A Phase I Study of GenSci148 Intravitreal Injection for Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion (GenSci148-101)
A Phase I, Open-label, Dose-escalation, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intravitreal Injection of GenSci148 in Participants With Neovascular Age-related Macular Degeneration (nAMD) and Multiple Intravitreal Injections of GenSci148 in Participants With nAMD, Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase I, multicenter, open-label, dose-escalation study conducted in 2 parts to evaluate the safety, tolerability, PK and PD profiles, and immunogenicity, as well as the preliminary efficacy of intravitreal injection of GenSci148 in participants with nAMD, DME and RVO.
Part 1 (Single Ascending Dose, SAD): Conducted in participants with nAMD. Four dose levels (1 mg/eye, 3 mg/eye, 7 mg/eye, and 10 mg/eye) are planned, administered via a single IVT injection. Dose escalation is determined by the Safety Review Committee (SRC) based on safety, tolerability, PK, PD, and other available data.
Part 2 (Multiple Ascending Dose, MAD): Conducted in participants with nAMD, DME, and RVO. Three dose levels (low, medium, and high) are planned. Participants will receive multiple IVT injections according to the study schedule. Disease activity assessment will be performed during follow-up, and participants meeting retreatment criteria may receive additional doses of GenSci148.
Safety assessments include adverse events, physical examinations, laboratory tests, vital signs, ECG, and ophthalmic examinations (BCVA, IOP, slit-lamp examination, , etc.). PK/PD and immunogenicity samples are collected at predefined time points.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Gaohui Zhou
- Telefonnummer: +86-021-64320070
- E-mail: zhougaohui@genscigroup.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200080
- Shanghai General Hospital
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Kontakt:
- Xiaodong Sun
- Telefonnummer: +86 13386259752
- E-mail: xdsun@sjtu.edu.cn
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Able to understand the study and provide written informed consent prior to any study-related procedures.
- Willing and able to comply with scheduled visits, treatment plan, and study procedures.
- Best corrected visual acuity (BCVA) of 24 to 78 letters (inclusive) in the study eye, and BCVA ≥ 24 letters in the fellow eye.
Exclusion Criteria:
- Prior or current contraindicated ophthalmic treatments in study or fellow eye per protocol.
- Refractive error > ±8.0 diopters in the study eye.
- Anterior segment neovascularization or vitreous hemorrhage in the study eye.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: GenSci148 Intravitreal Injection
Participants receive intravitreal injections of GenSci148 at escalating dose levels.
Part 1: single ascending dose (1 mg, 3 mg, 7 mg, 10 mg per eye).
Part 2: multiple ascending doses in nAMD, DME, and RVO participants.
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GenSci148 is a fusion protein that simultaneously targets VEGF-A, VEGF-C, VEGF-D, and Ang-2.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Incidence and severity of treatment-emergent adverse events (TEAEs)
Tidsramme: 43 days(Part 1) and 40 weeks (Part 2)
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TEAEs include ocular and systemic adverse events, graded by severity and relationship to study drug.
Safety assessments include physical examination, vital signs, laboratory tests, ECG, and ophthalmic examinations.
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43 days(Part 1) and 40 weeks (Part 2)
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GenSci148-101
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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