ABF-101 for Age-Related Macular Degeneration
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the safety and tolerability of a new treatment, ABF-101, for individuals with age-related macular degeneration (AMD). It consists of two parts: healthy participants will receive the treatment to evaluate how their bodies respond, while those with AMD will take it to determine its safety and effects on their condition. Individuals with a confirmed AMD diagnosis and good vision in one eye may qualify for the AMD segment of the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you must stop taking your current medications, but it does exclude participants using immunosuppressive drugs or any investigational agents. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that ABF-101 is likely to be safe for humans?
Research shows that ABF-101 is in the early testing phase, focusing on its safety and how the body processes it. Since it is in Phase 1 trials, the researchers have not yet determined how well people tolerate it or if there are any serious side effects. This phase checks safety in both healthy individuals and those with age-related macular degeneration (AMD).
Testing on humans indicates that earlier lab tests did not reveal major safety concerns. Currently, detailed safety information from these studies is unavailable. Participants should remember that this stage primarily confirms safety and assesses how well people tolerate the treatment.12345Why do researchers think this study treatment might be promising?
Researchers are excited about ABF-101 for age-related macular degeneration (AMD) because it offers a new approach compared to current treatments like anti-VEGF injections. Unlike these standard treatments, ABF-101 is administered orally as a capsule, which could make it more convenient for patients. Furthermore, ABF-101 is designed to target AMD differently, potentially offering an innovative mechanism of action that could enhance or complement existing therapies. This new method of delivery and action could represent a significant advancement in the management of AMD.
What evidence suggests that ABF-101 might be an effective treatment for age-related macular degeneration?
Research is investigating ABF-101 as a potential treatment for age-related macular degeneration (AMD). This trial consists of different parts: Part A and Part B, where participants may receive either ABF-101 or a placebo, and Part C, an open-label study where all participants receive ABF-101. While direct evidence on ABF-101's effectiveness for AMD is not yet available, understanding its mechanism is crucial. ABF-101 targets the root issues of AMD, often involving the growth of abnormal blood vessels in the eye. This approach resembles existing treatments like bevacizumab, which have successfully managed AMD. Initial studies focus on the safety of ABF-101 and its pharmacokinetics, an essential first step before assessing its effectiveness. Early indications of its mechanism are promising, but further research is necessary to confirm its benefits.14678
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-50 with normal vital signs, a BMI of 18.0 to less than 32.0 kg/m2, and weighing between 50-115 kg who don't smoke and agree to avoid caffeine, alcohol, and strenuous activity. It also includes those diagnosed with age-related macular degeneration (AMD).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD)
Participants receive a single oral dose of ABF-101 or placebo in a randomized, double-blind, placebo-controlled manner
Multiple Ascending Dose (MAD)
Participants receive multiple oral doses of ABF-101 or placebo in a randomized, double-blind, placebo-controlled manner
Open-label Study
Participants with AMD receive ABF-101 in an open-label manner
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABF-101
Trial Overview
The study tests ABF-101's safety and effects on the body compared to a placebo in both healthy participants and those with AMD. The trial will look at how the body processes the drug (pharmacokinetics) and its impact on disease markers (pharmacodynamics).
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
* Part C will be an open-label study in participants with AMD * Capsule, once daily by mouth
* Part B (Phase 1b) will be a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study in healthy participants. * Capsule, once daily by mouth
* Part A (Phase 1a) will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants. * Capsule, single oral dose
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aptabio Therapeutics, Inc.
Lead Sponsor
Citations
A Phase 1 Study of ABF-101 in Single- and Multiple- ...
This is a Phase 1 study to evaluate the safety, tolerability, PK, and PD of ABF-101 in healthy participants and participants with age-related macular ...
5-Year Outcomes with Anti-VEGF Treatment of ...
Purpose. To describe outcomes 5 years after initiation of treatment with bevacizumab or ranibizumab for neovascular age-related macular degeneration (AMD).
Real-world outcomes in patients with neovascular age ...
Twelve-month outcomes of ranibizumab vs. Aflibercept for neovascular age-related macular degeneration: data from an observational study. Ophthalmology, 123 ...
Gene and cell therapy for age-related macular degeneration
The reported data successfully met the primary endpoints, demonstrating the ophthalmic and systemic safety of AVA-101; however, the secondary.
Recent Advances in Age-Related Macular Degeneration ...
This review aims to bring together the most recent advances and insights into the mechanisms underlying AMD pathogenicity and disease evolution.
ABF-101 - Drug Targets, Indications, Patents
A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101.
Gene therapy for neovascular age-related macular degeneration
AVA-101 was shown to be safe, thereby leading to an expansion phase, with 32 patients randomised to either the 1011 vg cohort or the ...
Anti‐vascular endothelial growth factor for neovascular age ...
The aim of this Cochrane review was to compare treatment with anti‐vascular endothelial growth factor (anti‐VEGF) agents for neovascular age‐related macular ...
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