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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • JH013 injection

    Drug

    JH013 injection is a BAFF-R inhibitor monoclonal antibody

  • Placebo

    Drug

    JH013 injections placebo

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: JH013 injections 75mgExperimental treatment 2 interventions
Group B: JH013 injections 150mgExperimental treatment 2 interventions
Group C: JH013 injections 300mgExperimental treatment 2 interventions
Group D: JH013 injections 500mgExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety metrics

Including Adverse events defined by CTCAE 5.0（Common Terminology Criteria for Adverse Events Version 5.0) Version 5.0）

Time frame
from Administration to Day57.

Secondary outcomes

1

t1/2

Half-life

Time frame
from Administration to Day57.
2

Cmax

maximum plasma concentration

Time frame
from Administration to Day57.
3

CD45+CD19+ B cell

Detection CD45+CD19+ B cell count and ratio in blood

Time frame
from Administration to Day57.
4

B cell activation factor (BAFF)

Detection B cell activation factor (BAFF) in serum

Time frame
from Administration to Day57.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biotech Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: