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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: UPB-101

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).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Richmond Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group 1; Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants	Drug: UPB-101; UPB-101 Subcutaneous injection; Other Names: Formerly ASP7266
Experimental: Treatment Group 2; Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants	Drug: UPB-101; UPB-101 Subcutaneous injection; Other Names: Formerly ASP7266
Experimental: Treatment Group 3; Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants	Drug: UPB-101; UPB-101 Subcutaneous injection; Other Names: Formerly ASP7266
Experimental: Treatment Group 4; Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants	Drug: UPB-101; UPB-101 Subcutaneous injection; Other Names: Formerly ASP7266

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Concentration (Cmax) of UPB-101	Non-compartmental analysis was used for estimation of PK parameters.	Baseline through Day 85
Time to Maximum Observed Concentration (Tmax) of UPB-101	Non-compartmental analysis was used for estimation of PK parameters.	Baseline through Day 85
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	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	Safety endpoints included AEs, SAEs, physical examinations, clinical laboratory assessments, vital signs, ECGs including telemetry, withdrawal of participants, and early terminations.	Baseline through Day 85
Immunogenicity Assessment of UPB-101 When Administered to Japanese and NJNEA Adults	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.	Baseline through Day 85

Collaborators and Investigators

• Sponsor: Upstream Bio Inc.
• Investigators: Study Director: Chaim Brickman, Upstream Bio

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): May 13, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: UPB-CP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No