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NCT03751007COMPLETEDanonymous

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)

Sponsor

Source record

Precigen Actobio T1D, LLC

Phase

Source record

Phase 1b/2a

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Type 1 Diabetes (T1D)

Indication / condition

AI-normalized

Diabetes type1

Intervention

Source record

AG019 - Low Dose, Teplizumab, Placebo-AG019, Placebo-Teplizumab, AG019 - High Dose, AG019 - High Dose

Source & freshness

Source record

NCT ID

NCT03751007

Original source

ClinicalTrials.gov

Source last updated

Feb 01, 2023

Ingested at

May 31, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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NCT ID

NCT03751007

Title

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)

Sponsor

Precigen Actobio T1D, LLC

Status

COMPLETED

Phase

Phase 1b/2a

Condition raw

Diabetes type1

Condition normalized

Diabetes type1

Modality raw

Diabetes type1

Modality normalized

monoclonal antibody

Target raw

Type 1 Diabetes (T1D)

Target normalized

Type 1 Diabetes (T1D)

Interventions

AG019 - Low Dose, Teplizumab, Placebo-AG019, Placebo-Teplizumab, AG019 - High Dose, AG019 - High Dose

Public preview

Source record

The clinical trial assessed the safety and tolerability of AG019, both as a monotherapy and in combination with Teplizumab, in patients with recent-onset Type 1 Diabetes. Conducted by Precigen Actobio T1D, LLC, the study aimed to evaluate different dosing regimens across two age groups (12-17 and 18-40 years).

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