A Study of GensSci098 in Subjects With Active Thyroid Eye Disease
NCT Number: NCT06569758
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Safety|Tolerability|GenSci098|Thyroid Eye Disease (TED)
Interventions: DRUG: GenSci098|DRUG: GenSci098 Placebo
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-09
Completion Date: 2027-12-13
Locations: Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, 200011, China

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

Primary Outcome Measures: Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG])., SAD Part: 169 days, MAD Part: 253 days
Secondary Outcome Measures: PK parameters after single and multiple subcutaneous doses of GenSci098: maximum concentration at steady state (Cmax,ss);, SAD Part: 169 days, MAD Part: 253 days|PK parameters after single and multiple subcutaneous doses of GenSci098: minimum concentration at steady state (Cmin,ss);, SAD Part: 169 days, MAD Part: 253 days|PK parameters after single and multiple subcutaneous doses of GenSci098: time to maximum concentration at steady state (Tmax,ss);, SAD Part: 169 days, MAD Part: 253 days|PK parameters after single and multiple subcutaneous doses of GenSci098: average concentration at steady state (Cav,ss);, SAD Part: 169 days, MAD Part: 253 days|PK parameters after single and multiple subcutaneous doses of GenSci098: area under the concentration-time curve at steady state (AUC0-τ,ss);, SAD Part: 169 days, MAD Part: 253 days|PK parameters after single and multiple subcutaneous doses of GenSci098: apparent clearance CL/F, SAD Part: 169 days, MAD Part: 253 days|PK parameters after single and multiple subcutaneous doses of GenSci098: half life t1/2,, SAD Part: 169 days, MAD Part: 253 days|Incidences of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs), and titer of ADA., SAD Part: 169 days, MAD Part: 253 days
Other Outcome Measures: Changes from baseline in serum inflammatory cytokines including interleukin (IL)-6, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including interleukin IL-8,, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including monocyte chemotactic protein 1 (MCP-1), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including interleukin IL-4, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including interleukin IL-10, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including interleukin IL-12, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including interleukin IL-13, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including interleukin IL-17, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including interleukin IL-23, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including interleukin IL-1β, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including soluble interleukin-1 receptor antagonist (sIL-1RA), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including interferon γ (IFN γ), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including transforming growth factor β (TGF β), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including tumor necrosis factor α (TNF α), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including Chemokine(C-X-C Motif), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum inflammatory cytokines including Ligand 10 (CXCL-10, SAD Part: 169 days, MAD Part: 253 days|Change from Baseline in proptosis of the study eye，amount of protrusion of the eye from the orbital rim measured by Hertel exophthalmometer., SAD Part: 169 days, MAD Part: 253 days|Change from Baseline in CAS value of the study eye,composed spontaneous retrobulbar pain, pain on attempted upward or downward gaze,redness of eyelids,redness of conjunctiva,swelling of caruncle or plica,swelling of eyelids,swelling of conjunctiva., SAD Part: 169 days, MAD Part: 253 days|Change from Baseline in diplopia，Diplopia assessment will be performed using the Gorman score, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in GO-QoL., SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum thyrotropin receptor antibody (TRAb),, SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in thyroid-stimulating antibody (TSAb), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum total triiodothyronine (T3), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum total thyroxine (T4), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum free triiodothyronine (FT3), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum free thyroxine (FT4), SAD Part: 169 days, MAD Part: 253 days|Changes from baseline in serum thyroid-stimulating hormone (TSH), SAD Part: 169 days, MAD Part: 253 days