A Phase I Clinical Trial of JH013 Injection (NCT06633055) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Clinical Trial of JH013 Injection
32 participantsStarted 2024-10-31
Plain-language 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
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)…