significant differences observed in the insulin glargine group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combination of dulaglutide and biguanide reduced bodyweight in Japanese patients with type 2 diabetes. Inagaki, N., Araki, E., Oura, T., et al.[2022]

The study found that LY05008, a biosimilar to dulaglutide, showed pharmacokinetic (PK) profiles that are similar to those of the licensed dulaglutide, indicating that it can be expected to have similar effects in the body.

Safety and immunogenicity profiles were comparable between LY05008 and dulaglutide, suggesting that LY05008 is a safe alternative for improving glycemic control and reducing cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects. Zhang, Q., Sun, C., Wu, J., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05277571

Study Details | NCT05277571 | A Single-ascending Dose ... The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study ...

2. ucb.com ucb.com/innovation/clinical-studies/clinical-studies-index/UCB1381

UCB1381 A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy ...

3. withpower.com withpower.com/trial/donzakimig-safety-study-in-healthy-subjects-ff7b7

Donzakimig Safety Study in Healthy Subjects The available research does not provide any specific data on the effectiveness of Donzakimig, UCB-1381. The studies mentioned focus on other drugs and ...

4. delta.larvol.com delta.larvol.com/Products/?ProductId=0f80552a-c393-478f-9755-efa980707be5

donzakimig (UCB1381) / UCB A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants (clinicaltrials ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06716879

NCT06716879 | A Study to Evaluate Safety, Tolerability, ... The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic parameters of 2 dose strengths of donzakimig, each administered ...

6. ctv.veeva.com ctv.veeva.com/study/a-single-ascending-dose-part-a-and-repeat-dose-part-b-study-to-investigate-the-safety-pharmacok

A Single-ascending Dose (Part A) and Repeat-dose (Part B ... The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study ...