Immune System DisorderPhase 1NCT03357939
Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects
A Phase 1 study testing HLX03 and adalimumab in people with Immune System Disorder, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
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 with a single-use prefilled syringe). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immune System Disorder
- What is being tested?
- HLX03 and adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2017to 15 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese males (age: 18~45 yrs) with contraception during and 3 months post-dose. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.
- BMI between 19.0 and 28.0 kg/m² and body weight between 55 kg and 80 kg.
Who cannot join
- suffering from active or latent tuberculosis or history of tuberculosis;
- have heart disease or a history of heart disease;
- suffer from mental illness or psychiatric history;
- suffering from malignant tumors and their history;
- suffering from herpes zoster and its history;
- suffering from epilepsy and history of epilepsy;
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- be allergic to the drugs or its components with high sensitivity or allergic reaction, detection of ADA (+);
- patients who lost blood or donated more than 200 mL within the first 2 months before the screening;
- major surgery performed within 30 days prior to signing ICF;
- live vaccine inoculation or vaccination within 12 weeks of screening, or possible administration of vaccine during screening and study visits;
- previous application of adalimumab or its biosimilars, or anti-TNF alpha drugs;
- participating in other clinical trials within the first 3 months of the trial;
- abnormal immune function within 4 weeks before screening;
- the presence of invasive systemic fungal infection or other opportunistic infections within 2 months prior to screening;
- systemic or local infection, such as the risk of sepsis and / or known active inflammation within 2 months before screening;
- 2 months before the screening, there were severe infections in the hospital and / or the need for intravenous antibiotics;
- 4 or more upper respiratory tract infections occurred within 6 months prior to randomization;
- hepatitis B surface antigen (HBsAg) positive; if hepatitis B surface antigen (HBsAg) negative, hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus deoxyribonucleic acid (DNA) test >0 IU/ml also ruled out;
- hepatitis C virus (HCV) antibody positive;
- human immunodeficiency virus (HIV) antibody positive;
- Treponema pallidum (Treponema pallidum, TP) antibody positive;
- anti nuclear antibody titer was 1:100 examination;
- drug abusers, alcohol addicts;
- , the researchers discretion of failure to follow the requirements of the program, instructions and research limitations, such as uncooperative attitude, unable to return to the Research Center for follow-up visits, or unable to complete the entire clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized,Double-Blind and Parallel Controlled Single-dose Clinical Trial of Pharmacokinetics, Safety, Tolerability and Immunogenicity of HLX03 Compared With Humira® From China Source in Chinese Healthy Male 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 with a single-use prefilled syringe). This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity evaluation of drug levels following administration of HLX03 and the licensed adalimumab products.
Read the detailed description
This is a randomized, doubl-blinded, parellel-controlled phase 1 PK, safety, tolerability and immunogenicitiy study to compare HLX03, designed as an Adalimumab biosimilar, with China sourced Humira in Chinese health volunteers. All enrolled subjects will receive a single dose of HLX03 (40 mg）or Humira(adalimumab, 40 mg) in subcutaneous injectioin after randomization.
The purpose of this study to prove the similarity in PK, Safety, tolerability and immunogenicity beween HLX03（adalimumab biosimilar） and China sourced Humira and provide evidence for Phase III comparison study.
The blood will be collected before drug administration, and at 1 hr、4 hr、8 hr、24 hr (1d)、48 hr (2d)、72 hr (3d)、96 hr (4d)、、144 hr (6d)、192 hr (8d)、240 hr (10d)、 336 hr (14d)、504 hr (21d)、672 hr (28d)、840 hr (35d)、1008 hr (42d)、1176 hr (49d)、1344 hr (56d)、1680 hr (70d) after drug injection for PK, ADA, etc analysis. All subjects also will be followed up at 0, 1,2,3,4,6,8,10,14,21,28,35, 42, 49, 56, and 70 days after drug administration for AE and other specified outcomes.
The main endpoint is AUC from time zero to ∞. The second endpoints include Cmax, Tmax, T1/2, CL, Vd and AUC（0-last）.
This is single center study in China.
- Conditions
- Immune System Disorder
- Being tested
- HLX03, adalimumab
- Keywords
- HLX03, adalimumab, pharmacokinetics, biosimilar
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX03Drug
Also called adalimumab biosimilar
A single dose of 40 mg HLX03 in 0.8 mL in subcutaneous injection.
adalimumabDrug
Also called Humira
A single dose of 40 mg Humira in 0.8 mL in a pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| HLX03 | Experimental | There are about 68 subjects in this group will receive a single dose of 40 mg of HLX03 in 0.8 mL in subcutaneous injection. Receives: Drug: HLX03 |
| Humira | Active comparator | There are about 68 subjects in this group will receive a single dose of 40 mg of Humira in a pre-filled syringe in subcutaneous injection. Receives: Drug: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration（Cmax） of Adalimumab After Single SC Injection of HLX03/Humira
Measured: 71 days post-dose
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to the last quantifiable concentration
Measured: 71 days post-dose
Secondary outcomes (3)
Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity
Measured: 71 days post-dose
Time to Maximum Concentration（Tmax） of Adalimumab After Single SC Injection
Measured: 71 days post-dose
Half-life time of adalimumab after single SC injection of HXL03/Humira
Measured: 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start12 Jan 2017
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune System DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, MD, Principal investigator, The 1st affiliated hospital, Jilin University, PRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357939
- Sponsor's protocol ID
- HLX03-HV01
- Status last verified
- May 2022
- First submitted
- 26 Nov 2017
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang H, Wu M, Sun J, Zhu X, Li C, Ding Y, Zhang X, Chai K, Li X. Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double-blind, parallel-controlled, phase 1 study. Pharmacol Res Perspect. 2021 Apr;9(2):e00733. doi: 10.1002/prp2.733.
PubMed 33682358
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized,Double-Blind and Parallel Controlled Single-dose Clinical Trial of Pharmacokinetics, Safety, Tolerability and Immunogenicity of HLX03 Compared With Humira® From China Source in Chinese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03357939
- Acronym / sponsor ID
- HLX03-HV01
- Conditions
- Immune System Disorder
- Keywords
- HLX03, adalimumab, pharmacokinetics, biosimilar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 with a single-use prefilled syringe). This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity evaluation of drug levels following administration of HLX03 and the licensed adalimumab products.
Detailed description
This is a randomized, doubl-blinded, parellel-controlled phase 1 PK, safety, tolerability and immunogenicitiy study to compare HLX03, designed as an Adalimumab biosimilar, with China sourced Humira in Chinese health volunteers. All enrolled subjects will receive a single dose of HLX03 (40 mg）or Humira(adalimumab, 40 mg) in subcutaneous injectioin after randomization.
The purpose of this study to prove the similarity in PK, Safety, tolerability and immunogenicity beween HLX03（adalimumab biosimilar） and China sourced Humira and provide evidence for Phase III comparison study.
The blood will be collected before drug administration, and at 1 hr、4 hr、8 hr、24 hr (1d)、48 hr (2d)、72 hr (3d)、96 hr (4d)、、144 hr (6d)、192 hr (8d)、240 hr (10d)、 336 hr (14d)、504 hr (21d)、672 hr (28d)、840 hr (35d)、1008 hr (42d)、1176 hr (49d)、1344 hr (56d)、1680 hr (70d) after drug injection for PK, ADA, etc analysis. All subjects also will be followed up at 0, 1,2,3,4,6,8,10,14,21,28,35, 42, 49, 56, and 70 days after drug administration for AE and other specified outcomes.
The main endpoint is AUC from time zero to ∞. The second endpoints include Cmax, Tmax, T1/2, CL, Vd and AUC（0-last）.
This is single center study in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX03 | Experimental | Drug: HLX03There are about 68 subjects in this group will receive a single dose of 40 mg of HLX03 in 0.8 mL in subcutaneous injection. |
| Humira | Active comparator | Drug: adalimumabThere are about 68 subjects in this group will receive a single dose of 40 mg of Humira in a pre-filled syringe in subcutaneous injection. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Chinese males (age: 18~45 yrs) with contraception during and 3 months post-dose. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.
- BMI between 19.0 and 28.0 kg/m² and body weight between 55 kg and 80 kg.
Key exclusion criteria (24 listed)
- suffering from active or latent tuberculosis or history of tuberculosis;
- have heart disease or a history of heart disease;
- suffer from mental illness or psychiatric history;
- suffering from malignant tumors and their history;
- suffering from herpes zoster and its history;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX03Also: adalimumab biosimilarA single dose of 40 mg HLX03 in 0.8 mL in subcutaneous injection. | Drug | HLX03 |
| adalimumabAlso: HumiraA single dose of 40 mg Humira in 0.8 mL in a pre-filled syringe | Drug | Humira |
Primary outcome
Maximum Concentration（Cmax） of Adalimumab After Single SC Injection of HLX03/Humira
Time frame: 71 days post-dose
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to the last quantifiable concentration
Time frame: 71 days post-dose
3 secondary outcomes
Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity
Time frame: 71 days post-dose
Time to Maximum Concentration（Tmax） of Adalimumab After Single SC Injection
Time frame: 71 days post-dose
Half-life time of adalimumab after single SC injection of HXL03/Humira
Time frame: 71 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Results publication: PubMed 33682358Zhang H, Wu M, Sun J, Zhu X, Li C, Ding Y, Zhang X, Chai K, Li X. Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double-blind, parallel-controlled, phase 1 study. Pharmacol Res Perspect. 2021 Apr;9(2):e00733. doi: 10.1002/prp2.733.
- FRI0086 CHINA-MANUFACTURED ADALIMUMAB BIOSIMILAR, HLX03, DEMONSTRATED PHARMACOKINETIC EQUIVALENCE AND COMPARABLE SAFETY TO REFERENCE ADALIMUMAB，EULAR 2019 (Poster); Annals of the Rheumatic DiseasesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanhua Ding, MD principal investigator
The 1st affiliated hospital, Jilin University, PRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX03 and adalimumab in people with Immune System Disorder, run by Shanghai Henlius Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Concentration（Cmax） of Adalimumab After Single SC Injection of HLX03/Humira (time frame: 71 days post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03357939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.