A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)

Atopic Asthma Clinical Trial

Official title:

A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04728711
• Other study ID #: ADX-629-AA-001
• Status: Completed
• Phase: Phase 2
• Start date: January 9, 2021
• Est. completion date: January 18, 2022

Study information

• Verified date: January 2023
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects with Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or non-pregnant female, between 18 to 65 years of age (inclusive) at Screening Visit.

• Subjects must give their signed and dated written informed consent (in English) to participate prior to commencing any study-related activities and must be willing to comply with study procedures, study restrictions, study protocol, and return for the required assessments.

• Female subjects of either non-childbearing potential or of child-bearing potential who commit to consistent and correct use of at least one highly effective or two effective forms of contraception starting at least 4 weeks prior to the Screening Visit and for at least 30 days post last dose of study drug.

• Generally healthy subjects with mild controlled asthma for 2 years at Screening Visit according to the Global Initiative for Asthma criteria.

Exclusion Criteria:

• History and presence of clinically significant cardiovascular, renal, neurologic, hepatologic, endocrinologic, gastrointestinal, genitourinary, autoimmune, hematological, or metabolic disease other than asthma, which in the opinion of Investigator may either put the subject at risk or influence the results during the study.

• Positive skin prick test to other perennial allergens (i.e., mold, dog with = 3 mm wheal compared to negative control). Subjects with seasonal allergy symptoms that occur or are anticipated to occur during the study should result in subject exclusion or rescheduling until the subject is out of the allergy season.

• Any relevant pulmonary disease within 1 year prior to dosing at the discretion of the investigator.

• Recent hospitalization with asthma in the last 6 months or any other medical condition that the Investigator deems incompatible with participation in the trial.

Related Conditions & MeSH terms

• Asthma
• Atopic Asthma

Intervention

Drug:
• ADX-629
ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week
• Placebo
Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week

Locations

Country	Name	City	State
Canada	Cliantha Research	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of ADX-629 in subjects with allergen-induced mild asthma	Safety, as assessed by adverse events (AEs) and serious adverse events (SAEs)	Safety assessment period (Day 1 through Day 75)