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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Genexine, Inc.
- Enrollment
- 8
- Locations
- 5
- Primary Endpoint
- Efficacy (Part B)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
At Part B, Both independent central efficacy assessors and participants will be masked. Investigators will be unmasked. (The Part A was open-label.)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Period 1 GX-30, Period 2 THYROGEN® (Drug)
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
Intervention: Period 1 THYROGEN®, Period 2 GX-30 (Drug)
Outcomes
Primary Outcomes
Efficacy (Part B)
Time Frame: at each Day 4, period 1 and period 2.
I-123 Whole body scan image classification
Secondary Outcomes
- ADA (Part B)(Baseline, Day 1 and 15 of Period 2)
- Adverse events (Part B)(through study completion, average of 6 weeks.)
- TSH concentration (Part B)(Baseline, Day 1 to Day 8.)
- Tg concentration (Part B)(Baseline, Day 1 to Day 5)
- T3, free T4 concentration (Part B)(Baseline, Day 1, 2, 5 of each period and Day 15 of period 2.)