Healthy Subjects (HS)Phase 1NCT07516639
First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
A Phase 1 study testing ISH0613 for injection in people with Healthy Subjects (HS) and SLE (Systemic Lupus), run by SUNHO（China）BioPharmaceutical CO., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults. This study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose. The main questions this study aims to answer are: I. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS), SLE (Systemic Lupus)
- What is being tested?
- ISH0613 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese adult subjects, male or female, aged 18 to 45 years (inclusive);
- Body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive); body weight generally ≥50 kg for males and ≥45 kg for females;
- Male subjects and their partners, or female subjects, must agree to use at least one effective non-pharmacological contraceptive method (e.g., complete abstinence, intrauterine device, partner sterilization) during the study period, and must have no plan for sperm or egg donation;
- Subjects are able to fully understand the purpose, nature, and procedures of the study, including potential adverse reactions, and voluntarily sign the informed consent form (ICF);
- Subjects are able to communicate well with the investigator and are willing and able to comply with all study procedures and requirements.
Who cannot join
- Known allergy to the investigational product or any of its excipients, or a history of hypersensitivity to monoclonal antibodies;
- History or presence of clinically significant diseases of the cardiovascular, endocrine, nervous, gastrointestinal, respiratory, genitourinary, hematological, immunological, psychiatric, or metabolic systems, or any other condition that may interfere with study results, as judged by the investigator;
- Clinically significant abnormalities in laboratory tests (hematology, urinalysis, biochemistry, coagulation) or auxiliary examinations (chest X-ray, abdominal ultrasound);
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus (HIV) antibody, or syphilis antibody;
- Receipt of any surgical procedure within 6 months prior to signing the informed consent form, or planned surgery (including cosmetic, dental, or oral surgery) within 2 weeks after the end of the study;
- Alcohol consumption exceeding 14 units per week within 3 months prior to screening (1 unit = 360 mL beer, 150 mL wine, or 45 mL liquor), or positive alcohol breath test at screening or baseline, or inability to abstain from alcohol during the study;
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- Average smoking of more than 5 cigarettes per day within 3 months prior to screening;
- History of drug abuse, use of soft drugs (e.g., cannabis) within 3 months prior to screening, or use of hard drugs (e.g., cocaine, phencyclidine) within 1 year prior to screening, or positive drug abuse screening test (including morphine, ketamine, THC-COOH, methamphetamine, MDMA, cocaine);
- Habitual excessive intake within 4 weeks prior to screening of caffeine-containing beverages or foods or substances that may affect drug metabolism, such as coffee (>1100 mL/day), tea (>2200 mL/day), cola (>2200 mL/day), energy drinks (>1100 mL/day), or chocolate (>510 g/day);
- Use of any prescription drugs, over-the-counter medications, or traditional Chinese medicines within 14 days prior to dosing;
- Receipt of any monoclonal antibody therapy within 6 months prior to dosing;
- Vaccination within 3 months prior to dosing, or planned vaccination during the study period;
- Participation in another clinical trial and receipt of investigational drug treatment within 3 months prior to dosing;
- Blood donation or significant blood loss (>400 mL, excluding menstrual loss) within 3 months prior to screening, or receipt of blood transfusion or blood products, or planned blood donation during the study period or within 1 month after study completion;
- Pregnant or lactating women;
- Clinically significant abnormal vital signs (systolic blood pressure <90 mmHg or ≥140 mmHg; diastolic blood pressure <55 mmHg or ≥90 mmHg; heart rate <50 bpm or >100 bpm; body temperature <35.4°C or >37.3°C), or clinically significant ECG abnormalities (QTcF >450 ms for males, >470 ms for females), or clinically significant findings on physical examination, as judged by the investigator;
- Presence of infection requiring treatment for acute or chronic infection, including but not limited to:
- Herpes zoster within 12 months prior to screening;
- Current suppressive therapy for chronic infections (e.g., tuberculosis, Pneumocystis, cytomegalovirus, herpes simplex virus, varicella-zoster virus, or atypical mycobacteria);
- History of tuberculosis or contact with active tuberculosis within 6 months prior to screening, or positive T-SPOT test;
- Parasitic infection within 3 months prior to dosing;
- Hospitalization due to infectious disease within 30 days prior to dosing;
- Parenteral anti-infective treatment (including antibacterial, antiviral, antifungal, or antiparasitic agents) within 30 days prior to dosing;
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210000
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase Ia First-in-Human Study to Evaluate the Single Intravenous Administration of ISH0613 in Healthy Subjects
The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults.
This study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose.
Read more
The main questions this study aims to answer are:
- What medical problems (side effects) may occur after receiving ISH0613? How does ISH0613 move through and get processed in the body? II. Does ISH0613 affect certain biological markers related to the immune system? III. Researchers will compare ISH0613 to a placebo (a look-alike substance that contains no active drug) to better understand its effects.
Participants will:
- Receive a single intravenous infusion of either ISH0613 or placebo II. Stay in the clinical unit for several days for close monitoring after dosing III. Return to the clinic for follow-up visits over several weeks IV. Provide blood samples for safety checks and laboratory testing V. Be monitored for any side effects throughout the study
- Conditions
- Healthy Subjects (HS), SLE (Systemic Lupus)
- Being tested
- ISH0613 for injection, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISH0613 for injectionDrug
80, 240, 480, 640 mg; i.v.
PlaceboDrug
80, 240, 480, 640 mg; i.v.
| Study group | Role | What they receive |
|---|---|---|
| Single-ascending dose：ISH0613 | Experimental | Not described Receives: Drug: ISH0613 for injection |
| Single-ascending dose：Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events as assessed by CTCAE v6.0
Measured: baseline through day 57
Injection site reactions assessments
Measured: baseline through day 57
Secondary outcomes (9)
Maximum observed serum concentration (Cmax)
Measured: baseline through day 57
Time to reach maximum observed serum concentration (Tmax)
Measured: baseline through day 57
AUC from time 0 to the time of the dosing interval (AUC0-t)
Measured: baseline through day 57
AUC from time 0 to infinity (AUC₀-∞)
Measured: baseline through day 57
Terminal elimination half-life (t1/2)
Measured: baseline through day 57
Apparent clearance after extravascular administration (CL/F)
Measured: baseline through day 57
Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F)
Measured: baseline through day 57
Serum immunoglobulin levels (IgG, IgA, IgM)
Measured: baseline through day 57
B cell count
Measured: baseline through day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by SUNHO（China）BioPharmaceutical CO., Ltd.The 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516639
- Sponsor's protocol ID
- ISH0613-101
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase Ia First-in-Human Study to Evaluate the Single Intravenous Administration of ISH0613 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07516639
- Acronym / sponsor ID
- ISH0613-101
- Conditions
- Healthy Subjects (HS), SLE (Systemic Lupus)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2026 (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.
The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults.
This study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose.
The main questions this study aims to answer are:
- What medical problems (side effects) may occur after receiving ISH0613? How does ISH0613 move through and get processed in the body? II. Does ISH0613 affect certain biological markers related to the immune system? III. Researchers will compare ISH0613 to a placebo (a look-alike substance that contains no active drug) to better understand its effects.
Participants will:
- Receive a single intravenous infusion of either ISH0613 or placebo II. Stay in the clinical unit for several days for close monitoring after dosing III. Return to the clinic for follow-up visits over several weeks IV. Provide blood samples for safety checks and laboratory testing V. Be monitored for any side effects throughout the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-ascending dose：ISH0613 | Experimental | Drug: ISH0613 for injection |
| Single-ascending dose：Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Chinese adult subjects, male or female, aged 18 to 45 years (inclusive);
- Body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive); body weight generally ≥50 kg for males and ≥45 kg for females;
- Male subjects and their partners, or female subjects, must agree to use at least one effective non-pharmacological contraceptive method (e.g., complete abstinence, intrauterine device, partner sterilization) during the study period, and must have no plan for sperm or egg donation;
- Subjects are able to fully understand the purpose, nature, and procedures of the study, including potential adverse reactions, and voluntarily sign the informed consent form (ICF);
- Subjects are able to communicate well with the investigator and are willing and able to comply with all study procedures and requirements.
Key exclusion criteria (24 listed)
- Known allergy to the investigational product or any of its excipients, or a history of hypersensitivity to monoclonal antibodies;
- History or presence of clinically significant diseases of the cardiovascular, endocrine, nervous, gastrointestinal, respiratory, genitourinary, hematological, immunological, psychiatric, or metabolic systems, or any other condition that may interfere with study results, as judged by the investigator;
- Clinically significant abnormalities in laboratory tests (hematology, urinalysis, biochemistry, coagulation) or auxiliary examinations (chest X-ray, abdominal ultrasound);
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus (HIV) antibody, or syphilis antibody;
- Receipt of any surgical procedure within 6 months prior to signing the informed consent form, or planned surgery (including cosmetic, dental, or oral surgery) within 2 weeks after the end of the study;
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 |
|---|---|---|
| ISH0613 for injection80, 240, 480, 640 mg; i.v. | Drug | Single-ascending dose：ISH0613 |
| Placebo80, 240, 480, 640 mg; i.v. | Drug | Single-ascending dose：Placebo |
Primary outcome
Number of participants with treatment-emergent adverse events as assessed by CTCAE v6.0
Time frame: baseline through day 57
Injection site reactions assessments
Time frame: baseline through day 57
9 secondary outcomes
Maximum observed serum concentration (Cmax)
Time frame: baseline through day 57
Time to reach maximum observed serum concentration (Tmax)
Time frame: baseline through day 57
AUC from time 0 to the time of the dosing interval (AUC0-t)
Time frame: baseline through day 57
AUC from time 0 to infinity (AUC₀-∞)
Time frame: baseline through day 57
Terminal elimination half-life (t1/2)
Time frame: baseline through day 57
Apparent clearance after extravascular administration (CL/F)
Time frame: baseline through day 57
Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F)
Time frame: baseline through day 57
Serum immunoglobulin levels (IgG, IgA, IgM)
Time frame: baseline through day 57
B cell count
Time frame: baseline through day 57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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.
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 ISH0613 for injection in people with Healthy Subjects (HS) and SLE (Systemic Lupus), run by SUNHO（China）BioPharmaceutical CO., Ltd. 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 5 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: opening soon, as of the sponsor's last update on 13 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ya Ze Jiao (15950520087, 15950520087@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events as assessed by CTCAE v6.0 (time frame: baseline through day 57). 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 13 Apr 2026.