Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients with NAMD (phase I Portion)

Phase 1

Not yet recruiting

• Conditions: NAMD
• Interventions: Drug: SCT520FF

• Registration Number: NCT06672536
• Lead Sponsor: Sinocelltech Ltd.

Brief Summary

Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Status Verified: 2025-02
• Study Start: 2025-02-14
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2026-09-23
• Study Completion: 2027-01-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Signed informed consent form.
2. Age≥45 years, ≤80 years，male or femal.
3. The study eye must meet the following criteria: Diagnosis of nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73~19 letters.

Exclusion Criteria

1. Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.
2. Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.
3. Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.
4. The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine.
5. MNV caused by non-nAMD exists in the study eye .
6. Active inflammation or infection in either eye before randomization.
7. Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.
8. Abnormal liver and kidney function.
9. Poorly-controlled blood pressure before randomization.
10. History of a cardiovascular and cerebrovascular events, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, etc) within 6 months before randomization.
11. Evidence of significant uncontrolled concomitant diseases.
12. Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) before randomization and have used the test drug or received device treatment.
13. Pregnant, lactating women who can not take contraceptive measures during the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SCT520FF dose level 1 treatment	SCT520FF	SCT520FF dose level 1(0.625mg),IVI,injection once every 4 weeks,three times continuously
SCT520FF dose level 3 treatment	SCT520FF	SCT520FF dose level 3(2.5mg),IVI,injection once every 4 weeks,three times continuously
SCT520FF dose level 2 treatment	SCT520FF	SCT520FF dose level 2(1.25mg),IVI,injection once every 4 weeks,three times continuously

Primary Outcome Measures

Name	Time	Method
Treatment emergent adverse events(TEAE)	From Day 0 up to 196days	Incidence of treatment emergent adverse events
Treatment-related treatment emergent adverse events(TRAE)	From Day 0 up to 196days	Incidence of treatment-related treatment emergent adverse events
Serious adverse event(SAE)	From Day 0 up to 196days	Incidence of serious adverse event
Adverse event of special interest(AESI)	From Day 0 up to 196days	Incidence of adverse event of special interest
Dose limited toxicity(DLT)	From Day 0 up to 196days	Incidence of dose-limiting toxicities

Secondary Outcome Measures

Name	Time	Method
Cmax	Day 0 up to 196days	The maximum blood concentration after SCT520FF drug enters the bloodstream
Tmax	Day 0 up to 196days	Time to the Maximum Concentration of SCT520FF
PD profile	Day 0 up to 196 days	Detection of free VEGF concentration
Immunogenicity	Day 0 up to 196days	Positive rate of ADA and NAb
Best corrected visual acuity(BCVA)	Day 0 up to 196 days	Mean change from baseline in BCVA
central retina thickness(CRT)	Day 0 up to 196days	Mean change from baseline in CRT
PK profile	Day 0 up to 196days	Change of SCT520FF drug concentration in the blood with time