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)

NCT ID: NCT04728711

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-09
• Study Completion Date: 2022-01-18

Brief 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)

Conditions

Atopic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

ADX-629

Intervention Type: DRUG

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

Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week

Interventions

ADX-629

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

Intervention Type: DRUG

Placebo

Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aldeyra Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cliantha Research

Mississauga, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ADX-629-AA-001

Identifier Type: -

Identifier Source: org_study_id