AsthmaPhase 1NCT05448651
Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in Asthmatics
A Phase 1 study testing UPB-101 in people with Asthma, run by Upstream Bio Inc. at 4 sites in United Kingdom.
Trial summary
The goals of this clinical study were to assess the safety, tolerability, blood levels, and disease impact of UPB-101 when given to adults with mild asthma. Eligible participant were consecutively assigned to 1 of 3 to 5 planned treatment groups. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- UPB-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 8 Jul 2022to 5 Oct 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged 18 to 60, and has physician-diagnosed asthma
- Body mass index (BMI) between 18 and 35 kg/m2
- Blood eosinophil cell count ≥200 (OR ≥150 combined with fractional exhaled nitric oxide [a measure of lung airway inflammation] >25) at one screening visit and ≥150 at the other screening
- Agrees to follow the required contraceptive techniques
- Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug
- Able to perform spirometry (breathing tests)
- Asthma and non-biologic asthma medication have been stable for the past 2 months
Who cannot join
- Employee, consultant, and/or immediate family member of any person involved in the conduct of the study
- Previous exposure to the study drug or known allergy/sensitivity to any of its ingredients
- Pregnant or breastfeeding female
- Unable to fast and avoid strenuous exercise for 9 hours prior to each site visit
- Serious allergic reaction to any injected drug
- Significantly abnormal clinical laboratory test results or a significant medical condition
Show all 19Show fewer
- Recently donated blood (including blood products) or experienced significant loss of blood
- Has pacemaker or a significantly abnormal electrocardiogram
- An active or a serious infection in the past 8 weeks
- Poorly-controlled diabetes or abnormal kidney function
- Tests positive to illicit drugs or nicotine and cannot limit alcohol consumption
- Tests positive for human immunodeficiency virus antibodies (HIV), hepatitis B, hepatitis C antibodies, or tuberculosis
- Received any vaccine within the past month
- Received any immunosuppressant therapies in the past
- Received an antibody or therapeutic biologic product in the last 6 months
- Received steroids (other than inhaled) in the past 2 months
- Participated recently in a clinical study
- Current tobacco smokers or has smoked within the last year
- Tested positive for COVID-19 in the past month
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Hammersmith Medicines Research
London
Queen Anne Street Medical Centre
London
Richmond Pharmacology
London
Medicines Evaluation Unit
Manchester
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending-Dose Study to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of UPB-101 in Subjects With Asthma
The goals of this clinical study were to assess the safety, tolerability, blood levels, and disease impact of UPB-101 when given to adults with mild asthma. Eligible participant were consecutively assigned to 1 of 3 to 5 planned treatment groups. Each treatment group consisted of 8 individuals, six of whom will received active drug (UPB-101) and 2 who received placebo. Neither the study doctors nor the participants knew which participants were assigned to active study drug and which were assigned to placebo. The study was performed at 4 experienced research sites in the United Kingdom.
Read the detailed description
This was a two-part phase 1b, multi-center randomized, double-blind (Investigator and Subject blinded; Sponsor unblinded), placebo-controlled, multiple ascending-dose study to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of UPB-101 administered subcutaneously (SC) to adult subjects with asthma.
The study consists of Part A and Part B. Part A included 3 cohorts with pre-set dosing regimens. Part B (optional) included up to 2 additional cohorts whose doses and dosing intervals decided based upon the safety, PK, and PD results from Part A (i.e., an adaptive design), as applicable. The regimens selected for Part B did not exceed the exposures (i.e., doses and/or dosing intervals) included in Part A. Eight subjects were randomized per cohort (6 active, 2 placebo). Thus, a total of 32 subjects were enrolled in the study with 24 subjects in Part A and 8 in Part B.
- Conditions
- Asthma
- Being tested
- UPB-101, Placebo
- Medical subject headings
- Asthma
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
Subcutaneous injection
PlaceboDrug
Also called 0.9% saline solution
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Active substance 1 | Experimental | UPB-101 Cohort 1 Receives: Drug: UPB-101; Drug: Placebo |
| Active substance 2 | Experimental | UPB-101 Cohort 2 Receives: Drug: UPB-101; Drug: Placebo |
| Active substance 3 | Experimental | UPB-101 Cohort 3 Receives: Drug: UPB-101; Drug: Placebo |
| Active Substance 4 | Experimental | UPB-101 Cohort 4 Receives: Drug: UPB-101; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent Adverse Events and Serious Adverse Events
Overall Summary of Treatment-emergent Adverse Events (TEAEs) and Adverse Events (AEs) up to Week 24 (Safety Population)
Measured: Baseline through 24 weeks
Secondary outcomes (4)
Incidence of Anti-drug Antibodies
Blood samples were analyzed for the presence of ADAs using validated assays. Low titer ADA responses were detected toward the end of the concentration vs time profile. There was no evident effect of ADAs on drug exposure and no immune-related adverse events
Measured: Baseline through Week 32
Maximum Observed Concentration of UPB-101
Blood samples were collected and analyzed using a validated assay to determine the Cmax (ug/mL) of UPB-101. The pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.
Measured: First Dose = Day 1. Last Dose = Baseline through 32 weeks.
Time to Maximum Observed Concentration of UPB-101
Blood samples were collected and analyzed using a validated assay to determine the Tmax (days) of UPB-101. The pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.
Measured: Baseline through 32 weeks
Area Under the Concentration-time Curve Under One Dosing Interval of UPB-101
Blood samples were collected and analyzed using a validated assay to determine the AUClast (d.ug/mL) of UPB-101. The pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.
Measured: Baseline through 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start8 Jul 2022
- Primary completion15 Aug 2023
- Study completion5 Oct 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 AsthmaStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Upstream Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sumathi Sivapalasingam, MD, Study director, Upstream Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448651
- Sponsor's protocol ID
- UPB-CP-01
- Status last verified
- Dec 2024
- First submitted
- 29 Jun 2022
- Last updated
- 3 Jan 2025
- 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 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending-Dose Study to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of UPB-101 in Subjects With Asthma
- ClinicalTrials.gov ID
- NCT05448651
- Acronym / sponsor ID
- UPB-CP-01
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Upstream Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Posted 3 Jan 2025
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 were to assess the safety, tolerability, blood levels, and disease impact of UPB-101 when given to adults with mild asthma. Eligible participant were consecutively assigned to 1 of 3 to 5 planned treatment groups. Each treatment group consisted of 8 individuals, six of whom will received active drug (UPB-101) and 2 who received placebo. Neither the study doctors nor the participants knew which participants were assigned to active study drug and which were assigned to placebo. The study was performed at 4 experienced research sites in the United Kingdom.
Detailed description
This was a two-part phase 1b, multi-center randomized, double-blind (Investigator and Subject blinded; Sponsor unblinded), placebo-controlled, multiple ascending-dose study to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of UPB-101 administered subcutaneously (SC) to adult subjects with asthma.
The study consists of Part A and Part B. Part A included 3 cohorts with pre-set dosing regimens. Part B (optional) included up to 2 additional cohorts whose doses and dosing intervals decided based upon the safety, PK, and PD results from Part A (i.e., an adaptive design), as applicable. The regimens selected for Part B did not exceed the exposures (i.e., doses and/or dosing intervals) included in Part A. Eight subjects were randomized per cohort (6 active, 2 placebo). Thus, a total of 32 subjects were enrolled in the study with 24 subjects in Part A and 8 in Part B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active substance 1 | Experimental | Drug: UPB-101, Drug: PlaceboUPB-101 Cohort 1 |
| Active substance 2 | Experimental | Drug: UPB-101, Drug: PlaceboUPB-101 Cohort 2 |
| Active substance 3 | Experimental | Drug: UPB-101, Drug: PlaceboUPB-101 Cohort 3 |
| Active Substance 4 | Experimental | Drug: UPB-101, Drug: PlaceboUPB-101 Cohort 4 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female, aged 18 to 60, and has physician-diagnosed asthma
- Body mass index (BMI) between 18 and 35 kg/m2
- Blood eosinophil cell count ≥200 (OR ≥150 combined with fractional exhaled nitric oxide [a measure of lung airway inflammation] >25) at one screening visit and ≥150 at the other screening
- Agrees to follow the required contraceptive techniques
- Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug
Key exclusion criteria (19 listed)
- Employee, consultant, and/or immediate family member of any person involved in the conduct of the study
- Previous exposure to the study drug or known allergy/sensitivity to any of its ingredients
- Pregnant or breastfeeding female
- Unable to fast and avoid strenuous exercise for 9 hours prior to each site visit
- Serious allergic reaction to any injected drug
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 ASP7266Subcutaneous injection | Drug | Active Substance 4, Active substance 1, Active substance 2, Active substance 3 |
| PlaceboAlso: 0.9% saline solutionSubcutaneous injection | Drug | Active Substance 4, Active substance 1, Active substance 2, Active substance 3 |
Primary outcome
Number of Treatment-emergent Adverse Events and Serious Adverse Events
Time frame: Baseline through 24 weeks
Overall Summary of Treatment-emergent Adverse Events (TEAEs) and Adverse Events (AEs) up to Week 24 (Safety Population)
4 secondary outcomes
Incidence of Anti-drug Antibodies
Time frame: Baseline through Week 32
Maximum Observed Concentration of UPB-101
Time frame: First Dose = Day 1. Last Dose = Baseline through 32 weeks.
Time to Maximum Observed Concentration of UPB-101
Time frame: Baseline through 32 weeks
Area Under the Concentration-time Curve Under One Dosing Interval of UPB-101
Time frame: Baseline through 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- 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.
Sumathi Sivapalasingam, MD study director
Upstream Bio
4 sites 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 Asthma, run by Upstream Bio Inc. at 4 sites 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?
The sponsor lists 7 inclusion and 19 exclusion criteria. 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 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Jan 2025). 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?
Number of Treatment-emergent Adverse Events and Serious Adverse Events (time frame: Baseline through 24 weeks). 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 Jan 2025.