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

• Status: Completed
• Trial end date: 2020-01-20
• Target enrollment: 0
• Participant gender: All

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®.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genexine, Inc.
• Collaborator: Symyoo

Criteria

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