Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MDS Pharma Services
ClinicalTrials.gov Identifier:
NCT01429922
First received: August 29, 2011
Last updated: September 19, 2011
Last verified: September 2011

August 29, 2011
September 19, 2011
January 2009
August 2009   (final data collection date for primary outcome measure)
Safety and Tolerance [ Time Frame: 6.5 days. ] [ Designated as safety issue: Yes ]
The safety assessments consisted of vital signs, physical examinations, 12-lead safety ECGs, Holter ECGs, clinical laboratory evaluations, adverse events (AEs), respiratory assessments, and neurological examinations.
Same as current
Complete list of historical versions of study NCT01429922 on ClinicalTrials.gov Archive Site
  • T max [ Time Frame: Up to 48 hours post-dose ] [ Designated as safety issue: No ]
    1. To assess the pharmacokinetics (PK) of ZP1848 following single bolus sc injections administered to healthy adult subjects.
    2. To assess the PK of ZP1848 following single and multiple sc bolus injections, with up to 2 dose levels per patient, administered to adult patients with stable Crohn's disease in remission.
  • C Max [ Time Frame: Up to 48 hours post-dose ] [ Designated as safety issue: No ]
    1. To assess the pharmacokinetics (PK) of ZP1848 following single bolus sc injections administered to healthy adult subjects.
    2. To assess the PK of ZP1848 following single and multiple sc bolus injections, with up to 2 dose levels per patient, administered to adult patients with stable Crohn's disease in remission.
  • AUC [ Time Frame: Up to 48 hours post-dose ] [ Designated as safety issue: No ]
    1. To assess the pharmacokinetics (PK) of ZP1848 following single bolus sc injections administered to healthy adult subjects.
    2. To assess the PK of ZP1848 following single and multiple sc bolus injections, with up to 2 dose levels per patient, administered to adult patients with stable Crohn's disease in remission.
Same as current
Not Provided
Not Provided
 
Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
Double Blind Placebo-controlled,Safety and Tolerability of ZP1848 Administered as Ascending Single Dose SUBCUTANEOUS Bolus Injections in Healthy Subjects Followed by Multiple Dose Cohort of Patients With Stable Crohn's Disease in Remission

Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose.

Phase I, Double blind, Placebo-controlled, safety and tolerability study of ZP1848 administered as Ascending single Dose, SUBCUTANEOUS bolus injections in healthy SUBJECTS followed by a Multiple Dose cohort of patients with stable Crohn's disease in remission.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Crohns Disease
Drug: ZP1848
Safety and Tolerability
  • Experimental: Dose Level 1
    Single Ascending Dose - Healthy Normal
    Intervention: Drug: ZP1848
  • Experimental: Dose Level 2
    Single Ascending Dose - Healthy Normal
    Intervention: Drug: ZP1848
  • Experimental: Dose Level 3
    Single Ascending Dose - Healthy Normal
    Intervention: Drug: ZP1848
  • Experimental: Dose Level 4
    Single Ascending Dose - Healthy Normal
    Intervention: Drug: ZP1848
  • Experimental: Dose Level 5
    Single Ascending Dose - Healthy Normal
    Intervention: Drug: ZP1848
  • Experimental: Dose Level 6
    Single Ascending Dose - Healthy Normal
    Intervention: Drug: ZP1848
  • Experimental: Dose Level 7
    Single Ascending Dose - Healthy Normal
    Intervention: Drug: ZP1848
  • Experimental: Placebo
    Single Ascending Dose - Healthy Normal
    Intervention: Drug: ZP1848
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2010
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy adult subjects
  2. Patients with stable Crohn's disease in remission and a Crohn's Disease Activity Index (CDAI) score of < 150
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01429922
ZP08-216
Yes
MDS Pharma Services
MDS Pharma Services
Not Provided
Principal Investigator: Sandra M Connolly, MD MDS Pharma Services
Principal Investigator: Howard Hassman, DO CRI Worldwide - Lourdes Inpatient Center
MDS Pharma Services
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP