Healthy Subjects (HS)Phase 1NCT06633055
A Phase I Clinical Trial of JH013 Injection
A Phase 1 study testing JH013 injection in people with Healthy Subjects (HS), run by Biotech Pharmaceutical Co., Ltd..
Trial summary
This is a phase I clinical trial with a single dose escalation to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JH013 injection in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- JH013 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2024to 31 Dec 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female aged 18-55 years (age including cut-off values);
- There were no abnormalities in clinically significant vital signs, physical examination, laboratory tests, and 12-lead ECG;
- Weight ≥ 50 kg for males and ≥45 kg for females; Body mass index (BMI) between 18.0 and 26 kg/m2 (including cut-off values, body mass index = weight/height2);
- Females of potential childbearing potential with a negative blood β-HCG test within 72 hours prior to dosing (postmenopausal women who have amenorrhea for at least 12 months are considered non-childbearing and women who are known to have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or ligation, and a pregnancy test is not required);
- Subjects understand and comply with the study process, participate voluntarily, and sign the informed consent form
Who cannot join
- Subject has a history of malignancy prior to screening, or has been screened for malignancy, and the possibility of malignancy cannot be reasonably ruled out
- Subject has a history of autoimmune disease prior to screening
- γ interferon release assay results ≥ 2 times the upper limit of normal
- Any history of infection requiring hospitalization or receiving antivirals, antibiotics, antifungals, antiparasitic drugs, or vaccinations within 4 weeks prior to the application of the study drug
- Those who have positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody or syphilis antibody
- Patients with a history of previous and/or current heart disease (including New York Heart Association Class III/IV heart failure), gastrointestinal, renal, endocrine, neurological, autoimmune, hematologic (including pancytopenia, aplastic anemia or anaemia, etc.), metabolic (including diabetes), severe lung disease and psychiatric illness
- History of organ transplantation: such as heart, lung, kidney, liver, or hematopoietic stem cell transplantation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JH013 Injection in Healthy Subjects
This is a phase I clinical trial with a single dose escalation to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JH013 injection in healthy subjects
Read the detailed description
Four dose groups were set up, 75 mg, 150 mg, 300 mg, and 500 mg, respectively. Eight subjects (6 subjects received JH013 injection, 2 subjects received placebo) were planned to be included in each dose group for subcutaneous administration.The safety and tolerability within 48 hours after administration were first observed in each dose group with 2 subjects (1 subject receiving JH013 injection and 1 subject receiving placebo),after that, the remaining 6 subjects (5 receiving JH013 injection and 1 receiving placebo) were enrolled. Each subject may only participate in this trial in one dose group, and the next higher dose trial will only be allowed after it has been determined that the previous dose has been well safe and tolerated within 28 days of dosing (as determined by an independent, unblinded third-party physician in conjunction with the investigator and sponsor). When the safety evaluation meets the termination criteria during the dose escalation process, the dose between the dose group and the previous dose group can be returned if necessary after discussion by the investigator and the sponsor, and the maximum safe tolerated dose can be explored again. When the dose is escalated to the highest dose set by the protocol and the dose termination criteria are not met, it is up to the investigator and the sponsor to discuss whether to expand to a higher dose.
- Conditions
- Healthy Subjects (HS)
- Being tested
- JH013 injection, Placebo
- Keywords
- Dose escaltion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JH013 injectionDrug
Also called JH013
JH013 injection is a BAFF-R inhibitor monoclonal antibody
PlaceboDrug
Also called JH013 Placebo
JH013 injections placebo
| Study group | Role | What they receive |
|---|---|---|
| JH013 injections 75mg | Experimental | 6 subjects receive JH013 at a dose of 75 mg and 2 subjects receive the same volume placebo Receives: Drug: JH013 injection; Drug: Placebo |
| JH013 injections 150mg | Experimental | 6 subjects will receive JH013 injections 150mg，2 subjects receive the same volume placebo Receives: Drug: JH013 injection; Drug: Placebo |
| JH013 injections 300mg | Experimental | 6 subjects receive JH013 at a dose of 300 mg and 2 subjects receive the same volume placebo Receives: Drug: JH013 injection; Drug: Placebo |
| JH013 injections 500mg | Experimental | 6 subjects receive JH013 at a dose of 500 mg and 2 subjects receive the same volume placebo Receives: Drug: JH013 injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety metrics
Including Adverse events defined by CTCAE 5.0（Common Terminology Criteria for Adverse Events Version 5.0) Version 5.0）
Measured: from Administration to Day57.
Secondary outcomes (7)
t1/2
Half-life
Measured: from Administration to Day57.
Cmax
maximum plasma concentration
Measured: from Administration to Day57.
CD45+CD19+ B cell
Detection CD45+CD19+ B cell count and ratio in blood
Measured: from Administration to Day57.
B cell activation factor (BAFF)
Detection B cell activation factor (BAFF) in serum
Measured: from Administration to Day57.
JH013 antibody
Detection of JH013 antibody occupancy in serum
Measured: from Administration to Day57.
CD45+CD3+T cell
Detection of CD45+CD3+T cell count and ratio blood
Measured: from Administration to Day57.
Drug immunogenicity
Detection of anti-drug antibodies in serum
Measured: from Administration to Day57.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start31 Oct 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies of the same condition, open and under way.
- 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, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- chen Rui, Dr, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633055
- Sponsor's protocol ID
- BPL-JH013-HV-1001
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JH013 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06633055
- Acronym / sponsor ID
- BPL-JH013-HV-1001
- Conditions
- Healthy Subjects (HS)
- Keywords
- Dose escaltion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Oct 2024 (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 is a phase I clinical trial with a single dose escalation to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JH013 injection in healthy subjects
Detailed description
Four dose groups were set up, 75 mg, 150 mg, 300 mg, and 500 mg, respectively. Eight subjects (6 subjects received JH013 injection, 2 subjects received placebo) were planned to be included in each dose group for subcutaneous administration.The safety and tolerability within 48 hours after administration were first observed in each dose group with 2 subjects (1 subject receiving JH013 injection and 1 subject receiving placebo),after that, the remaining 6 subjects (5 receiving JH013 injection and 1 receiving placebo) were enrolled. Each subject may only participate in this trial in one dose group, and the next higher dose trial will only be allowed after it has been determined that the previous dose has been well safe and tolerated within 28 days of dosing (as determined by an independent, unblinded third-party physician in conjunction with the investigator and sponsor). When the safety evaluation meets the termination criteria during the dose escalation process, the dose between the dose group and the previous dose group can be returned if necessary after discussion by the investigator and the sponsor, and the maximum safe tolerated dose can be explored again. When the dose is escalated to the highest dose set by the protocol and the dose termination criteria are not met, it is up to the investigator and the sponsor to discuss whether to expand to a higher dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JH013 injections 75mg | Experimental | Drug: JH013 injection, Drug: Placebo6 subjects receive JH013 at a dose of 75 mg and 2 subjects receive the same volume placebo |
| JH013 injections 150mg | Experimental | Drug: JH013 injection, Drug: Placebo6 subjects will receive JH013 injections 150mg，2 subjects receive the same volume placebo |
| JH013 injections 300mg | Experimental | Drug: JH013 injection, Drug: Placebo6 subjects receive JH013 at a dose of 300 mg and 2 subjects receive the same volume placebo |
| JH013 injections 500mg | Experimental | Drug: JH013 injection, Drug: Placebo6 subjects receive JH013 at a dose of 500 mg and 2 subjects receive the same volume placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult male or female aged 18-55 years (age including cut-off values);
- There were no abnormalities in clinically significant vital signs, physical examination, laboratory tests, and 12-lead ECG;
- Weight ≥ 50 kg for males and ≥45 kg for females; Body mass index (BMI) between 18.0 and 26 kg/m2 (including cut-off values, body mass index = weight/height2);
- Females of potential childbearing potential with a negative blood β-HCG test within 72 hours prior to dosing (postmenopausal women who have amenorrhea for at least 12 months are considered non-childbearing and women who are known to have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or ligation, and a pregnancy test is not required);
- Subjects understand and comply with the study process, participate voluntarily, and sign the informed consent form
Key exclusion criteria (7 listed)
- Subject has a history of malignancy prior to screening, or has been screened for malignancy, and the possibility of malignancy cannot be reasonably ruled out
- Subject has a history of autoimmune disease prior to screening
- γ interferon release assay results ≥ 2 times the upper limit of normal
- Any history of infection requiring hospitalization or receiving antivirals, antibiotics, antifungals, antiparasitic drugs, or vaccinations within 4 weeks prior to the application of the study drug
- Those who have positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody or syphilis antibody
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 |
|---|---|---|
| JH013 injectionAlso: JH013JH013 injection is a BAFF-R inhibitor monoclonal antibody | Drug | JH013 injections 150mg, JH013 injections 300mg, JH013 injections 500mg, JH013 injections 75mg |
| PlaceboAlso: JH013 PlaceboJH013 injections placebo | Drug | JH013 injections 150mg, JH013 injections 300mg, JH013 injections 500mg, JH013 injections 75mg |
Primary outcome
Safety metrics
Time frame: from Administration to Day57.
Including Adverse events defined by CTCAE 5.0（Common Terminology Criteria for Adverse Events Version 5.0) Version 5.0）
7 secondary outcomes
t1/2
Time frame: from Administration to Day57.
Cmax
Time frame: from Administration to Day57.
CD45+CD19+ B cell
Time frame: from Administration to Day57.
B cell activation factor (BAFF)
Time frame: from Administration to Day57.
JH013 antibody
Time frame: from Administration to Day57.
CD45+CD3+T cell
Time frame: from Administration to Day57.
Drug immunogenicity
Time frame: from Administration to Day57.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- 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.
chen Rui, Dr principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JH013 injection in people with Healthy Subjects (HS), run by Biotech Pharmaceutical Co., Ltd..
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 7 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Wang Yucheng, Master (010-51571020, wangyucheng@biotechplc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety metrics (time frame: from Administration to Day57.). 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 9 Oct 2024.