MedTrace Logo

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

NCT01304628 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-12-16

No results posted yet for this study

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

Interventions

DRUG

PL-3994

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

Sponsors & Collaborators

  • Palatin Technologies, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01304628 on ClinicalTrials.gov