Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients

Genexine, Inc.8 enrolled

Overview

This study is designed as a combination of phase 1 (Part A) and phase 2 (Part B). The purpose of Part A was to determine the safety, tolerability, and pharmacokinetics in patients with total thyroidectomy or near total thyroidectomy of GX-30 and it has been completed. The Part B is currently recruiting and will investigate the efficacy and safety of GX-30 compared with THYROGEN®.

Recombinant human TSH was developed to provide TSH stimulation without withdrawal of thyroid hormone. Radioiodine ablation and diagnosis with rhTSH became the standard of care treatment for patients with differentiated thyroid cancer. Stably supplying rhTSH has been the unmet need for management and follow-up procedure for thyroid remnant. GX-30 is an investigational product, developed to provide inexpensive rhTSH to patients in order to ensure stable supply of rhTSH.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Total Thyroidectomy Near-total Thyroidectomy

Interventions

Period 1 GX-30, Period 2 THYROGEN®DRUG

Part B - Sequence A. GX-30 0.9mg will be administered at Day 1 and Day 2 in Period 1. After wash-out period of 2 to 3 weeks, THYROGEN® 0.9mg will be administered in Period 2.

Period 1 THYROGEN®, Period 2 GX-30DRUG

Part B - Sequence B. THYROGEN® 0.9mg will be administered at Day 1 and Day 2 in Period 1. After wash-out period of 2 to 3 weeks, GX-30 0.9mg will be administered in Period 2.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who voluntarily consented, after listing enough explanation for this study and investigational product. * Minimum 19 years old. * Minimum 50kg of body weight. * Patients who had undergone total thyroidectomy or near total thyroidectomy due to differentiated thyroid carcinoma. * Patient undergoing thyroid hormone administration. Exclusion Criteria: * Thyroid cancer excluding differentiated thyroid carcinoma. * Thyroidectomy excluding total thyroidectomy and near total thyroidectomy. * Patients with heart, renal, or liver failure. * Patients with ischemic stroke or the history of ischemic stroke. * Smoker or Ex-smoker with less than 3 months of stopping * Patients with migraine or the history of migraine. * Patients that the researchers do not think fit into the group, including patients failed in compliance assessment

Locations (5)

Pusan National University Hospital

Busan, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul Asan Medical Center

Seoul, South Korea

Seoul St. Mary's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Efficacy (Part B)

I-123 Whole body scan image classification

Time frame: at each Day 4, period 1 and period 2.

Secondary Outcomes

TSH concentration (Part B)

TSH concentration for Pharmacokinetics assessment

Time frame: Baseline, Day 1 to Day 8.

ADA (Part B)

Anti-Drug Antibody detection

Time frame: Baseline, Day 1 and 15 of Period 2

Tg concentration (Part B)

Thyroglobulin concentration for secondary efficacy assessment

Time frame: Baseline, Day 1 to Day 5

T3, free T4 concentration (Part B)

Thyroid hormones concentration for pharmacodynamic assessment

Time frame: Baseline, Day 1, 2, 5 of each period and Day 15 of period 2.

Adverse events (Part B)

Safety assessment

Time frame: through study completion, average of 6 weeks.

Data from ClinicalTrials.gov

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