A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses

Korábbi kezelés

• 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
• Use of immunosuppressive drugs
• Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy
• 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.
• 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

Más betegség

• History of vitreoretinal surgery
• Significant ocular diseases that may interfere with the study
• History of severe drug allergies or drug hypersensitivity syndrome
• Severe cardiac disease.
• Stroke or transient ischemic attack
• Presence of any condition which, in the judgment of the investigator, would prevent the participant from completing the study

Laborértékek

• QTc ≥450 msec or participants with a history of risk factors or other clinically significant ECG abnormalities

Egyéb

• Evidence of CNV due to any cause other than AMD
• Significantly impaired renal or hepatic function

• 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