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UPB-101

Phase 1

Asthma | Small molecule | Respiratory |Upstream Bio, Inc.|Last Updated: Jan 3, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

UPB-101 · 2 trials · 2 indications

Phase 1 2
NCT05653479Safety and Blood Levels After a Single Injection of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian AdultsHealthy
COMPLETED32 Analytics
NCT05448651Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in AsthmaticsAsthma
COMPLETED32 Analytics
PHASE1COMPLETED
Safety and Blood Levels After a Single Injection of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults
HealthyUnlock trial analytics
PHASE1COMPLETED
Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in Asthmatics
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Concentration (Cmax) of UPB-101
Baseline through Day 85

Non-compartmental analysis was used for estimation of PK parameters.

Time to Maximum Observed Concentration (Tmax) of UPB-101
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)
Baseline through Day 85

Non-compartmental analysis was used for estimation of PK parameters. AUC = Area under the concentration-time curve

Number of Treatment-emergent Adverse Events and Serious Adverse Events
Baseline through 24 weeks

Overall Summary of Treatment-emergent Adverse Events (TEAEs) and Adverse Events (AEs) up to Week 24 (Safety Population)

Secondary Endpoints

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
Incidence of Anti-drug Antibodies
Baseline through Week 32
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Group 1EXPERIMENTALSingle subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
Treatment Group 2EXPERIMENTALSingle subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
Treatment Group 3EXPERIMENTALSingle subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
Treatment Group 4EXPERIMENTALSingle subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants
Active substance 1EXPERIMENTALUPB-101 Cohort 1
Active substance 2EXPERIMENTALUPB-101 Cohort 2
Active substance 3EXPERIMENTALUPB-101 Cohort 3
Active Substance 4EXPERIMENTALUPB-101 Cohort 4

Interventions

NameTypeDescription
UPB-101DRUGUPB-101 Subcutaneous injection
PlaceboDRUGSubcutaneous injection
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United Kingdom
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Frequently asked questions about UPB-101

What is UPB-101 used for?

UPB-101 is an investigational small molecule being studied for the treatment of asthma. It is currently in Phase 1 clinical development, with completed trials evaluating its safety and biologic impact in asthmatics. The drug is not yet approved and remains under investigation.

Who is developing UPB-101?

UPB-101 is being developed by Upstream Bio, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and pharmacodynamics in patients with asthma and in healthy volunteers.

What phase is UPB-101 in?

UPB-101 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in asthmatics and one in healthy adults. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has UPB-101 been in?

UPB-101 has been studied in two completed Phase 1 trials. NCT05448651 evaluated repeated injections and increasing doses in asthmatics, while NCT05653479 assessed a single injection in healthy Japanese and non-Japanese non-East Asian adults. Both trials were conducted in the United Kingdom.

Is UPB-101 the same as any other drug?

UPB-101 is the primary name used for this investigational drug. No alternative names have been reported in clinical trial records, and it is not known to be identical to any other approved or investigational medication.