HealthyPhase 1NCT05653479
Safety and Blood Levels After a Single Injection of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults
A Phase 1 study testing UPB-101 in people with Healthy, run by Upstream Bio Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- UPB-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Dec 2022to 13 May 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- 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)
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, 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- UPB-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPB-101Drug
Also called Formerly ASP7266
UPB-101 Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants Receives: Drug: UPB-101 |
| Treatment Group 2 | Experimental | Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants Receives: Drug: UPB-101 |
| Treatment Group 3 | Experimental | Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants Receives: 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 Receives: Drug: UPB-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of UPB-101
Non-compartmental analysis was used for estimation of PK parameters.
Measured: Baseline through Day 85
Time to Maximum Observed Concentration (Tmax) of UPB-101
Non-compartmental analysis was used for estimation of PK parameters.
Measured: 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
Measured: Baseline through Day 85
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline through Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start5 Dec 2022
- Primary completion7 Apr 2023
- Study completion13 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Upstream Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chaim Brickman, Study director, Upstream Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653479
- Sponsor's protocol ID
- UPB-CP-02
- Status last verified
- Apr 2024
- First submitted
- 7 Dec 2022
- Last updated
- 3 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05653479
- Acronym / sponsor ID
- UPB-CP-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Upstream Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 13 May 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: UPB-101Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants |
| Treatment Group 2 | Experimental | Drug: UPB-101Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants |
| Treatment Group 3 | Experimental | Drug: UPB-101Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants |
| Treatment Group 4 | Experimental | Drug: UPB-101Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UPB-101Also: Formerly ASP7266UPB-101 Subcutaneous injection | Drug | Treatment Group 1, Treatment Group 2, Treatment Group 3, Treatment Group 4 |
Primary outcome
Maximum Observed Concentration (Cmax) of UPB-101
Time frame: Baseline through Day 85
Non-compartmental analysis was used for estimation of PK parameters.
Time to Maximum Observed Concentration (Tmax) of UPB-101
Time frame: 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)
Time frame: Baseline through Day 85
Non-compartmental analysis was used for estimation of PK parameters. AUC = Area under the concentration-time curve
2 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
Time frame: Baseline through Day 85
Immunogenicity Assessment of UPB-101 When Administered to Japanese and NJNEA Adults
Time frame: Baseline through Day 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaim Brickman study director
Upstream Bio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UPB-101 in people with Healthy, run by Upstream Bio Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Concentration (Cmax) of UPB-101 (time frame: Baseline through Day 85). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.