NCT03751007

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)

A Prospective, Multi-center, Phase 1b/2a Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Association With Teplizumab in Patients With Clinical Recent-onset Type 1 Diabetes Mellitus (T1D)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Precigen Actobio T1D, LLC · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This Phase 1b/2a, multi-center study will be conducted in participants with clinical recent-onset type 1 diabetes (T1D). The primary objective of this study is to assess the safety and tolerability of different doses of AG019 alone as well as AG019 in combination with teplizumab. The secondary objectives of this study are: to obtain pharmacodynamic (PD) data of AG019 alone as well as AG019 in combination with teplizumab; and to determine the potential presence of AG019 in systemic circulation (safety - systemic exposure) and the presence of L. lactis bacteria in fecal excretion (local exposure): Pharmacokinetic (PK) profile. This study consists of 2 phases: Phase 1b: this open-label part of the study will investigate the safety and tolerability of 2 different doses of AG019 in 2 age groups (18-40 years of age and 12-17 years of age). Phase 2a: this randomized, double-blind part of the study will investigate the safety and tolerability of AG019, in combination with teplizumab, in 2 age groups (18-40 years of age and 12-17 years of age).

Conditions

• Diabetes type1

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-24
• Primary completion: 2021-10-13
• Completion: 2021-10-13
• First posted: 2018-11-23
• Last updated: 2023-02-01
• Results posted: 2023-02-01

Locations

18 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated drug study