A Phase 1 interventional study of JS005 in Health Volunteer, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 1, Interventional, and Treatment
This study is a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. After signing the informed consent form and completing the screening examination, if the subjects meet all the inclusion criteria and do not meet any exclusion criteria, they will be randomly assigned to treatment group A or treatment group B: treatment group A receives a single subcutaneous injection of JS005 300 mg through PFS, and treatment group B receives a single subcutaneous injection of JS005 300 mg through AI. Subjects were followed up until the 85th day of the study to evaluate the pharmacokinetic equivalence of JS005. 136 subjects are planned to be included in each group.
The entire study cycle includes a screening period of up to 21 days and a follow-up period of 12 weeks (85 days). Subjects will be admitted to the Phase I clinical research ward on the day before administration (D-1), and can only leave after completing all examinations and evaluations on the 11th day after administration. They will return to the clinical research center for follow-up on days 15, 22, 29, 43, 57, 71, and 85.
Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The drug was administered by a single subcutaneous injection via AI
Drug: JS005
The drug was administered by a single subcutaneous injection via PFS
Drug: JS005
JS005:The drug was administered by a single subcutaneous injection
AUC0-last
Area under the time-concentration curve from time 0 to last time of quantifiable concentration
Time frame: 85 days
Cmax
Maximum Concentration
Time frame: 85 days
AUC0-inf
Area under the time-concentration curve from time 0 to inf of quantifiable concentration
Time frame: 85 days
incidence and severity of adverse events(AE)
incidence and severity of adverse events(AE)
Time frame: 85 days
The time to reach Cmax (Tmax)
Pharmacokinetic (PK) parameters of JS005 :The time to receive reach Cmax (Tmax)
Time frame: 85 days
Apparent clearance(CL/F)
Apparent clearance(CL/F) of JS005 :apparent clearance(CL/F)
Time frame: 85 days
T1/2
Elimination half-life of JS005
Time frame: 85 days
Vz/F
Apparent volume of distribution of JS005
Time frame: 85 days
ADA
Incidence of anti-JS005 drug antibodies (ADA)
Time frame: 85 days
ADA-positive
Titers of ADA-positive samples
Time frame: 85 days
NAb
Incidence of neutralizing antibodies (NAb)
Time frame: 85 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Junshi Bioscience Co., Ltd.