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A Pharmacokinetic Study of JS002 in Healthy Subjects

NCT05859529 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2024-09-05

No results posted yet for this study

Summary

This study was a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. Subjects were randomly assigned to 1 of 2 parallel treatment groups: treatment group A received a single subcutaneous injection of JS002 150 mg via PFS, and treatment group B received a single subcutaneous injection of JS002 150 mg via AI. Subjects were followed up to study day 85 for pharmacokinetic equivalence assessment of JS002. A total of 159 subjects were planned to be included in each group. After signing the informed consent form and completing the screening examination, subjects will be randomly assigned to treatment arm A or treatment arm B if eligible for inclusion.

The study period consisted of a screening period of up to 21 days and a follow-up period of 12 weeks (85 days). Subjects were admitted to the phase I clinical research unit the day before dose administration (day 1) and were not allowed to leave until all examinations and assessments were completed on day 6 after dose administration and were allowed to return to the clinical research center for follow-up visits on days 8,11,15,22,29,43,57,71, and 85.

Conditions

  • Health Volunteer

Interventions

DRUG

JS002

The drug was administered by a single subcutaneous injection

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2023-06-30
Completion
2023-09-11

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05859529 on ClinicalTrials.gov