Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT02461771
Phase
PHASE1
Status
Completed

Conditions

  • Neovascular Age-Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pegcetacoplan — DRUG
    On treatment day, subjects will be administered a single 100 μL IVT injection of pegcetacoplan at the dose corresponding to their treatment assignment.

Study Details

The objective of this study is to provide initial safety, tolerability and pharmacokinetics information of intravitreal administration of pegcetacoplan in order to support further development into larger Phase II studies for treatment of patients with AMD.

Key Dates

Start date
Jan 28, 2015
Status verified
Sep 2020
Primary completion
Mar 8, 2016
Completion
Mar 8, 2016

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pegcetacoplan Cohort 1
    4 mg of pegcetacoplan 100 μL IVT injection
  • Experimental: Pegcetacoplan Cohort 2
    10 mg of pegcetacoplan 100 μL IVT injection
  • Experimental: Pegcetacoplan Cohort 3
    20 mg of pegcetacoplan 100 μL IVT injection

Primary Outcome Measure

Number of Subjects Who Experienced Ocular and Systemic Adverse Events (AEs), Including by Severity [ Time Frame: Day 1 to Day 113 ]

Locations (3)

FacilityCityStateZIPSite coordinators
United States, CaliforniaBeverly HillsCalifornia90211-
United States, FloridaMiamiFlorida33136-
United States, New HampshirePortsmouthNew Hampshire03801-

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