The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy.
This is a first-in-human trial of this live biotherapeutic product. The primary objective is to assess safety and tolerability in allergic subjects who are otherwise healthy, with twice daily dosing in descending age groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Bensch Clinical Research LLC
Stockton, California, United States
RECRUITINGOrange County Research Center
Tustin, California, United States
RECRUITINGNumber of patients with treatment-related adverse events (AEs) assessed as mild, moderate and severe, from baseline to day 29.
All adverse events (AEs) recorded during the study through the date of randomization up to 28 days after the last dose of study drug will analyzed. Treatment-emergent AEs (TEAEs), defined as any AE that starts or increases in severity after the first dose of STMC-103H or placebo, will be summarized. The total number of reported AEs will also be summarized.
Time frame: From baseline to day 57
Incidence of abnormal laboratory test results from baseline to day 29
The change in laboratory results from baseline to day 29 in multi-sensitized (to two or more allergens) subjects who are otherwise healthy and who have completed BID dosing of STMC-103H or placebo for 28 days
Time frame: From baseline to day 29
Change in blood pressure from baseline to day 57
Observed values of blood pressure obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit.
Time frame: From baseline to day 57
Change in respiration rate from baseline to day 57
Observed values of respiration rate obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit.
Time frame: From baseline to day 57
Change in heart rate from baseline to day 57
Observed values of heart rate obtained at screening and study Days 1, 8, 15, 22, 29, 43, and 57) and corresponding changes from baseline (Day 1) will be listed and summarized by descriptive statistics by study part and visit.
Time frame: From baseline to day 57
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