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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04728711
Other study ID # ADX-629-AA-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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