First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics (NCT07516639) | Clinical Trial Compass
Not Yet RecruitingPhase 1
First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
China26 participantsStarted 2026-04-01
Plain-language 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. 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:
I. 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
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-emergent adverse events as assessed by CTCAE v6.0
. 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;
. 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);