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A Multiple Ascending Dose Study of CAT-1004 in Patients With Type 2 Diabetes

NCT01511900 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-06-08

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety of escalating multiple doses over 2 weeks of CAT 1004 compared to placebo in patients with Type 2 diabetes (T2D).

Secondary objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics of escalating multiple doses of CAT-1004 in patients with T2D.

Conditions

Interventions

DRUG

CAT 1004

Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 1-9 subjects will be treated with CAT-1004

DRUG

Placebo

Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort

DRUG

CAT 1004

Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 2 -9 subjects will be treated with CAT-1004

DRUG

CAT 1004

Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 3-9 subjects will be treated with CAT-1004

DRUG

CAT 1004

Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 4-9 subjects will be treated with CAT-1004

DRUG

CAT 1004

Multiple dose oral administration daily for 14 days of CAT 1004 at dose level TBD-9 subjects will be treated with CAT-1004

Sponsors & Collaborators

  • Catabasis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joanne Donovan, M.D., PhD · Catabasis

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01511900 on ClinicalTrials.gov