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Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection

NCT05027373 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-08-30

No results posted yet for this study

Summary

This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody injection in Healthy Subjects. Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.

Conditions

  • Systemic Juvenile Idiopathic Arthritis
  • Periodic Fever Syndrome

Interventions

DRUG

SSGJ-613

SSGJ-613 injection is 200mg/2mL solution in a single vial.The solution is a clear to slightly opalescent, colorless to a slightly yellow tint.

DRUG

Placebo

Placebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless.

Sponsors & Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-08-13
Primary Completion
2022-04-30
Completion
2022-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05027373 on ClinicalTrials.gov