Study to Assess PK, Safety and Tolerability in Patients With DM and CKD

NCT03795389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-09-13

No results posted yet for this study

Summary

An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease. The primary objectives of this study are to evaluate safety, tolerability, and PK profile of DM199 in these subjects.

Conditions

Interventions

DRUG

DM199

Single SC dose

Sponsors & Collaborators

  • DiaMedica Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Harry Alcorn, Pharm.D. · DiaMedica Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2019-07-21
Completion
2019-07-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03795389 on ClinicalTrials.gov