A Multi-center, Open-Label, Phase 1, Single- and Multiple Ascending Dose Study to Assess Safety and Tolerability of PMC-403 in Subjects With Neovascular Age-related Macular Degeneration (nAMD).

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a Phase 1 study, first-in-human (FIH), open label study to evaluate the safety, tolerability and identify the maximum tolerated dose (MTD) of PMC-403 and determine the recommended phase 2 dose (RP2D).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
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∙ To be eligible for study participation, subjects must meet all of the following inclusion criteria.

∙ \* Criteria for the selection of the study eye

∙ If both eyes meet the criteria, the study eye will be selected according to the following criteria:

• The eye with lower (severer) best corrected visual acuity (BCVA) at baseline will be selected as the study eye.

• If both eyes have the same BCVA, the right eye will be selected as the study.

‣ Male and female ≥50 years of age at the time of written informed consent.

⁃ Treatment required, based on the judgment of the investigator, due to insufficient therapeutic efficacy despite ≥ 3 repeated doses of anti-vascular endothelial growth factor (anti-VEGF) intravitreal injection (IVT) for nAMD in the study eye, and the subject's agreement to receive the study drug instead of conventional standard therapy

⁃ \>12 weeks must have elapsed since the last dose of anti-VEGF IVT at the time of screening.

⁃ Active subfoveal or parafoveal choroidal neovascularization (CNV)\* confirmed by fundus fluorescein angiography (FFA), spectral domain-optical coherence tomography (SD-OCT), and IndoCyanine Green (ICG) angiography.

‣ \*Active CNV (confirmed by the central reading center) is defined as the presence of subretinal fluid (SRF) or intraretinal fluid (IRF) in consequence of vascular leakage.

⁃ The size of the entire lesion in the study eye (including blood, atrophy, fibrosis, and neovascularization) must be ≤ 9-disc areas, and the area of CNV in the study eye must account for ≥ 50% of the total area of the lesion, as confirmed by FFA and ICG angiography.

⁃ BCVA measured in the study eye must be between ≥ 23 letters and ≤ 78 letters based on the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (Snellen visual acuity 20/25 - 20/320).

⁃ Voluntary written informed consent to study participation.

Locations
Other Locations
Republic of Korea
Yeungnam University
RECRUITING
Daegu
ASAN Medical Center
RECRUITING
Seoul
Seoul National University Bundang Hospital
RECRUITING
Seoul
Yonsei University Health System
RECRUITING
Seoul
Contact Information
Primary
Hyojin Koh
hyojin.koh@pharmabcine.com
070-4213-2925
Backup
Surin Park
surin.park@pharmabcine.com
070-4446-3031
Time Frame
Start Date: 2023-07-20
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 36
Treatments
Experimental: PART 1- SAD
The SAD part of the study will be conducted in a step-wise manner for a total of 4 dose levels of PMC-403.~* Dose level 1: 0.7 mg/eye, baseline(Day 0)~* Dose level 2: 2 mg/eye, baseline(Day 0)~* Dose level 3: 3 mg/eye, baseline(Day 0)~* Dose level 4: 4 mg/eye, baseline(Day 0)
Experimental: PART 2- MAD
Upon the end of the SAD part of the study, the MAD part is planned to be conducted in a step-wise manner for a total of 2 dose levels.~* Dose level 1: 3 mg/eye, baseline(Day 0), Week 4(Day 28), Week 8(Day 56)~* Dose level 2: 4 mg/eye, baseline(Day 0), Week 4(Day 28), Week 8(Day 56)
Sponsors
Collaborators: C&R Research, Inc.
Leads: PharmAbcine

This content was sourced from clinicaltrials.gov