Safety and Blood Levels After a Single Injection of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults

Study Overview
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Brief Summary
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The goals of this clinical study are to characterize and compare the safety, tolerability, blood levels of UPB-101 when given to healthy Japanese and non-Japanese non-East Asian (NJNEA) adults. Eligible participant will be assigned to one of the 4 planned dosing treatment groups. Treatment groups 1, 2 and 3 will consist of Japanese adults who will be administered a single subcutaneous (SC) dose of UPB-101 (at 3 different strengths). Treatment group 4 will consist of NJNEA participants who will receive a single SC dose of UPB-101. All treatment groups will enroll and run in parallel.

Detailed Description
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This is a randomized, open-label, parallel group, ethno-bridging study comparing the pharmacokinetics and safety of a single dose of UPB-101 in healthy Japanese and NJNEA adults. The study will include 4 planned dosing treatment groups. Treatment groups 1, 2 and 3 will consist of Japanese adults who will be administered a single subcutaneous (SC) dose of UPB-101 (at 3 different strengths). Treatment group 4 will consist of NJNEA participants who will receive a single SC dose of UPB-101. All treatment groups will enroll and run in parallel. Japanese participants will be enrolled and randomized on Day 1 into treatment groups 1, 2 or 3 and NJNEA participants will be assigned to treatment group 4. Eight participants will be enrolled per treatment group, all will receive a single dose of UPB-101. Thus, a total of 32 male and female participants will be enrolled in the study (24 Japanese participants in treatment groups 1-3 and 8 NJNEA participants in treatment group 4).

Official Title
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A Randomized, Open-label, Parallel-group, Ethno-bridging Study Comparing the Pharmacokinetics and Safety of a Single Dose of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults

Conditions
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Healthy

Intervention / Treatment
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* Drug: UPB-101


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Male or female, aged 18 to 40 Body mass index (BMI) between 18 and 25 kg/m2 For Japanese (treatment groups 1, 2 and 3), participants must be: a) born in Japan, holding a Japanese passport, b) not living outside Japan for more than 5 years at the date of signing informed consent, c) have all 4 grandparents Japanese. For NJNEA treatment group 4, participants must be: a) Non-Japanese, b) Non-East Asian (Chinese, Korean, Mongolian or Taiwanese). Healthy, as defined by: a) the absence of clinically significant illness and surgery within four weeks prior to dosing. b) the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. Agrees to follow the required contraceptive techniques Agrees not to donate sperm or ova from the time of the administration of study medication until three months later (120 days) Main Exclusion Criteria: Current or recurrent disease (or condition), which may put the participant at risk, influence the results of the study, or otherwise affect their ability to participate in the study Vital signs consistently outside the normal range at Screening or Day -1 and any other abnormal findings or vital signs, ECG, telemetry, physical examination or laboratory evaluation of blood and urine samples that the Investigator judges as likely to interfere with the study or pose an additional risk in participating. Previous exposure or current infection with hepatitis B, C or tuberculosis (TB), other active recent infection, or history of any untreated or unresolved infection, including parasitic infection Pregnant or breastfeeding female Previous exposure to the study drug or known allergy/sensitivity to any of its ingredients Positive test results for alcohol or drugs of abuse (including cotinine) at Screening or Day -1, or history or clinical evidence of substance and/or alcohol abuse within 2 years before screening Use of tobacco or other nicotine-containing products in any form within 3 months prior to Day 1 Any recent vaccination, prescription or over-the-counter medication, including herbal remedies or dietary supplements Recent donation of blood or blood products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All treatment groups will enroll and run in parallel. Japanese participants will be enrolled and randomly assigned, on Day 1, to treatment groups 1, 2 or 3. NJNEA participants will be assigned to treatment group 4.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br>Single subcutaneous injection of a dose of UPB-101 (formerly ASP7266) in 8 Japanese participants | Drug: UPB-101<br>* UPB-101 Subcutaneous injection<br>* Other names: Formerly ASP7266;|
| Experimental: Treatment Group 2<br>Single subcutaneous injection of a dose of UPB-101 (formerly ASP7266) in 8 Japanese participants | Drug: UPB-101<br>* UPB-101 Subcutaneous injection<br>* Other names: Formerly ASP7266;|
| Experimental: Treatment Group 3<br>Single subcutaneous injection of a dose of UPB-101 (formerly ASP7266) in 8 Japanese participants | Drug: UPB-101<br>* UPB-101 Subcutaneous injection<br>* Other names: Formerly ASP7266;|
| Experimental: Treatment Group 4<br>Single subcutaneous injection of a dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants | Drug: UPB-101<br>* UPB-101 Subcutaneous injection<br>* Other names: Formerly ASP7266;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration of UPB-101 |  | Baseline through Day 85 | 
| Time to maximum observed concentration of UPB-101 |  | Baseline through Day 85 | 
| Area under the concentration-time curve from time zero up to the last quantifiable concentration of UPB-101 |  | Baseline through Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-emergent adverse events and serious adverse events |  | Baseline through Day 85 |