A Phase 1b, Multi-centered, Randomized, Double-blind, Placebo-controlled, Parallel Group, Three Sequential Part Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Number of patients with treatment-related adverse events (AEs) assessed as mild, moderate and severe, from baseline to day 29.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 2 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary informed consent from subject or legally acceptable representative and/or child assent from the subject (as applicable).
- •For part 1, subjects of 18 years to 40 years of age at the timing of the signature on the informed consent.
- •For part 2, subjects of 12 years to 17 years of age at the timing of the signature on the informed consent.
- •For part 3, subjects of 2 years to 11 years of age at the timing of the signature on the informed consent.
- •Good health and free of significant diseases or clinically significant abnormal findings on physical exam and laboratory evaluations.
- •No history or presence of gastrointestinal, hepatic, or renal disease/disorder.
- •History of allergic disease confirmed by 2 or more episodes in past 5 years.
- •Positive skin prick test to two or more common allergens.
- •Subjects who are of childbearing potential must agree to remain abstinent from heterosexual activity or agree to use (or have their partner use) acceptable contraception to prevent pregnancy within projected duration of the trial.
排除标准
- •Presence or history of any significant acute or chronic medical illness, except for allergic disease.
- •BMI > 32 kg/m2 at the time of signing consent.
- •Current or persistent moderate to sever asthma that requires use of control medication (Step 3 or above, according to Asthma Step Program).
- •Presence of rhinitis secondary to causes other than allergy.
- •History of anaphylaxis.
- •Any known allergies to two or more of the following three antibiotics: Augmentin, tetracycline, or bacitracin.
- •Inability to be venipunctured and/or tolerate venous access (Parts 1 and 2 only).
- •Consistent consumption of probiotics ≥ 2 days / week over multiple weeks within the 3 months prior to the study Baseline Visit.
- •Regular use of any of the following medications:
- •Intranasal or systemic corticosteroids (in 1 month prior to screening or during study)
- •Leukotriene modifiers (in 1 month prior to screening or during study)
- •Intranasal cromolyn (in 2 weeks prior to screening or during study)
- •Intranasal or systemic decongestants (in 3 days prior to screening or during study)
- •Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine (in 10 days prior to screening or during study)
- •Intranasal antihistamines (in 3 days prior to screening or during study)
- •Other systemic antihistamines (in 3 days prior to screening or during study)
- •Allergies to excipients in the Investigational Product formulation.
- •Allergy to soy in any form.
- •Presently consuming alcohol more than 2 glasses per day or has history of alcohol dependence or alcohol abuse during the past one year prior to screening.
- •Presently a smoker or ex-smoker with history of smoking (subject must abstain from smoking throughout the study).
- •History or presence of significant recreational or illicit drug abuse in past 1 year.
- •Participation in another clinical study within 30 days prior to screening.
- •Use of any probiotic or prebiotic in the past 3 months prior to screening.
研究组 & 干预措施
STMC-103H
Oral administration of STMC-103H twice daily, randomized 3:1 (STMC-103H:Placebo) in three age-descending groups:
Part 1: 20 subjects 18-40 years of age Part 2: 20 subjects, 12-17 years of age Part 3: 20 subjects, 2-11 years of age
干预措施: STMC-103H (Biological)
Placebo
Oral administration of placebo twice daily, randomized 3:1 (STMC-103H:Placebo) in three age-descending groups:
Part 1: 20 subjects 18-40 years of age Part 2: 20 subjects, 12-17 years of age Part 3: 20 subjects, 2-11 years of age
干预措施: Placebo (Biological)
结局指标
主要结局
Number of patients with treatment-related adverse events (AEs) assessed as mild, moderate and severe, from baseline to day 29.
时间窗: From baseline to day 57
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.
Incidence of abnormal laboratory test results from baseline to day 29
时间窗: 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
Change in respiration rate from baseline to day 57
时间窗: 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.
Change in heart rate from baseline to day 57
时间窗: 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.
Change in blood pressure from baseline to day 57
时间窗: 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.
次要结局
未报告次要终点