MedTrace Logo

A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D)

NCT03751007 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-02-01

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants with recent-onset type 1 diabetes (T1D).

Conditions

  • Diabetes type1

Interventions

BIOLOGICAL

AG019 - Low Dose

Solid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose)

DRUG

Teplizumab

Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).

DRUG

Placebo-AG019

Formulated identically to AG019 with the active ingredient removed.

DRUG

Placebo-Teplizumab

Formulated identically to teplizumab with the active ingredient removed.

BIOLOGICAL

AG019 - High Dose

Solid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks

BIOLOGICAL

AG019 - High Dose

Solid, orally administered capsule - 6 capsules per day for 8 weeks.

Sponsors & Collaborators

  • Intrexon Actobiotics NV, d/b/a Precigen Actobio

    collaborator UNKNOWN

  • Precigen Actobio T1D, LLC

    lead INDUSTRY

Principal Investigators

  • Chantal Mathieu, MD · University Hospital of Leuven, Clinical and Experimental Endocrinology

  • Kevan Herold, MD · Yale Center for Clinical Investigation; Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2021-10-13
Completion
2021-10-13
FDA Drug
Yes

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

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 NCT03751007 on ClinicalTrials.gov