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

NCT05653479 | Completed Phase 1 Results

• 1 other identifier: UPB-CP-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events

  Baseline through Day 85

• Immunogenicity Assessment of UPB-101 When Administered to Japanese and NJNEA Adults

  Baseline through Day 85

Study Arms (4)

Treatment Group 1

EXPERIMENTAL

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

Drug: UPB-101

Treatment Group 2

EXPERIMENTAL

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

Drug: UPB-101

Treatment Group 3

EXPERIMENTAL

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

Drug: UPB-101

Treatment Group 4

EXPERIMENTAL

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

Drug: UPB-101

Interventions

UPB-101 DRUG

UPB-101 Subcutaneous injection

Also known as: Formerly ASP7266

Treatment Group 1; Treatment Group 2; Treatment Group 3; Treatment Group 4

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged ≥18 to ≤40 years at the date of signing informed consent
• Body mass index (BMI) between 18 and 25 kg/m2
• For Japanese (treatment groups 1, 2 and 3), participants must be:
• Born in Japan, holding a Japanese passport,
• Not living outside Japan for more than 5 years at the date of signing informed consent,
• Have all 4 grandparents Japanese
• For NJNEA treatment group 4, participants must be:
• Non-Japanese,
• Non-East Asian (Chinese, Korean, Mongolian or Taiwanese).
• Healthy, as defined by:
• The absence of clinically significant illness and surgery within 4 weeks prior to dosing.
• 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)

You may not qualify if:

• 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, Hepatitis C, 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.

Sponsors & Collaborators

• Upstream Bio Inc.: lead

Study Sites (1)

Richmond Pharmacology

London, United Kingdom

Location

Results Point of Contact

• Title: Sumathi Sivapalasingam, Vice President of Clinical Development
• Organization: Upstream Bio

sumathi.sivapalasingam@upstreambio.com

1 917-499-0789

Study Officials

• Chaim Brickman

  Upstream Bio

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 16, 2022
• Study Start: December 5, 2022
• Primary Completion: April 7, 2023
• Study Completion: May 13, 2023
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)