Multiple MyelomaPhase 1NCT05679258
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects
A Phase 1 study testing HLX15, US-sourced DARZALEX® and CN-sourced DARZALEX® in people with Multiple Myeloma, run by Shanghai Henlius Biotech at 2 sites in China.
Trial summary
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 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
- Multiple Myeloma
- What is being tested?
- HLX15, US-sourced DARZALEX® and CN-sourced DARZALEX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 2 sitesChina
- Study dates
- 31 Jan 2023to 28 Jun 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
- Age ≥ 18 years and ≤ 60 years at the time of signing the informed consent form (ICF);
- Sex: male;
- Body weight and body mass index (BMI): 18.5 kg/m2 ≤ BMI < 28 kg/m2; body weight ≥ 55 kg;
- The subject should be judged by the physician to be in good general health according to the results of medical history, physical examination, vital signs, ECG examination, laboratory tests, etc. (normal or abnormal without clinical significance);
- The subject should be a voluntary participant who has understood and signed the ICF.
Who cannot join
- Subjects who may have diseases that affect their safety or affect the study results, including but not limited to cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal tract, skin, infection, malignant tumor, hematologic, skeletal, genitourinary, nervous system/ psychiatric or functional disorders, which are judged as clinically significant by the investigator;
- With acute, chronic, or latent infectious diseases within 1 month before administration;
- With known immune system diseases (autoimmune diseases and immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia;
- Has experienced a recent single dermatomal herpes zoster eruption within 6 months before administration;
- Has a history of multi-dermatomal herpes zoster or central nervous system (CNS) herpes zoster during the screening period or before;
- Positive for indirect antiglobulin test (Indirect Coombs test);
Show all 19Show fewer
- Use of monoclonal antibody, cell therapy, etc. within 6 months before administration, or daratumumab or its analogues or drugs targeting CD38 before administration;
- Use of any medication, including prescription drugs, over-the-counter (OTC) drugs, and Chinese herbal medicines, within 2 weeks before administration;
- History of drug or food allergy, including allergy to any drug or drug excipient used in the study;
- Fear of needles or blood, or difficulty in venous blood collection (history of difficult blood collection or corresponding symptoms and signs, unable to tolerate venipuncture);
- History of blood donation or total blood loss of 200 mL or more within 3 months before administration;
- Participants in clinical trials of any other drug or device within 3 months (or 5 half-lives of the corresponding investigational product if the half-life of the drug is long (5 half-lives > 3 months)) before administration;
- Major surgery within 3 months before signing the ICF;
- Positive for hepatitis B virus (HBsAg or HBcAb-positive) antibodies, hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV), or treponema pallidum antibodies (Anti-TP);
- History of drug abuse or substance abuse, or positive in urine drug screening;
- Patients who have been vaccinated with attenuated or live virus vaccine (such as Bacille Calmette-Guérin, BCG) or viral vector vaccine within 12 months before the first dose, or who plan to be vaccinated with such vaccines within 12 months after administration;
- Patients who have been vaccinated with vaccines other than the above attenuated or live viral vaccines and viral vector vaccines within 1 month before the first dose, such as inactivated vaccines and recombinant subunit vaccines;
- Male subjects with partners of childbearing potential who have a plan to father a child and/or donate sperm from signing of ICF through 3 months after administration, do not agree to abstain completely from sexual intercourse, or plan to use a contraceptive method that is not acceptable to the investigator (unacceptable methods of contraception include: i. periodic abstinence <such as calendar method, ovulation method, basal body temperature method, post-ovulation safety period method, etc.>, withdrawal, etc.; ii. medical contraceptive measures such as oral contraceptives, contraceptive injections, contraceptive patches, subcutaneous implantation, intrauterine hormone contraceptive devices, local contraceptives such as spermicides, etc.);
- Subjects with any other conditions that, in the judgment of the investigator, are ineligible for participation in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Hospital
Beijing, Beijing Municipality, 100730
Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu, 211112
About this study
Official title: A 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
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
Read the detailed description
This study contains two parts. Part I of the study is a single-center, randomized, open-label, 2-arm, parallel-controlled phase Ia study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX15 and daratumumab infusion (DARZALEX®, CN-sourced) in healthy Chinese male subjects.
A total of 24 healthy Chinese male subjects will be enrolled in this part and randomized to the HLX15 group or the CN-sourced DARZALEX® group in a 1:1 ratio, with 12 subjects in each group. The subjects will receive a single dose (8 mg/kg) of HLX15 or CN-sourced DARZALEX® via intravenous infusion.
There is a safety run-in period in the early stage of the study to investigate the safety and tolerability of HLX15 in healthy Chinese male subjects. Another 3-6 subjects will be enrolled to receive the investigational product HLX15 and safety observation will be conducted for 1 week. The Safety Review Committee (SRC) will decide whether to adjust the subsequent study plan based on the safety and tolerability data after administration.
Part II of the study is a multicenter, randomized, double-blind, 3-arm, parallel-controlled phase Ib study to compare similarity of the PK characteristics, safety, tolerability, and immunogenicity of HLX15 and daratumumab infusion (DARZALEX®, US-sourced; DARZALEX®, CN-sourced) in healthy Chinese male subjects.A total of 204 healthy Chinese male subjects are planned to be enrolled in this part and randomly assigned in a 1:1:1 ratio to the HLX15 group, the US-sourced DARZALEX® group, or the CN-sourced DARZALEX® group, with 68 subjects in each group. The subjects will receive a single dose (8 mg/kg) of HLX15, US-sourced DARZALEX®, or CN-sourced DARZALEX® via intravenous infusion.This part may be adjusted according to the results of Part I, including sample size and sampling time points
- Conditions
- Multiple Myeloma
- Being tested
- HLX15, US-sourced DARZALEX®, CN-sourced DARZALEX®, EU-sourced DARZALEX®
- Keywords
- pharmacokinetics, CD38, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX15Drug
Also called Recombinant anti-CD38 fully humanized monoclonal antibody injection
A single dose (8 mg/kg) of HLX15 via intravenous infusion.
US-sourced DARZALEX®Drug
Also called Daratumumab Injection
A single dose (8 mg/kg) of US-sourced DARZALEX® via intravenous infusion.
CN-sourced DARZALEX®Drug
Also called Daratumumab Injection
A single dose (8 mg/kg) of CN-sourced DARZALEX® via intravenous infusion.
EU-sourced DARZALEX®Drug
Also called Daratumumab Injection
A single dose (8 mg/kg) of EU-sourced DARZALEX® via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| HLX15 group | Experimental | Recombinant anti-CD38 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc. Receives: Drug: HLX15 |
| US-sourced DARZALEX® group | Active comparator | Daratumumab injection Receives: Drug: US-sourced DARZALEX® |
| CN-sourced DARZALEX® group | Active comparator | Daratumumab injection Receives: Drug: CN-sourced DARZALEX® |
| EU-sourced DARZALEX® group | Active comparator | Daratumumab injection Receives: Drug: EU-sourced DARZALEX® |
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 91
Secondary outcomes (7)
Area under the serum concentration-time curve from time 0 to the last measurable concentration (AUC0-t);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 91
Maximum (peak) serum drug concentration (Cmax);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 91
Time to reach maximum (peak) serum drug concentration (Tmax);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 91
Volume of distribution during the terminal phase (Vz);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 91
Elimination half-life (t1/2);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 91
Total clearance (CL);
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 91
Percentage of area under serum concentration-time curve obtained by extrapolation (%AUCex).
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Up to Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start31 Jan 2023
- Primary completion16 Mar 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679258
- Sponsor's protocol ID
- HLX15-001
- Status last verified
- Jun 2024
- First submitted
- 21 Dec 2022
- Last updated
- 28 Jun 2024
- 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 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT05679258
- Acronym / sponsor ID
- HLX15-001
- Conditions
- Multiple Myeloma
- Keywords
- pharmacokinetics, CD38, multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 10 Jan 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 HLX15 with Daratumumab Injection in Healthy Chinese Male Subjects
Detailed description
This study contains two parts. Part I of the study is a single-center, randomized, open-label, 2-arm, parallel-controlled phase Ia study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX15 and daratumumab infusion (DARZALEX®, CN-sourced) in healthy Chinese male subjects.
A total of 24 healthy Chinese male subjects will be enrolled in this part and randomized to the HLX15 group or the CN-sourced DARZALEX® group in a 1:1 ratio, with 12 subjects in each group. The subjects will receive a single dose (8 mg/kg) of HLX15 or CN-sourced DARZALEX® via intravenous infusion.
There is a safety run-in period in the early stage of the study to investigate the safety and tolerability of HLX15 in healthy Chinese male subjects. Another 3-6 subjects will be enrolled to receive the investigational product HLX15 and safety observation will be conducted for 1 week. The Safety Review Committee (SRC) will decide whether to adjust the subsequent study plan based on the safety and tolerability data after administration.
Part II of the study is a multicenter, randomized, double-blind, 3-arm, parallel-controlled phase Ib study to compare similarity of the PK characteristics, safety, tolerability, and immunogenicity of HLX15 and daratumumab infusion (DARZALEX®, US-sourced; DARZALEX®, CN-sourced) in healthy Chinese male subjects.A total of 204 healthy Chinese male subjects are planned to be enrolled in this part and randomly assigned in a 1:1:1 ratio to the HLX15 group, the US-sourced DARZALEX® group, or the CN-sourced DARZALEX® group, with 68 subjects in each group. The subjects will receive a single dose (8 mg/kg) of HLX15, US-sourced DARZALEX®, or CN-sourced DARZALEX® via intravenous infusion.This part may be adjusted according to the results of Part I, including sample size and sampling time points
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 |
|---|---|---|
| HLX15 group | Experimental | Drug: HLX15Recombinant anti-CD38 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc. |
| US-sourced DARZALEX® group | Active comparator | Drug: US-sourced DARZALEX®Daratumumab injection |
| CN-sourced DARZALEX® group | Active comparator | Drug: CN-sourced DARZALEX®Daratumumab injection |
| EU-sourced DARZALEX® group | Active comparator | Drug: EU-sourced DARZALEX®Daratumumab injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years and ≤ 60 years at the time of signing the informed consent form (ICF);
- Sex: male;
- Body weight and body mass index (BMI): 18.5 kg/m2 ≤ BMI < 28 kg/m2; body weight ≥ 55 kg;
- The subject should be judged by the physician to be in good general health according to the results of medical history, physical examination, vital signs, ECG examination, laboratory tests, etc. (normal or abnormal without clinical significance);
- The subject should be a voluntary participant who has understood and signed the ICF.
Key exclusion criteria (19 listed)
- Subjects who may have diseases that affect their safety or affect the study results, including but not limited to cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal tract, skin, infection, malignant tumor, hematologic, skeletal, genitourinary, nervous system/ psychiatric or functional disorders, which are judged as clinically significant by the investigator;
- With acute, chronic, or latent infectious diseases within 1 month before administration;
- With known immune system diseases (autoimmune diseases and immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia;
- Has experienced a recent single dermatomal herpes zoster eruption within 6 months before administration;
- Has a history of multi-dermatomal herpes zoster or central nervous system (CNS) herpes zoster during the screening period or before;
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 |
|---|---|---|
| HLX15Also: Recombinant anti-CD38 fully humanized monoclonal antibody injectionA single dose (8 mg/kg) of HLX15 via intravenous infusion. | Drug | HLX15 group |
| US-sourced DARZALEX®Also: Daratumumab InjectionA single dose (8 mg/kg) of US-sourced DARZALEX® via intravenous infusion. | Drug | US-sourced DARZALEX® group |
| CN-sourced DARZALEX®Also: Daratumumab InjectionA single dose (8 mg/kg) of CN-sourced DARZALEX® via intravenous infusion. | Drug | CN-sourced DARZALEX® group |
| EU-sourced DARZALEX®Also: Daratumumab InjectionA single dose (8 mg/kg) of EU-sourced DARZALEX® via intravenous infusion. | Drug | EU-sourced DARZALEX® group |
Primary outcome
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf).
Time frame: Up to Day 91
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 last measurable concentration (AUC0-t);
Time frame: Up to Day 91
Maximum (peak) serum drug concentration (Cmax);
Time frame: Up to Day 91
Time to reach maximum (peak) serum drug concentration (Tmax);
Time frame: Up to Day 91
Volume of distribution during the terminal phase (Vz);
Time frame: Up to Day 91
Elimination half-life (t1/2);
Time frame: Up to Day 91
Total clearance (CL);
Time frame: Up to Day 91
Percentage of area under serum concentration-time curve obtained by extrapolation (%AUCex).
Time frame: Up to Day 91
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 28 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
RecruitingPhase 1/2
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
RecruitingObservational study
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Smoldering Multiple Myeloma
RecruitingPhase 1/2
Study of Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin in Multiple Myeloma
Multiple Myeloma
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX15, US-sourced DARZALEX® and CN-sourced DARZALEX® in people with Multiple Myeloma, run by Shanghai Henlius Biotech at 2 sites 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 5 inclusion and 19 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 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf). (time frame: Up to Day 91). 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 28 Jun 2024.