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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2020-01-20

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®.

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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.

Conditions

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Total Thyroidectomy Near-total Thyroidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

At Part B, Both independent central efficacy assessors and participants will be masked. Investigators will be unmasked. (The Part A was open-label.)

Study Groups

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Part B - Sequence A

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

Group Type OTHER

Period 1 GX-30, Period 2 THYROGEN®

Intervention Type 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.

Part B - Sequence B

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

Group Type OTHER

Period 1 THYROGEN®, Period 2 GX-30

Intervention Type DRUG

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.

Interventions

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Period 1 GX-30, Period 2 THYROGEN®

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.

Intervention Type DRUG

Period 1 THYROGEN®, Period 2 GX-30

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.

Intervention Type DRUG

Other Intervention Names

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Thyrotropin alpha Thyrotropin alpha

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No