Clinical trials: sponsored by Shanghai Henlius Biotech
Health Adult Subjects
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
This is a randomized, double-blind, parallel-controlled study to compare the PK profile of HLX29 and HLX11 and evaluate their safety, tolerability, and immunogenicity after a single intravenous dose in healthy male adult…
- Trial name
- NCT07776132
- Testing
- HLX29, HLX11
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Health Adult Subjects
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®
The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent…
- Trial name
- NCT07495930
- Testing
- HLX319, EU-Phesgo
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy Adult Male
A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects
The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
- Trial name
- NCT07484893
- Testing
- recombinant human hyaluronidase
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
IPF
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects
The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and…
- Trial name
- NCT06310746
- Testing
- GARP/TGF-β1 monoclonal antibody
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Cancer, mCRC
Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics
This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects.
- Trial name
- NCT06980454
- Testing
- HLX05, EU-Erbitux®, US-Erbitux®
- Where
- 2 sites in China
- Volunteers
- 322 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy Male Volunteers
Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects
Part I of the study： This is a randomised, single-dose, subcutaneous injection, parallel study designed to compare the PK of HLX14 and EU-sourced Prolia® in healthy Chinese adult male subjects, and to assess the safety…
- Trial name
- NCT04534582
- Testing
- HLX14, EU-Prolia®, US-Prolia®
- Where
- China
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Multiple Myeloma
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects
Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX15 with Daratumumab Injection in Healthy Chinese Male Subjects
- Trial name
- NCT05679258
- Testing
- HLX15, US-sourced DARZALEX®, CN-sourced DARZALEX®
- Where
- 2 sites in China
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
EGFR Overexpression
A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects
This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects.
- Trial name
- NCT06309043
- Testing
- recombinant anti-EGFR human/murine chimeric monoclonal antibody injection
- Where
- China
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
NSCLC
Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects
This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design.
- Trial name
- NCT05902728
- Testing
- HLX208, Itraconazole 200 mg, Rifampicin
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Mass Balance Study in Healthy Subjects
Mass Balance Study of [14C]HLX208 in China Healthy Subjects
Mass Balance Study of [14C]HLX208 in China Healthy Subjects.
- Trial name
- NCT05841940
- Testing
- [14C]HLX208
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy Male Volunteers
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects
Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX13 with YERVOY® Injection in Healthy Chinese Male Subjects
- Trial name
- NCT06159101
- Testing
- HLX13, CN-sourced ipilimumab, EU-sourced ipilimumab group
- Where
- China
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
COVID-19
Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2 in China
- Trial name
- NCT05682599
- Testing
- Azvudine
- Where
- China
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
SARS-CoV-2 Infection
Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2
- Trial name
- NCT05633433
- Testing
- Azvudine
- Where
- 10 sites in Malaysia, Philippines
- Volunteers
- 1,550 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
COVID-19
Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers
A single-center, randomized, double-blind, placebo-controlled, dose escalation, phase I clinical study to evaluate safety and pharmacokinetics of HLX70 in healthy adult volunteers
- Trial name
- NCT05429385
- Testing
- HLX70
- Volunteers
- healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects
Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and German).
- Trial name
- NCT02581748
- Testing
- HLX02, Herceptin
- Where
- China
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).
- Trial name
- NCT04670796
- Testing
- HLX02, EU-sourced Trastuzumab (Herceptin®), US-licensed Trastuzumab (Herceptin®)
- Where
- China
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy Male Subjects
Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX04 Versus Avastin® in Healthy Male Subjects
This is a Phase I, randomized, double blind, IV, single dose, 4-arm parallel study to compare the PK, and to evaluate the safety, tolerability and immunogenicity of HLX04, US Avastin®, EU Avastin®, and CN Avastin® in healthy male…
- Trial name
- NCT03483649
- Testing
- HLX04, US-Avastin®, EU-Avastin®
- Where
- China
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy Male Volunteers
Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects
This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety…
- Trial name
- NCT04411550
- Testing
- HLX11, CN-Perjeta(Pertuzumab), EU-Perjeta(Pertuzumab)
- Where
- China
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Healthy Male Volunteers
Compare Pharmacokinetic, Safety, Tolerability and Immunogenicity of HLX12 and Ramucirumab in Healthy Male Adult Subjects
The study consists of 2 parts: Part I study: to preliminarily compare the PK profile of HLX12 and Cyramza This study is an open-label, randomized, parallel-controlled, intravenous single-dose pretrial study comparing the…
- Trial name
- NCT03863587
- Testing
- HLX12, Cyramza (Ramucirumab)
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Immune System Disorder
Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects
This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spourced,40 mg/0.8 mL injection…
- Trial name
- NCT03357939
- Testing
- HLX03, adalimumab
- Where
- China
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech