STSA-1002 subcutaneous injection: dose 1 (First cohort) for Granulomatosis with polyangiitis

Phase 1

Waitlist Available

Led By Martin K Kankam, Doctor

Research Sponsored by Staidson (Beijing) Biopharmaceuticals Co., Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called STSA-1002, which is given as an injection under the skin. It involves healthy volunteers to check if the drug is safe and well-tolerated. Researchers will also study how the drug moves through and affects the body.

Eligible Conditions

Granulomatosis with polyangiitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Abnormal clinical laboratory values as assessed by toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (blood hematology, blood chemistry, urinalysis, etc.)

Abnormal electrocardiogram (ECG): heart rate, PR and QT intervals, QTcF and QRS duration

Abnormal physical examination

+12 more

Secondary study objectives

Change from baseline in concentration of free C5a

anti-drug antibody