This is 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 includes 3 cohorts with pre-set dosing regimens. Part B (optional) includes up to 2 additional cohorts whose doses and dosing intervals will be 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 will not exceed the exposures (i.e., doses and/or dosing intervals) included in Part A. Eight subjects will be randomized per cohort (6 active, 2 placebo). Thus, a total of approximately 24 to 40 subjects will be enrolled in the study with 24 subjects in Part A and up to 16 if Part B cohorts are implemented.
The goals of this clinical study are to assess the safety, tolerability, blood levels, and disease impact of UPB-101 when given to adults with mild asthma. Eligible participant will be consecutively assigned to 1 of 3 to 5 planned treatment groups. Each treatment group will consist of 8 individuals, six of whom will receive active drug (UPB-101) and 2 who will be given placebo. Neither the study doctors nor the participants will know which participants were assigned to active study drug and which were assigned to placebo. The study will be performed at 3-4 experienced research sites in the United Kingdom.