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

Официальное название

A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101

Обзор

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).

Подробное описание

Part A will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants.

Part B will be a randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study in healthy participants.

Part C will be an open-label study in participants with AMD. For Part A and B, serial blood samples will be collected to assess the PK of ABF-101. Ocular examinations will be conducted to evaluate changes in ocular characteristics and function.

Вмешательства

• Препарат ABF-101
  orally, QD
• Препарат Placebo
  orally, QD

Первичные конечные точки

• Number of Participants with treatment-emergent adverse event [Срок оценки: From enrollment up to 12 weeks]

Вторичные конечные точки (4)

• Maximum Observed Plasma Concentration (Cmax) of ABF-101 [Срок оценки: From enrollment up to 12 weeks]
• Time to maximal concentration (Tmax) of ABF-101 [Срок оценки: From enrollment up to 12 weeks]
• The plasma area under the curve (AUC) of ABF-101 [Срок оценки: From enrollment up to 12 weeks]
• Terminal elimination half-life of ABF-101 [Срок оценки: From enrollment up to 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Dallas Clinical Research Unit — Dallas

Идентификаторы

NCT: NCT07330674 · ABF-101-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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