Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Oral Administration of AIM-102 in Patients With Mild to Moderate Allergic Asthma

NCT01501942 | Completed Phase 2

• 1 other identifier: AIM102-201
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase II, double-blind, placebo-controlled, cross-over trial to evaluate the efficacy of AIM-102 for the treatment of allergen-induced asthma. Individuals with stable, mild to moderate allergic asthma by American Thoracic Society (ATS) criteria (1), with a history of episodic wheeze and shortness of breath, will be eligible for enrollment. The patients will receive 4 consecutive days of dosing of AIM-102 or placebo (inactive product) with an allergen challenge on day 3 of dosing to see how the patient's lung function is changed by using AIM-102 or placebo.

Conditions

Asthma

Keywords

Asthma; Allergen induced asthma; ATS Criteria (1)

Outcome Measures

Primary Outcomes (1)

• Change from baseline of the allergen-induced late asthmatic response (LAR) between AIM-102 and placebo.

  Spirometry and the presence and severity of asthma symptoms will be assessed immediately before and immediately after each dose. Baseline and allergen-induced methacholine PC20, allergen-induced bronchoconstriction and allergen-induced airway inflammation will be assessed. AUC and maximum decrease in FEV1 for the late response will be compared between treatments using a one-way analysis of variance for the effects of treatment.

  Pre dose(s) and post dose(s) and 7 and 24 hours post allergen challenge

Secondary Outcomes (5)

• Early Asthmatic Response

  Pre-dose(s) and post-dose(s) and 3 hours after allergen challenge

• • Comparison of the allergen-induced changes in sputum eosinophils at 7 hr and 24 hr post allergen, between the AIM-102 and placebo

  Pre-dose and post-dose(s) and 7 and 24 hours post allergen challenge

• Comparison of allergen-induced inflammatory mediators at 7 hr and 24 hr post allergen, between AIM-102 and placebo.

  Pre-dose and post-dose(s) and 7 and 24 hours post allergen challenge

• Comparison of the allergen-induced airway hyperresponsiveness at 24 hours (hr) post allergen, between AIM-102 and placebo

  Pre-dose and 24 hours post allergen challenge

• To determine the pharmacokinetic (PK) profile of AIM-102 in normal healthy mild to moderate asthmatic patients upon repeat dosing of AIM-102

  Pre-dose for dosing Days 1, 2, 3, 4, & an optional Day 5, additional samples on Day 3 post-dose & allergen challenge,pre-dose, 1.5, 3, 4.5, 6, & 7.5 hr post-dose

Study Arms (2)

Active

EXPERIMENTAL

The active drug product is an oral solution of AIM-102 in phosphate buffered saline at a concentration of 35.0 mg/ml.

Drug: AIM-102, D-cyclohexylalanine-D-glutamic-glycine tripeptide

Inactive product

PLACEBO COMPARATOR

The matching placebo is an oral solution of phosphate buffered saline

Drug: Buffered Saline

Interventions

AIM-102, D-cyclohexylalanine-D-glutamic-glycine tripeptide DRUG

AIM-102 is supplied as an oral solution. Dose is 15 mg of AIM-102 per kg of patient weight measured on Treatment Day 1 of each treatment phase The study drug will be administered for 4 consecutive days with at least a 2 week wash-out period prior to crossing over to the alternative treatment for 4 days.

Active

Buffered Saline DRUG

The matching placebo is an oral solution of phosphate buffered saline

Inactive product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between ≥ 18 and ≤ 65 years of age.
• Able and willing to provide written informed consent to participate in the study, in accordance with ICH GCP requirements.
• Non or ex-smoker, defined by an ex-smoker is defined as someone who completely stopped smoking for at least 12 months before Visit 1 of this study.
• Able to adhere to study procedures.

You may not qualify if:

• Physical examination and laboratory results within the normal ranges, if not within the ranges, they must be without clinically significance within 28 days prior to dosing.
• Available for follow-up for the duration of the study (i.e. up to 10 weeks, including the Screening and Treatment Phases).
• Mild to moderate, stable, allergic asthma by the ATS criteria (1)
• History of episodic wheeze and shortness of breath; FEV1 at baseline at least 70% of the predicted value
• Males agree to practice adequate contraception throughout the duration of the study and up to one month after drug administration.
• All females must have a negative serum pregnancy test at Screening Days -5 to -1 (Visit 5) and a negative urine pregnancy test at Day 1 of each Treatment Phase prior to dosing (Visits 6 and 11).
• A female patient must meet one of the following criteria:
• No reproductive potential, defined as: menopausal for at least two years or surgically sterile for at least six months (i.e. has undergone hysterectomy, bilateral oophorectomy or tubal ligation) OR
• Participant agrees to be heterosexually inactive from Screening Visit 1 until one month post final dose OR
• Participant agrees to consistently practice adequate contraception from Screening Visit 1 until one month post final dose by one of the following methods, two methods must be used if hormonal contraception is used: Contraceptive pills (stable dose for at least 2 months prior to dosing on Day 1 (Visit 6) or patch, Norplant or Provera; intrauterine device (IUD), condom with spermicide or diaphragm (cervical cap) with spermicide.
• Positive methacholine challenge (PC20 ≤ 16 mg/ml)
• Positive skin-prick test to common aeroallergens (including cat, dust mite, grass, pollen)
• Positive allergen-induced early and late airway bronchoconstriction
• A patient will be excluded if one or more of the following conditions apply.
• Females who are pregnant or are lactating

Sponsors & Collaborators

• AIM Therapeutics Inc.: lead

Study Sites (2)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Institut de cardiologie et de pneumologie de l'Hôpital Laval

Laval, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Paul O'Byrne, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2011
• First Posted: December 30, 2011
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

CA (2)