Trials / Withdrawn
WithdrawnNCT01304628
Cross-Over Study of Subcutaneous Study Drug for the Treatment of Patients With Mild to Moderate Asthma
A Phase 2a, Double-Blinded, Multi-Center, Escalating Dose Group, Placebo Controlled, Cross-Over Study to Evaluate the Safety, Efficacy and Tolerability of Subcutaneously Administered PL-3994 for the Treatment of Patients With Mild to Moderate Asthma
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Palatin Technologies, Inc · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | PL-3994 | subcutaneous PL-3994, single dose, 4 escalating dose groups |
Timeline
- First posted
- 2011-02-25
- Last updated
- 2014-12-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01304628. Inclusion in this directory is not an endorsement.