ABF-101 single and multiple ascending dose safety test in healthy adults and people with AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 program includes three parts: Parts A and B are randomized, double-blind, placebo-controlled cohorts that give single ascending doses (SAD) and multiple ascending doses (MAD) of ABF-101 to healthy adults, while Part C is an open-label cohort of participants with diagnosed AMD. Serial blood sampling in Parts A and B will measure pharmacokinetics and pharmacodynamics, and ocular exams across parts will monitor ocular structure and function. Safety and tolerability are the primary outcomes, with exploratory measures of ocular changes in the AMD cohort. The design uses placebo control and dose escalation to define a safe dose range before further testing in patient populations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Part A and B

  1. Healthy participants, aged between 18 and 50 years
  2. Provides written, signed, informed consent prior to selection
  3. BMI of ≥ 18.0 and \< 32.0 kg/m2, and body weight between 50 kg and 115 kg, inclusive.
  4. Vital signs: normal pulse rate and blood pressure.
  5. Nonsmoker
  6. Must be willing to abstain from caffeine and alcohol
  7. Must be willing to avoid strenuous activity
* Part C

  1. Confirmed diagnosis of AMD
  2. Male or female ≥50 years of age
  3. Adequate visual acuity in the non-study eye

Exclusion Criteria:

* Part A and B

  1. Any history or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease
  2. Any significant abnormalities detected during ocular examination,
  3. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
  4. Any drug intake (except paracetamol or contraceptives)
  5. History or presence alcohol abuse
  6. History or presence of drug abuse
  7. Positive HBsAg or anti-HCV antibody, or positive results for HIV
  8. Blood donation, significant blood loss, or has received a transfusion of any blood or blood products
  9. Female participants who are breastfeeding.
  10. 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
  11. 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

1. Evidence of CNV due to any cause other than AMD
2. History of vitreoretinal surgery
3. Significant ocular diseases that may interfere with the study
4. Significantly impaired renal or hepatic function
5. Use of immunosuppressive drugs
6. Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy
7. History of severe drug allergies or drug hypersensitivity syndrome
8. 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.
9. Severe cardiac disease.
10. QTc ≥450 msec or participants with a history of risk factors or other clinically significant ECG abnormalities
11. Stroke or transient ischemic attack
12. Any major surgical procedure w
13. 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
14. Presence of any condition which, in the judgment of the investigator, would prevent the participant from completing the study

Where it's running

• Dallas Clinical Research Unit
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Center, Clinical Center
• Email: cd@aptabio.com
• Phone: +82-31-365-3693

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How macular neovascular membrane type affects recovery after pneumatic displacement for macular hemorrhage

  This project will test if the type of macular neovascular membrane predicts vision and retinal recovery after pneumatic displacement in Caucasian patients aged 50 and over with submacular hemorrhage from AMD.

  Recruiting Azienda Sanitaria Universitaria Integrata del Trentino · Trento, Trento · NCT07427160

• Transplanting hiPSC-derived RPE Cells for Advanced AMD

  This trial tests whether transplanting lab-made retinal pigment epithelium cells can help people aged 50–85 with late-stage AMD see if their condition improves or stabilizes.

  Recruiting Phase 1/2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07418177

• My Eyes, My Light — community eye screening in Char Fasson

  This project tests whether a community-based screening program can find treatable eye problems in people aged 35 and older who live in Char Fasson, Bangladesh.

  Recruiting Data Yakka, Inc. · Char Fasson, Bhola · NCT07135570

• Evaluating visual rehabilitation's effects on anxiety and depression in patients with AMD

  This study is testing whether a visual rehabilitation program can help reduce anxiety and depression in people with advanced age-related macular degeneration.

  Recruiting Fondazione G.B. Bietti, IRCCS · Rome, Italy · NCT06906003

• Microcurrent therapy for advanced age-related macular degeneration

  This study is testing a new device that uses microcurrents to see if it can improve vision and eye health in people with advanced age-related macular degeneration.

  Recruiting at 11 sites i-Lumen Scientific AUS PTY LTD · Poway, California and 12 other locations · NCT06662162

• Enhanced vision and imaging tests to enable treatments for early and intermediate AMD

  We will see if a fundus-tracked dark adaptometry test can reliably detect and track vision changes in people with early or intermediate AMD and in healthy volunteers.

  Recruiting University Hospital, Bonn · Bonn · NCT07515521

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.