NCT06569758

A Study of GenSci098 in Subjects With Active Thyroid Eye Disease

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Subcutaneous Doses of GenSci098 in TED Patients

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Type	Name	Description
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.

Timeline

• Start date: 2024-09-24
• Primary completion: 2027-09-02
• Completion: 2027-12-13
• First posted: 2024-08-26
• Last updated: 2026-02-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study