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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
History of Changes
  Purpose

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


Condition Intervention Phase
Crohns Disease
 Drug: ZP1848
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by MDS Pharma Services:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
Enrollment: 60
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Level 1
Single Ascending Dose - Healthy Normal
 Drug: ZP1848
Safety and Tolerability
Experimental: Dose Level 2
Single Ascending Dose - Healthy Normal
 Drug: ZP1848
Safety and Tolerability
Experimental: Dose Level 3
Single Ascending Dose - Healthy Normal
 Drug: ZP1848
Safety and Tolerability
Experimental: Dose Level 4
Single Ascending Dose - Healthy Normal
 Drug: ZP1848
Safety and Tolerability
Experimental: Dose Level 5
Single Ascending Dose - Healthy Normal
 Drug: ZP1848
Safety and Tolerability
Experimental: Dose Level 6
Single Ascending Dose - Healthy Normal
 Drug: ZP1848
Safety and Tolerability
Experimental: Dose Level 7
Single Ascending Dose - Healthy Normal
 Drug: ZP1848
Safety and Tolerability
Experimental: Placebo
Single Ascending Dose - Healthy Normal
 Drug: ZP1848
Safety and Tolerability

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429922

Locations
United States, New Jersey
MDS Pharma Services
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
MDS Pharma Services
Investigators
Principal Investigator: Sandra M Connolly, MD MDS Pharma Services
Principal Investigator: Howard Hassman, DO CRI Worldwide - Lourdes Inpatient Center
  More Information

No publications provided

Responsible Party: MDS Pharma Services
ClinicalTrials.gov Identifier: NCT01429922     History of Changes
Obsolete Identifiers: NCT00868660
Other Study ID Numbers: ZP08-216
Study First Received: August 29, 2011
Last Updated: September 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
 Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on March 03, 2015