Age Related Macular Degeneration (ARMD)Phase 1NCT07330674
A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses
A Phase 1 study testing ABF-101 in people with Age Related Macular Degeneration (ARMD) and AMD - Age-Related Macular Degeneration, run by Aptabio Therapeutics, Inc. at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration (ARMD), AMD - Age-Related Macular Degeneration
- What is being tested?
- ABF-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dallas Clinical Research Unit
Dallas, Texas, 75247
Monica Lopez
About this study
Official title: A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101
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).
Read the 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.
- Being tested
- ABF-101, Placebo
- Keywords
- ABF-101, AMD, NOX
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABF-101Drug
orally, QD
PlaceboDrug
orally, QD
| Study group | Role | What they receive |
|---|---|---|
| Part A (ABF-101 or Placebo) | Experimental | * Part A (Phase 1a) will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants.
* Capsule, single oral dose Receives: Drug: ABF-101; Drug: Placebo |
| Part B (ABF-101 or Placebo) | Experimental | * Part B (Phase 1b) will be a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study in healthy participants.
* Capsule, once daily by mouth Receives: Drug: ABF-101; Drug: Placebo |
| Part C (ABF-101) | Experimental | * Part C will be an open-label study in participants with AMD
* Capsule, once daily by mouth Receives: Drug: ABF-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with treatment-emergent adverse event
To investigate the safety and tolerability of single ascending dose of ABF-101orally administered in healthy participants (Part A and B) and in AMD (Part C)
Measured: From enrollment up to 12 weeks
Secondary outcomes (4)
Maximum Observed Plasma Concentration (Cmax) of ABF-101
Assessment of the maximum observed plasma concentration
Measured: From enrollment up to 12 weeks
Time to maximal concentration (Tmax) of ABF-101
Assessment of time to maximal concentration
Measured: From enrollment up to 12 weeks
The plasma area under the curve (AUC) of ABF-101
Assessment of the plasma area under the curve
Measured: From enrollment up to 12 weeks
Terminal elimination half-life of ABF-101
Assessment of terminal elimination half-life
Measured: From enrollment up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular Degeneration (ARMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aptabio Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330674
- Sponsor's protocol ID
- ABF-101-01
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101
- ClinicalTrials.gov ID
- NCT07330674
- Acronym / sponsor ID
- ABF-101-01
- Keywords
- ABF-101, AMD, NOX
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Aptabio Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A (ABF-101 or Placebo) | Experimental | Drug: ABF-101, Drug: Placebo* Part A (Phase 1a) will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants. * Capsule, single oral dose |
| Part B (ABF-101 or Placebo) | Experimental | Drug: ABF-101, Drug: Placebo* Part B (Phase 1b) will be a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study in healthy participants. * Capsule, once daily by mouth |
| Part C (ABF-101) | Experimental | Drug: ABF-101* Part C will be an open-label study in participants with AMD * Capsule, once daily by mouth |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Part A and B
- Part C
Key exclusion criteria (27 listed)
- Part A and B
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABF-101orally, QD | Drug | Part A (ABF-101 or Placebo), Part B (ABF-101 or Placebo), Part C (ABF-101) |
| Placeboorally, QD | Drug | Part A (ABF-101 or Placebo), Part B (ABF-101 or Placebo) |
Primary outcome
Number of Participants with treatment-emergent adverse event
Time frame: From enrollment up to 12 weeks
To investigate the safety and tolerability of single ascending dose of ABF-101orally administered in healthy participants (Part A and B) and in AMD (Part C)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABF-101 in people with Age Related Macular Degeneration (ARMD) and AMD - Age-Related Macular Degeneration, run by Aptabio Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Center, Clinical Center (+82-31-365-3693, cd@aptabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with treatment-emergent adverse event (time frame: From enrollment up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.