Clinical trials: sponsored by GC Biopharma Corp
Influenza A, Influenza B, Influenza Vaccination
Phase 2/3 Clinical Trial to Evaluate the Immunogenicity and Safety of GC3114B in Adults Aged 65 Years or Older
This is a multicenter, randomized, double-blind, active-controlled, parallel-group clinical trial in adults aged 65 years or older.
- Trial name
- GC3114B (NCT07883928)
- Testing
- vaccination of GC3114B, Vaccination of Efluelda
- Where
- South Korea
- Volunteers
- 1,806 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
Sanfilippo Syndrome Type A
Phase 1 Study of GC1130A in Patients With Sanfilippo Syndrome Type A (MPS IIIA)
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of recombinant human heparan N-sulfatase (rhHNS, GC1130A) administered via intracerebroventricular access device…
- Trial name
- NCT06567769
- Testing
- GC1130A
- Where
- 4 sites in United States, South Korea
- Volunteers
- 9 people
- Sponsor
- GC Biopharma Corp
COVID - 19
A Phase 1 Study to Evaluate the Safety and Immunogenicity of GC4006A in Healthy Adults
A Phase 1, Randomized, Double-blind, Dose-Escalation, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of the COVID-19 Preventive Vaccine 'GC4006A' in Healthy Adults Aged 19 to 64 Years
- Trial name
- NCT07728396
- Testing
- GC4006A, Normal Saline
- Where
- South Korea
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
Varicella (Chickenpox), Chickenpox Vaccine
A Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years
This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up…
- Trial name
- NCT07054099
- Testing
- MG1111 (Barycela inj.), VARIVAX™
- Where
- Thailand
- Volunteers
- 474 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
MPS II, Hunter Syndrome (MPS II)
An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta)
The objective of this study is to assess the long-term safety and efficacy of Hunterase for approximately 1 year in subjects who completed the end of study (EOS) visit (Visit 54) tests in the Phase 3 Hunterase study and patients…
- Conditions
- MPS II, Hunter Syndrome (MPS II), Hunter Syndrome, Hunterase
- Trial name
- NCT07344376
- Testing
- Hunterase
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- GC Biopharma Corp
Hemophilia
A Phase 1b Study to Assess the Safety, Tolerability, PK and PD of MG1113 in Hemophilia Patient
The purpose of this study is to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of subcutaneous MG1113 in the multiple ascending dose study in patients with severe hemophilia.
- Trial name
- NCT05493631
- Testing
- MG1113
- Where
- South Korea
- Volunteers
- 15 people
- Sponsor
- GC Biopharma Corp
Fabry Disesase
A proof-of Concept Study to Assess Safety and Tolerability of HM15421/GC1134A in Patients With Fabry Disease
This Phase 1/2 first-in-human (FIH) study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15421 in patients with FD.
- Trial name
- NCT06858397
- Testing
- HM15421/GC1134A
- Where
- 10 sites in United States, Argentina and 1 more
- Volunteers
- 18 people
- Sponsor
- GC Biopharma Corp
Primary Immune Deficiency
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).
- Trial name
- NCT04565015
- Testing
- GC5107
- Where
- 8 sites in United States, Bosnia and Herzegovina and 1 more
- Volunteers
- 24 people
- Sponsor
- GC Biopharma Corp
Hypertension, Dyslipidemia
Evaluation of the Effectiveness and Safety of Rozetel Tablet in Patients After PCI: A Multi-Center Observational Study
The purpose of this study is to evaluate the effectiveness and safety of the investigational drug on blood pressure and LDL cholesterol control during the observation period in patients who have undergone percutaneous coronary…
- Trial name
- NCT07084246
- Where
- South Korea
- Volunteers
- 1,563 people
- Sponsor
- GC Biopharma Corp
Tetanus-diphtheria-acellular Pertussis (Tdap)
A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity).
- Trial name
- NCT06997627
- Testing
- GC3111B, Boostrix®
- Where
- South Korea
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
Hepatitis B
A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients
- Trial name
- NCT05686759
- Testing
- Undiluted I.V.-Hepabig inj(GC5103), Diluted I.V.-Hepabig inj(GC5103)
- Where
- 8 sites in South Korea
- Volunteers
- 105 people
- Sponsor
- GC Biopharma Corp
Mucopolysaccharidosis II, Hunter Syndrome
A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intracerebroventricular GC1123 in patients with MPS Ⅱ who have central nervous system involvement and are receiving…
- Trial name
- NCT05422482
- Testing
- GC1123
- Where
- 3 sites in South Korea
- Volunteers
- 12 people
- Sponsor
- GC Biopharma Corp
Healthy Volunteers
A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions
The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fed conditions to healthy adult volunteers.
- Trial name
- NCT05729386
- Testing
- GC2129A(Period 1), Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1), GC2129A(Period 2)
- Where
- South Korea
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
Healthy Volunteers
A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fasting Conditions
The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers.
- Trial name
- NCT05703984
- Testing
- GC2129A(Period 1), Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1), GC2129A(Period 2)
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
Varicella Zoster Virus Infection
An Open-label, Bridging Study of BARYCELA Inj. in Healthy Vietnamese Children Aged Between 12 Months to 12 Years
The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are: Safety of BARYCELA inj.
- Trial name
- NCT05664152
- Testing
- MG1111
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp