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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01429922
• Date of registration: 29/08/2011
• Prospective Registration: No
• Primary sponsor: MDS Pharma Services
• Public title: Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
• Scientific 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
• Date of first enrolment: January 2009
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01429922
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Sandra M Connolly, MD
• Affiliation: MDS Pharma Services

• Name: Howard Hassman, DO
• Affiliation: CRI Worldwide - Lourdes Inpatient Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohns Disease

Intervention(s)

Drug: ZP1848

Primary Outcome(s)

Safety and Tolerance [Time Frame: 6.5 days.]

Secondary Outcome(s)

T max [Time Frame: Up to 48 hours post-dose]

AUC [Time Frame: Up to 48 hours post-dose]

C Max [Time Frame: Up to 48 hours post-dose]

Secondary ID(s)

ZP08-216

Source(s) of Monetary Support

Please refer to primary and secondary sponsors