First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSUNHO（China）BioPharmaceutical CO., Ltd.
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Sequential
Treatments tested in this trial
ISH0613 for injection
Drug80, 240, 480, 640 mg; i.v.
Placebo
Drug80, 240, 480, 640 mg; i.v.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: Single-ascending dose：ISH0613Experimental treatment 1 intervention
Group B: Single-ascending dose：PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-emergent adverse events as assessed by CTCAE v6.0
Time frame
baseline through day 572
Injection site reactions assessments
Time frame
baseline through day 57Secondary outcomes
1
Maximum observed serum concentration (Cmax)
Time frame
baseline through day 572
Time to reach maximum observed serum concentration (Tmax)
Time frame
baseline through day 573
AUC from time 0 to the time of the dosing interval (AUC0-t)
Time frame
baseline through day 574
AUC from time 0 to infinity (AUC₀-∞)
Time frame
baseline through day 57Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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