Current partner codePEPTIDESDE
NCT00868660·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

66

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full detailed description

A 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

Interventions

Treatment arms and agents.

DRUG

ZP1848

sc. bolus

Timeline

From registration to results.

  1. First posted

    Mar 25, 2009

  2. Study start

    Jan 2009

  3. Primary completion

    Feb 2010

  4. Study completion

    Feb 2010

  5. Results posted

    Not reported

  6. Registry updated

    Nov 2, 2010

Outcomes

What the study measures.

Primary outcomes

safety and tolerability

Time frame · January2009-January2010

Secondary outcomes

Pharmacokinetics

Time frame · Jan 2009 - Jan 2010

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
60 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Healthy adult male and/or females, 18 to 50 years of age * Body mass index (BMI)18-30. Chrons Inclusion * Adult male and/or females, 18 to 60 years of age (inclusive). * Body mass index (BMI) ≥ 18 and ≤ 30 (kg/m2). * Crohn's Disease Activity Index (CDAI) score \< 150. * In a stable state of Crohn's disease as per the Investigator's opinion. * Free of steroid treatment (therapy targeted for the GI tract only) within the 3 months prior to Day 1. Exclusion Criteria: * History or presence of dysplasia, cancer, chronic hepatitis, HIV, tuberculosis (TB), or histoplasmosis. * Fistula within the 3 months prior to dosing. 3. Ostomy (having ostomy now or at any time in the past). 4. Any surgery for the treatment of inflammatory bowel disease (IBD) within the 3 months prior to Day 1. 5. Short Bowel Syndrome (SBS). 6. Any other condition, chronic disease, or prior therapy, which in the opinion of the Investigator/Investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

CRI Worldwide

Willingboro, New Jersey, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.