A Phase I Clinical Trial of JH013 Injection
ConditionHealthy Subjects (HS)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBiotech Pharmaceutical Co., Ltd.
About this trial
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
Eligibility criteria
Qualifiers
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);
Disqualifiers
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
Trial design
Treatments tested in this trial
- JH013 injection
- Placebo
Treatment groups
32 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov