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

Official title

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

Overview

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).

Detailed description

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (4)

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

Eligibility criteria

Inclusion 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Dallas Clinical Research Unit — Dallas

Identifiers

NCT: NCT07330674 · ABF-101-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗