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

Genexine

Status and phase: Completed; Phase 2; Phase 1

Conditions: Near-total Thyroidectomy; Total Thyroidectomy

Treatments: Drug: Period 1 GX-30, Period 2 THYROGEN®; Drug: Period 1 THYROGEN®, Period 2 GX-30

Study type: Interventional

Funder types: Industry

Identifiers

NCT03276988

GX30_P1/2

Details and patient eligibility

About

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®.

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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8 participants in 2 patient groups

Part B - Sequence A

Other group

Description:

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

Treatment:

Drug: Period 1 GX-30, Period 2 THYROGEN®

Part B - Sequence B

Other group

Description:

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

Treatment:

Drug: Period 1 THYROGEN®, Period 2 GX-30