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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05653479

Enrollment

Registered

2022-12-16

Start date

2022-12-05

Completion date

2023-05-13

Last updated

2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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 participants 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

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).

Interventions

DRUGUPB-101

UPB-101 Subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

Main Inclusion Criteria: 1. Male or female, aged ≥18 to ≤40 years at the date of signing informed consent 2. Body mass index (BMI) between 18 and 25 kg/m2 3. For Japanese (treatment groups 1, 2 and 3), participants must be: 1. Born in Japan, holding a Japanese passport, 2. Not living outside Japan for more than 5 years at the date of signing informed consent, 3. Have all 4 grandparents Japanese For NJNEA treatment group 4, participants must be: 4. Non-Japanese, 5. Non-East Asian (Chinese, Korean, Mongolian or Taiwanese). 4. Healthy, as defined by: 1. The absence of clinically significant illness and surgery within 4 weeks prior to dosing. 2. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. 5. Agrees to follow the required contraceptive techniques. 6. 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

1. 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. 2. 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. 3. Previous exposure or current infection with Hepatitis B, Hepatitis C, tuberculosis (TB), other active recent infection, or history of any untreated or unresolved infection, including parasitic infection. 4. Pregnant or breastfeeding female. 5. Previous exposure to the study drug or known allergy/sensitivity to any of its ingredients. 6. 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. 7. Use of tobacco or other nicotine-containing products in any form within 3 months prior to Day 1. 8. Any recent vaccination, prescription or over-the-counter medication, including herbal remedies or dietary supplements. 9. Recent donation of blood or blood products.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Observed Concentration (Cmax) of UPB-101	Baseline through Day 85	Non-compartmental analysis was used for estimation of PK parameters.
Time to Maximum Observed Concentration (Tmax) of UPB-101	Baseline through Day 85	Non-compartmental analysis was used for estimation of PK parameters.
AUC From Time Zero up to the Last Quantifiable Concentration of UPB-101 (AUClast)	Baseline through Day 85	Non-compartmental analysis was used for estimation of PK parameters. AUC = Area under the concentration-time curve

Secondary

Measure	Time frame	Description
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events	Baseline through Day 85	Safety endpoints included AEs, SAEs, physical examinations, clinical laboratory assessments, vital signs, ECGs including telemetry, withdrawal of participants, and early terminations.
Immunogenicity Assessment of UPB-101 When Administered to Japanese and NJNEA Adults	Baseline through Day 85	The immunogenicity endpoints included UPB-101 Anti-Drug Antibodies (ADAs). Outcome data is the number of participants with Low titer ADA positive results (range 60-240) observed at Day 85.

Countries

United Kingdom

Participant flow

Recruitment details

Treatment groups 1, 2, and 3 consisted of Japanese adults who were administered a single SC dose of a low, medium, or high dose of UPB-101, respectively. Treatment group 4 consisted of NJNEA participants who received a single SC dose of a high dose UPB-101.

Participants by arm

Arm	Count
Low Dose, Japanese Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants UPB-101: UPB-101 Subcutaneous injection	8
Medium Dose, Japanese Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants UPB-101: UPB-101 Subcutaneous injection	8
High Dose, Japanese Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants UPB-101: UPB-101 Subcutaneous injection	8
High Dose, NJNEA Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants UPB-101: UPB-101 Subcutaneous injection	8
Total	32

Baseline characteristics

Characteristic	Low Dose, Japanese	Medium Dose, Japanese	High Dose, Japanese	High Dose, NJNEA	Total
Age, Continuous	31.0 years STANDARD_DEVIATION 5.66	28.6 years STANDARD_DEVIATION 5.42	31.9 years STANDARD_DEVIATION 5.46	25.1 years STANDARD_DEVIATION 3.68	29.2 years STANDARD_DEVIATION 5.1
Body Mass Index	20.7 kg/m^2 STANDARD_DEVIATION 0.81	21.2 kg/m^2 STANDARD_DEVIATION 1.77	20.1 kg/m^2 STANDARD_DEVIATION 1.77	21.7 kg/m^2 STANDARD_DEVIATION 1.73	20.9 kg/m^2 STANDARD_DEVIATION 1.5
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	8 Participants	8 Participants	8 Participants	1 Participants	25 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants	5 Participants	5 Participants
Region of Enrollment United Kingdom	8 participants	8 participants	8 participants	8 participants	32 participants
Sex: Female, Male Female	3 Participants	2 Participants	6 Participants	4 Participants	15 Participants
Sex: Female, Male Male	5 Participants	6 Participants	2 Participants	4 Participants	17 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 8	0 / 8	0 / 8
other Total, other adverse events	4 / 8	4 / 8	7 / 8	8 / 8
serious Total, serious adverse events	0 / 8	0 / 8	0 / 8	0 / 8

Outcome results

Primary

AUC From Time Zero up to the Last Quantifiable Concentration of UPB-101 (AUClast)

Non-compartmental analysis was used for estimation of PK parameters. AUC = Area under the concentration-time curve