Healthy Male VolunteersPhase 1NCT06159101
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects
A Phase 1 study testing HLX13, CN-sourced ipilimumab and EU-sourced ipilimumab group in people with Healthy Male Volunteers, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- HLX13, CN-sourced ipilimumab and EU-sourced ipilimumab group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2023to 28 May 2024
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to sign the informed consent form.
- Healthy Chinese males (no significant clinical abnormalities in medical history, physical examination, vital signs, chest X-ray, 12-lead ECG, and laboratory examinations).
- Age ≥ 18 and ≤ 60 years old.
- Body mass index (BMI) ≥ 18.5 and ≤ 28 kg/m2.
- Left ventricular ejection fraction (LVEF) > 50%, as measured by echocardiography within 14 days before randomization.
- Subjects either agree that they and their spouse/partner will take reliable contraceptive measures within 3 months after the end of drug infusion or be infertile.
Who cannot join
- History of any severe hematological or renal, endocrinic, respiratory, gastrointestinal, cardiovascular, hepatic, neuropsychiatric, or neurological diseases or tumors.
- Use of a monoclonal antibody or any biological product within 6 months prior to the study treatment.
- History of allergy or anaphylaxis, including that due to any drug or drug excipients in clinical studies.
- Use of prescription/over-the-counter drugs or traditional Chinese medicines (except vitamins, mineral supplements, and health products) within 28 days prior to the study treatment.
- History of blood donation within 3 months prior to the study treatment.
- Participation in another clinical study and use of a clinical investigational drug or reference product within 3 months prior to the study treatment, or planning to participate in another drug clinical trial during the study period.
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- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
- History of drug abuse, or positive urine drug screen during the screening period.
- Have undergone surgery within 3 months before screening or plan to undergo surgery during the study period; have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion.
- Have been vaccinated within 28 days prior to screening or plan to be vaccinated during the study.
- Intolerant to venipuncture or with a history of needle or blood phobia.
- People on special diets who reject the arranged meals.
- Smoking more than 5 cigarettes per day within 3 months before screening or cannot stop using any tobacco products during the study.
- An average daily alcohol intake of more than 15 g (equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol liquor) within 1 month prior to screening; or a positive blood alcohol test at screening; or unwilling or unable to abstain from alcohol during the study.
- Failure to comply with protocol requirements and instructions, protocol restrictions, etc., as judged by the investigator; uncooperative or unable to return to the study site for follow-up visits or complete the entire clinical study process, etc.
Trial locations and contacts
1 site in 1 country.
Hu Wei contact
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Anhui Medical University
Anhui, Anhui
Hu Wei, +86-0551-65997165
About this study
Official title: A Randomized, Intravenous Single-Dose, Parallel, Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX13 and YERVOY® (US-, EU-, and CN-Sourced) in Healthy Chinese 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
Read the detailed description
This is a randomized, intravenous single-dose, parallel study to compare the PK characteristics of HLX13 and YERVOY® (US-, EU-, and CN-sourced) and evaluate their safety, tolerability, and immunogenicity in healthy Chinese male subjects.
This study is divided into two parts. Part I is an open-label, randomized, single-dose, parallel study to compare the PK parameters of HLX13 with those of EU-sourced YERVOY® in healthy Chinese male subjects after a single intravenous infusion and provide supporting data for the design of Part II. This part of the study consists of two groups.
Part II is a double-blind, randomized, single-dose, parallel study to evaluate the PK similarity of HLX 13 and YERVOY® (US-, EU-, and CN-sourced) in healthy Chinese male subjects. This part of the study consists of four groups.
- Conditions
- Healthy Male Volunteers
- Being tested
- HLX13, CN-sourced ipilimumab, EU-sourced ipilimumab group, US-sourced ipilimumab group
- Keywords
- CTLA-4
- Medical subject headings
- Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX13Drug
A single dose (0.3 mg/kg) of HLX13 via intravenous infusion.
CN-sourced ipilimumabDrug
A single dose (0.3 mg/kg) of CN-sourced ipilimumab via intravenous infusion.
EU-sourced ipilimumab groupDrug
A single dose (0.3 mg/kg) of EU-sourced ipilimumab via intravenous infusion.
US-sourced ipilimumab groupDrug
A single dose (0.3 mg/kg) of US-sourced ipilimumab via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| HLX13 group | Experimental | Recombinant anti-CTLA-4 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc. Receives: Drug: HLX13 |
| CN-sourced ipilimumab group | Active comparator | CN-sourced ipilimumab Receives: Drug: CN-sourced ipilimumab |
| EU-sourced ipilimumab group | Active comparator | EU-sourced ipilimumab Receives: Drug: EU-sourced ipilimumab group |
| US-sourced ipilimumab group | Active comparator | US-sourced ipilimumab Receives: Drug: US-sourced ipilimumab group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 90
Maximum (peak) serum drug concentration (Cmax)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 90
Secondary outcomes (7)
Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 90
Percentage of area under the serum concentration-time curve extrapolated to infinity (%AUCex)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 90
Time to reach maximum (peak) serum drug concentration (Tmax)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 90
Elimination half life (t1/2)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 90
Total clearance (CL)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 90
Apparent volume of distribution during terminal phase (Vz)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 90
Mean residence time (MRT)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start28 Nov 2023
- Primary completion28 May 2024 (estimated)
- Study completion28 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hu Wei, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159101
- Sponsor's protocol ID
- HLX13-001
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Intravenous Single-Dose, Parallel, Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX13 and YERVOY® (US-, EU-, and CN-Sourced) in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT06159101
- Acronym / sponsor ID
- HLX13-001
- Conditions
- Healthy Male Volunteers
- Keywords
- CTLA-4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 28 May 2024 (estimated)
- Study completion
- 28 May 2024 (estimated)
- First posted
- 6 Dec 2023 (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.
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
Detailed description
This is a randomized, intravenous single-dose, parallel study to compare the PK characteristics of HLX13 and YERVOY® (US-, EU-, and CN-sourced) and evaluate their safety, tolerability, and immunogenicity in healthy Chinese male subjects.
This study is divided into two parts. Part I is an open-label, randomized, single-dose, parallel study to compare the PK parameters of HLX13 with those of EU-sourced YERVOY® in healthy Chinese male subjects after a single intravenous infusion and provide supporting data for the design of Part II. This part of the study consists of two groups.
Part II is a double-blind, randomized, single-dose, parallel study to evaluate the PK similarity of HLX 13 and YERVOY® (US-, EU-, and CN-sourced) in healthy Chinese male subjects. This part of the study consists of four groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HLX13 group | Experimental | Drug: HLX13Recombinant anti-CTLA-4 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc. |
| CN-sourced ipilimumab group | Active comparator | Drug: CN-sourced ipilimumabCN-sourced ipilimumab |
| EU-sourced ipilimumab group | Active comparator | Drug: EU-sourced ipilimumab groupEU-sourced ipilimumab |
| US-sourced ipilimumab group | Active comparator | Drug: US-sourced ipilimumab groupUS-sourced ipilimumab |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing to sign the informed consent form.
- Healthy Chinese males (no significant clinical abnormalities in medical history, physical examination, vital signs, chest X-ray, 12-lead ECG, and laboratory examinations).
- Age ≥ 18 and ≤ 60 years old.
- Body mass index (BMI) ≥ 18.5 and ≤ 28 kg/m2.
- Left ventricular ejection fraction (LVEF) > 50%, as measured by echocardiography within 14 days before randomization.
Key exclusion criteria (15 listed)
- History of any severe hematological or renal, endocrinic, respiratory, gastrointestinal, cardiovascular, hepatic, neuropsychiatric, or neurological diseases or tumors.
- Use of a monoclonal antibody or any biological product within 6 months prior to the study treatment.
- History of allergy or anaphylaxis, including that due to any drug or drug excipients in clinical studies.
- Use of prescription/over-the-counter drugs or traditional Chinese medicines (except vitamins, mineral supplements, and health products) within 28 days prior to the study treatment.
- History of blood donation within 3 months prior to the study treatment.
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 |
|---|---|---|
| HLX13A single dose (0.3 mg/kg) of HLX13 via intravenous infusion. | Drug | HLX13 group |
| CN-sourced ipilimumabA single dose (0.3 mg/kg) of CN-sourced ipilimumab via intravenous infusion. | Drug | CN-sourced ipilimumab group |
| EU-sourced ipilimumab groupA single dose (0.3 mg/kg) of EU-sourced ipilimumab via intravenous infusion. | Drug | EU-sourced ipilimumab group |
| US-sourced ipilimumab groupA single dose (0.3 mg/kg) of US-sourced ipilimumab via intravenous infusion. | Drug | US-sourced ipilimumab group |
Primary outcome
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Maximum (peak) serum drug concentration (Cmax)
Time frame: Up to Day 90
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
7 secondary outcomes
Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
Time frame: Up to Day 90
Percentage of area under the serum concentration-time curve extrapolated to infinity (%AUCex)
Time frame: Up to Day 90
Time to reach maximum (peak) serum drug concentration (Tmax)
Time frame: Up to Day 90
Elimination half life (t1/2)
Time frame: Up to Day 90
Total clearance (CL)
Time frame: Up to Day 90
Apparent volume of distribution during terminal phase (Vz)
Time frame: Up to Day 90
Mean residence time (MRT)
Time frame: Up to Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Hu Wei contact
Hu Wei principal investigator
The Second Hospital of Anhui Medical University
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 HLX13, CN-sourced ipilimumab and EU-sourced ipilimumab group in people with Healthy Male Volunteers, 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu Wei (+86-0551-65997165), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) (time frame: Up to Day 90). 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?
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 6 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.