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

Phase 1

Completed

• Conditions: Total Thyroidectomy; Near-total Thyroidectomy
• Interventions: Drug: Period 1 GX-30, Period 2 THYROGEN®; Drug: Period 1 THYROGEN®, Period 2 GX-30

• Registration Number: NCT03276988
• Lead Sponsor: Genexine, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-06
• Study Start: 2017-09-07
• Study First Posted: 2017-09-08
• Primary Completion: 2020-01-20
• Study Completion: 2020-01-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part B - Sequence A	Period 1 GX-30, Period 2 THYROGEN®	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
Part B - Sequence B	Period 1 THYROGEN®, Period 2 GX-30	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

Primary Outcome Measures

Name	Time	Method
Efficacy (Part B)	at each Day 4, period 1 and period 2.	I-123 Whole body scan image classification

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Seoul Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of