A Study of GenSci098 in Subjects With Active Thyroid Eye Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
About this trial
To evaluate the safety and tolerability of single and multiple ascending subcutaneous doses of GenSci098 in patients with thyroid eye disease (TED)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At the time of signing the informed consent form (ICF): aged between 18 and 75 years (inclusive).
Diagnosed by the physician as having active TED associated with Graves' disease (GD), based on clinical and laboratory test results, with a CAS ≥ 3 (on the 7-point scale) for the most severely affected eye at screening and baseline.
Onset of active symptoms and signs of TED (including one or more of the following: redness of conjunctiva, swelling of conjunctiva (chemosis), redness of eyelids, swelling of eyelids, swelling of caruncle or plica, spontaneous retrobulbar pain, and pain on attempted upward or downward gaze) within 12 months prior to the screening visit.
Positive for thyroid stimulating hormone receptor antibodies (TRAb) at screening.
Disqualifiers
Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 or more lines on the Snellen chart or standard logarithmic chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
Corneal injury not relieved by medical management.
Improvement in CAS of ≥ 2 points within 1 month prior to screening or between screening and baseline.
Decrease in proptosis of ≥ 2 mm within 1 month prior to screening or between screening and baseline.
Trial design
Design model
Sequential
Treatments tested in this trial
GenSci098
Drugsubcutaneous , 5 dose levels(15mg, 45mg, 90mg, 180mg and 270mg) will be assigned.
GenSci098 Placebo
DrugIn 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: GenSci098Experimental treatment 1 intervention
Group B: GenSci098 PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events (AEs) (physical examination, vital signs, laboratory tests, 12-lead electrocardiogram [ECG]).
Time frame
SAD Part: 169 days, MAD Part: 281 daysSecondary outcomes
1
PK parameters after single and multiple subcutaneous doses of GenSci098: maximum concentration at steady state (Cmax,ss);
Time frame
SAD Part: 169 days, MAD Part: 281 days2
PK parameters after single and multiple subcutaneous doses of GenSci098: minimum concentration at steady state (Cmin,ss);
Time frame
SAD Part: 169 days, MAD Part: 281 days3
PK parameters after single and multiple subcutaneous doses of GenSci098: time to maximum concentration at steady state (Tmax,ss);
Time frame
SAD Part: 169 days, MAD Part: 281 days4
PK parameters after single and multiple subcutaneous doses of GenSci098: average concentration at steady state (Cav,ss);
Time frame
SAD Part: 169 days, MAD Part: 281 daysOther outcomes
1
Changes from baseline in serum inflammatory cytokines including interleukin (IL)-6
Time frame
SAD Part: 169 days, MAD Part: 281 days2
Changes from baseline in serum inflammatory cytokines including interleukin IL-8,
Time frame
SAD Part: 169 days, MAD Part: 281 days3
Changes from baseline in serum inflammatory cytokines including monocyte chemotactic protein 1 (MCP-1)
Time frame
SAD Part: 169 days, MAD Part: 281 days4
Changes from baseline in serum inflammatory cytokines including interleukin IL-4
Time frame
SAD Part: 169 days, MAD Part: 281 daysSponsors and contacts
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Source ClinicalTrials.gov