Cross-Over Study of Subcutaneous Study Drug for the Treatment of Patients With Mild to Moderate Asthma

NCT01304628 | Withdrawn Phase 2

• 1 other identifier: PL-3994-501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate if single subcutaneous (SC) doses of PL-3994, administered to patients with asthma can achieve a clinically meaningful increase in pulmonary function (Forced Expiratory Volume in one second: FEV1) while maintaining an acceptable safety profile. The study will characterize the bronchodilator effect, dose and safety of PL-3994 in a population of moderately severe, stable asthmatics following overnight withdrawal of beta-2 agonists.

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• Change in Forced Expiratory Volume in one second (FEV1)

  Serial spirometry measures, including FEV1, assessed at specified time periods over 12 hours post dose.

  Throughout 12 hours post dosing

Secondary Outcomes (1)

• Change in Forced Vital Capacity (FVC)

  Throughout 12 hours post dosing

Study Arms (2)

PL-3994 (4 escalating doses)

EXPERIMENTAL

Drug: PL-3994

Placebo

PLACEBO COMPARATOR

Drug: PL-3994

Interventions

PL-3994 DRUG

subcutaneous PL-3994, single dose, 4 escalating dose groups

PL-3994 (4 escalating doses); Placebo

Eligibility Criteria

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

You may qualify if:

• Subject has provided written informed consent
• The subject is male or female \>18 to 65 years of age
• Patient has a clinical history of asthma as defined by the National Asthma Education and Prevention Program.
• Documented bronchodilator response to albuterol as defined by the American Thoracic Society (\> 200 mL and \> 12% increase in FEV1 after bronchodilator inhalation)
• FEV1 post-bronchodilator of between 55% and 80% predicted.
• Currently taking 200-1000 mcg (fluticasone equivalent) of inhaled corticosteroids
• If the subject or subject's partner is of child-bearing potential, a medically acceptable form of contraception will be used for three months prior to the screening visit (females only), for the duration of the study and for one month following the last dose of the study drug. Medically acceptable contraceptives include: (1) surgical sterilization, (2) FDA-approved female hormonal contraceptives, (3) an intrauterine device (IUD), (4) condoms with spermicide, or (5) diaphragm with spermicide.
• If the subject had a vasectomy greater than 6 months prior to the screen visit, this will also be acceptable.

You may not qualify if:

• Current diagnosis, as per subject or investigator or screening assessment, of:
• unstable or uncontrolled disease in any organ system (including cardiovascular) on present therapy
• psychiatric disease requiring daily medication, including controlled or uncontrolled schizophrenia or any other uncontrolled psychiatric condition
• significant neurological disease
• current or history of any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to screening
• acute or chronic disease requiring frequent changes in medications or changes in dosages of chronic therapy
• history of alcohol abuse within the past 5 years
• positive result for the alcohol and/or drug tests at screening or check-in
• positive for HIV, or Hep B\&C at screening
• blood donation within 30 days of screening or plasma donation within 7 days of screening
• weight \> 100 kg or \< 50 kg
• clinically significant electrocardiogram (ECG) at screening
• any clinically significant (per the investigator) lab abnormalities
• any fever or other clinically significant physical exam abnormalities
• History of COPD or any other lung disease

Sponsors & Collaborators

• Palatin Technologies, Inc: lead

Study Sites (1)

Unknown Facility

Cranbury, New Jersey, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

PL-3994

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: February 25, 2011
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

US (1)