Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in Asthmatics

NCT05448651 | Completed Phase 1 Results

• 1 other identifier: UPB-CP-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline through 24 weeks

Secondary Outcomes (4)

• Incidence of Anti-drug Antibodies

  Baseline through Week 32

• Maximum Observed Concentration of UPB-101

  First Dose = Day 1. Last Dose = Baseline through 32 weeks.

• Time to Maximum Observed Concentration of UPB-101

  Baseline through 32 weeks

• Area Under the Concentration-time Curve Under One Dosing Interval of UPB-101

  Baseline through 32 weeks

Study Arms (4)

Active substance 1

EXPERIMENTAL

UPB-101 Cohort 1

Drug: UPB-101; Drug: Placebo

Active substance 2

EXPERIMENTAL

UPB-101 Cohort 2

Drug: UPB-101; Drug: Placebo

Active substance 3

EXPERIMENTAL

UPB-101 Cohort 3

Drug: UPB-101; Drug: Placebo

Active Substance 4

EXPERIMENTAL

UPB-101 Cohort 4

Drug: UPB-101; Drug: Placebo

Interventions

UPB-101 DRUG

Subcutaneous injection

Also known as: Formerly ASP7266

Active Substance 4; Active substance 1; Active substance 2; Active substance 3

Placebo DRUG

Subcutaneous injection

Also known as: 0.9% saline solution

Active Substance 4; Active substance 1; Active substance 2; Active substance 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Upstream Bio Inc.: lead

Study Sites (4)

Hammersmith Medicines Research

London, United Kingdom

Location

Queen Anne Street Medical Centre

London, United Kingdom

Location

Richmond Pharmacology

London, United Kingdom

Location

Medicines Evaluation Unit

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

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

sumathi.sivapalasingam@upstreambio.com

917-499-0789

Study Officials

• Sumathi Sivapalasingam, MD

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 7, 2022
• Study Start: July 8, 2022
• Primary Completion: August 15, 2023
• Study Completion: October 5, 2023
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)