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A Study of GenSci098 in Subjects With Active Thyroid Eye Disease

NCT06569758 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-02-11

No results posted yet for this study

Summary

To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)

Conditions

  • Safety
  • Tolerability
  • GenSci098
  • Thyroid Eye Disease (TED)

Interventions

DRUG

GenSci098

subcutaneous , 5 dose levels(15mg, 45mg, 90mg, 180mg and 270mg) will be assigned.

DRUG

GenSci098 Placebo

In SAD part only one dose of GenSci098 and GenSci098 Placebo to be given, in MAD part, multiple doses of GenSci098 and GenSci098 Placebo will be given.

Sponsors & Collaborators

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Huifang Zhou, PHD · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2027-09-02
Completion
2027-12-13
FDA Drug
Yes

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 NCT06569758 on ClinicalTrials.gov