Phase 1
Completed N=32
Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in Asthmatics
Source: ClinicalTrials.gov NCT05448651 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Number of Treatment-emergent Adverse Events and Serious Adverse Events — 19; 17; 12; 9 adverse events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment-emergent Adverse Events and Serious Adverse Events |
19; 17; 12; 9; 25; 0 | — |
| SECONDARY Incidence of Anti-drug Antibodies |
4; 5; 1; 2; 0 | — |
| SECONDARY Maximum Observed Concentration of UPB-101 |
8.82; 21.8; 32.4; 1.85; 16.3; 41.8 | — |
| SECONDARY Time to Maximum Observed Concentration of UPB-101 |
6.98; 5.95; 6.93; 9.94; 5.00; 3.94 | — |
| SECONDARY Area Under the Concentration-time Curve Under One Dosing Interval of UPB-101 |
187; 449; 1220; 73.4; 613; 1740 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT05448651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.