NCT01689831

Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)

Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: JHP Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).

Detailed description

JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.

Conditions

• Tuberculosis Infection

Interventions

Type	Name	Description
BIOLOGICAL	To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.	Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
BIOLOGICAL	Reactivity of Aplisol compared to reference standard PPD-S2.	Reference standard PPD-S2 formulated to contain different dose concentrations.

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2012-09-21
• Last updated: 2012-09-21

Locations

1 site across 1 country: United States