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New treatment option for Age Related Macular Degeneration (ARMD)
Official title A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses
ClinicalTrials.gov ID: NCT07330674
What this study is testing
What is ABF-101?
ABF-101 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for age related macular degeneration (armd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 degeneration (AMD).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Part A and B
- Healthy participants, aged between 18 and 50 years
- Provides written, signed, informed consent prior to selection
- BMI of ≥ 18.0 and \< 32.0 kg/m2, and body weight between 50 kg and 115 kg, inclusive.
- Vital signs: normal pulse rate and blood pressure.
You likely can't join if
- Part A and B
- Any history or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic...
- Any significant abnormalities detected during ocular examination,
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
- Any drug intake (except paracetamol or contraceptives)
- History or presence alcohol abuse
See the full eligibility criteria
- Part A and B
- Healthy participants, aged between 18 and 50 years
- Provides written, signed, informed consent prior to selection
- BMI of ≥ 18.0 and \< 32.0 kg/m2, and body weight between 50 kg and 115 kg, inclusive.
- Vital signs: normal pulse rate and blood pressure.
- Nonsmoker
- Must be willing to abstain from caffeine and alcohol
- Must be willing to avoid strenuous activity
- Part C
- Confirmed diagnosis of AMD
- Male or female ≥50 years of age
- Adequate visual acuity in the non-study eye
- Part A and B
- Any history or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease
- Any significant abnormalities detected during ocular examination,
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
- Any drug intake (except paracetamol or contraceptives)
- History or presence alcohol abuse
- History or presence of drug abuse
- Positive HBsAg or anti-HCV antibody, or positive results for HIV
- Blood donation, significant blood loss, or has received a transfusion of any blood or blood products
- Female participants who are breastfeeding.
- Female participants must not be pregnant or at risk to become pregnant during the study. Male and female participants must agree to use highly effective contraception
- Participant who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language barrier or poor mental development Part C
- Evidence of CNV due to any cause other than AMD
- History of vitreoretinal surgery
- Significant ocular diseases that may interfere with the study
- Significantly impaired renal or hepatic function
- Use of immunosuppressive drugs
- Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy
- History of severe drug allergies or drug hypersensitivity syndrome
- Undiagnosed acute illness first observed during screening or between screening and baseline, or severe concurrent medical conditions that, in the investigator's judgment, represent a safety concern.
- Severe cardiac disease.
- QTc ≥450 msec or participants with a history of risk factors or other clinically significant ECG abnormalities
- Stroke or transient ischemic attack
- Any major surgical procedure w
- Serious active infection, other serious medical condition or any other condition that would impair the ability of the participant to administer the investigational drug or to adhere to the study protocol requirements
- Presence of any condition which, in the judgment of the investigator, would prevent the participant from completing the study
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.