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

Study Overview
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Brief Summary
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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®.

Detailed Description
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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.

Official Title
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A Prospective, Open-label, Dose Escalation,(Phase 1); Prospective, Randomized, Evaluator Blinded, Active-controlled, 2-sequence, 2-period, 2-treatment, Crossover(Phase 2); Phase 1/2 Clinical Trial to Evaluate the Tolerability, Pharmacokinetics, Safety and Efficacy of GX-30 Administered Intramuscularly in Patients Underwent Total Thyroidectomy or Near Total Thyroidectomy

Conditions
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Total Thyroidectomy, Near-total Thyroidectomy

Intervention / Treatment
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* Drug: Period 1 GX-30, Period 2 THYROGEN®
* Drug: Period 1 THYROGEN®, Period 2 GX-30


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The Part A (Phase 1) of study has been completed in which 3 single or multiple sequentially assenting doses of GX-30 were investigated. The Part B (Phase 2) is recruiting in current in which each study participant will receive the same multiple doses of GX-30 and THYROGEN® but at different period.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Part B - Sequence A<br>Period 1 GX-30 0.9mg x 2 (Day 1 and Day 2), IM injection. Period 2 THYROGEN® 0.9mg x 2 (Day 1 and Day 2), IM injection | Drug: Period 1 GX-30, Period 2 THYROGEN®<br>* 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.<br>* Other names: Thyrotropin alpha;|
| Other: Part B - Sequence B<br>Period 1 THYROGEN® 0.9mg x 2 (Day 1 and Day 2), IM injection. Period 2 GX-30 0.9mg x 2 (Day 1 and Day 2), IM injection | Drug: Period 1 THYROGEN®, Period 2 GX-30<br>* 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.<br>* Other names: Thyrotropin alpha;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (Part B) | I-123 Whole body scan image classification | at each Day 4, period 1 and period 2. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSH concentration (Part B) | TSH concentration for Pharmacokinetics assessment | Baseline, Day 1 to Day 8. | 
| ADA (Part B) | Anti-Drug Antibody detection | Baseline, Day 1 and 15 of Period 2 | 
| Tg concentration (Part B) | Thyroglobulin concentration for secondary efficacy assessment | Baseline, Day 1 to Day 5 | 
| T3, free T4 concentration (Part B) | Thyroid hormones concentration for pharmacodynamic assessment | Baseline, Day 1, 2, 5 of each period and Day 15 of period 2. | 
| Adverse events (Part B) | Safety assessment | through study completion, average of 6 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid cancer, Thyroidectomy, rhTSH, GX-30