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

NCT ID: NCT05653479

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2023-05-13

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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group 1

Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants

Group Type: EXPERIMENTAL

UPB-101

Intervention Type: DRUG

UPB-101 Subcutaneous injection

Treatment Group 2

Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants

Group Type: EXPERIMENTAL

UPB-101

Intervention Type: DRUG

UPB-101 Subcutaneous injection

Treatment Group 3

Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants

Group Type: EXPERIMENTAL

UPB-101

Intervention Type: DRUG

UPB-101 Subcutaneous injection

Treatment Group 4

Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants

Group Type: EXPERIMENTAL

UPB-101

Intervention Type: DRUG

UPB-101 Subcutaneous injection

Interventions

UPB-101

UPB-101 Subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Formerly ASP7266

Eligibility Criteria

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)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Upstream Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chaim Brickman

Role: STUDY_DIRECTOR

Upstream Bio

Locations

Richmond Pharmacology

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UPB-CP-02

Identifier Type: -

Identifier Source: org_study_id