Clinical trials: sponsored by Xiamen Amoytop Biotech Co., Ltd.
Idiopathic Short Stature
A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
This study is a multicenter, open-label, single-arm extension study to evaluate the safety and efficacy of long-term administration of Inpegsomatropin Injection in participants with Idiopathic Short Stature (ISS) who have…
- Trial name
- NCT07894341
- Testing
- Inpegsomatropin Injection
- Where
- 27 sites in China
- Volunteers
- 300 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B
This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic…
- Trial name
- NCT07589400
- Testing
- ACT500 Tablets
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Metabolic Dysfunction-associated Steatohepatitis
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)
This study is a multicenter, open-label, dose-escalation trial designed to evaluate the safety, tolerability, PK, and PD profiles of ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD).
- Trial name
- NCT07462455
- Testing
- ACT500 tablets
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Chronic Hepaititis B
ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis B (CHB)
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial consisting of two parts. Part 1 includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts conducted in healthy…
- Trial name
- NCT07741461
- Testing
- ACT201 Injection
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Adult Growth Hormone Deficiency
Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency
This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial. A total of 36 adult participants with growth hormone deficiency will be enrolled sequentially in ascending dose…
- Trial name
- NCT07551804
- Testing
- Inpegsomatropin Injection
- Where
- 6 sites in China
- Volunteers
- 36 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Turner Syndrome
The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature
This is a multicenter, randomized, open-label, positive-controlled phase III confirmatory clinical study. A total of 84 children with short stature due to Turner Syndrome (TS) are planned to be enrolled.
- Trial name
- NCT07614152
- Testing
- Inpegsomatropin-Injection, Givopegsomatropin Solution Injection
- Where
- 51 sites in China
- Volunteers
- 84 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Small for Gestational Age
The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in…
- Trial name
- NCT07309562
- Testing
- Inpegsomatropin Injection, Recombinant Human Growth Hormone Injection
- Where
- 49 sites in China
- Volunteers
- 141 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Preeclampsia
Safety, Tolerability, and PK/PD of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing
This is an open-label, single-arm, Phase Ⅰa clinical study designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of multiple doses of Telpegfilgrastim Injection in non-pregnant…
- Trial name
- NCT06924385
- Testing
- Telpegfilgrastim Injection
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Idiopathic Short Stature
The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in…
- Trial name
- NCT06927310
- Testing
- Inpegsomatropin Injection, Recombinant Human Growth Hormone Injection
- Where
- 38 sites in China
- Volunteers
- 300 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Non-alcoholic Steatohepatitis
Safety, Tolerability, and Pharmacokinetics of ACT500 in Healthy Adult Participants
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, divided into two parts. The first part is a single-dose escalation study (Part1,SAD study phase), and the second part is a…
- Trial name
- NCT06716905
- Testing
- ACT500 tablets
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..
This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of ACT100 in…
- Trial name
- NCT07408908
- Testing
- ACT100 Injection
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Essential Thrombocythemia
Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET
This is a multicenter, randomized, open-label Phase 2 clinical study. It is aimed to enroll 27 essential thrombocytopenia (ET) patients who are resistant to or intolerant of hydroxyurea(HU).
- Trial name
- NCT06552429
- Testing
- Peginterferon α-2b injection
- Where
- 8 sites in China
- Volunteers
- 27 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Preeclampsia
Safety, Tolerability, and PK/PD of Telpegfilgrastim in Premenopausal Non-pregnant Females
This is an open-label, Phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of single dose of telpegfilgrastim injection in healthy premenopausal non-pregnant…
- Trial name
- NCT06893796
- Testing
- Telpegfilgrastim Injection
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Chronic Hepatitis B
A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
Studies have shown that chronic hepatitis B patients with low levels of HBsAg after nucleos(t)ide analog therapy have a higher chance of functional cure with sequential or combined pegylated interferon therapy, with about 30-50%…
- Trial name
- NCT06707922
- Testing
- Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate
- Where
- 30 sites in China
- Volunteers
- 350 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Chronic Hepatitis B
A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied.
- Trial name
- NCT04846491
- Testing
- Peginterferon alfa-2b injection, TDF
- Where
- 33 sites in China
- Volunteers
- 475 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Idiopathic Short Stature, Small for Gestational Age
A Trial of YPEG-rhGH in Children With Short Stature
To explore the dose-response relationship between pharmacokinetics and pharmacodynamics of Y- Shaped Pegylated growth hormone injection (YPEG-GH) in children with short stature (idiopathic short stature (ISS), small for…
- Conditions
- Idiopathic Short Stature, Small for Gestational Age, Turner Syndrome
- Trial name
- NCT05838885
- Testing
- YPEG-rhGH, rhGH
- Where
- 19 sites in China
- Volunteers
- 78 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Growth Hormone Deficiency
Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children
This is a multicenter, randomized, open-labeled, positive controlled phase 2\&3 combined study to evaluate the safety and efficacy of weekly Y-shape pegylated somatropin, compared to daily somatropin (Norditropin®), in…
- Trial name
- NCT04513171
- Testing
- Y-shape pegylated somatropin, Norditropin®, Norditropin
- Where
- China
- Volunteers
- 434 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Renal Anemia of Chronic Kidney Disease
A Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease
The purpose of this study is to evaluate the effectiveness and safety of YPEG rhEPO, a recombinant human erythropoietin pegylated by Y shape polyethylene glycol, in patients with anemia due to Chronic Kidney Disease (CKD)…
- Trial name
- NCT04885647
- Testing
- YPEG-rhEPO
- Where
- 17 sites in China
- Volunteers
- 60 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Non-Myeloid Malignancy
Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy
This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelosuppressive Chemotherapy which…
- Trial name
- NCT04466137
- Testing
- YPEG-rhG-CSF, rhG-CSF/PEG-rhG-CSF
- Where
- China
- Volunteers
- 398 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Hepatitis B
Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy
In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled.
- Trial name
- NCT03181113
- Testing
- Peginterferon Alfa-2B, Peginterferon Alfa-2A
- Where
- 28 sites in China
- Volunteers
- 473 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.