ABL301 for Healthy Subjects

Overseen By Sangmi Lee

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ABL Bio, Inc.

Disqualifiers: Cardiovascular disease, Malignancy, Psychiatric disorder, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new treatment called ABL301 in healthy adults. Researchers seek to understand how the body processes ABL301, which involves administering a single dose through an IV infusion. Two groups will participate: one receiving ABL301 and the other a placebo (a substance with no active drug). The trial seeks healthy adults without a history of heart issues or frequent headaches. Participants should feel comfortable with medical exams and agree to follow the trial guidelines. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that ABL301 is likely to be safe for humans?

Research has shown that ABL301 is safe and well-tolerated. Previous studies reported no serious side effects, with most being mild and low in severity. In one study, only 7.1% of participants experienced treatment-related side effects, and notably, half of these occurred in the placebo group. This data suggests that ABL301 is generally safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ABL301 because it presents a novel approach by being administered through a single-dose IV infusion, potentially offering a more consistent delivery compared to standard oral medications. Unlike traditional treatments that often focus on symptom management, ABL301 might target the underlying mechanisms more directly, which could result in enhanced efficacy. Additionally, the unique formulation of ABL301 could mean fewer side effects, making it a promising option for those seeking alternatives to current therapies.

What evidence suggests that ABL301 could be effective?

Research shows that ABL301, also known as SAR446159, is being tested primarily for safety and tolerance in healthy adults. This special type of antibody targets the brain and interacts with alpha-synuclein, a protein linked to Parkinson's disease. Although its effectiveness in treating any condition remains unknown, the goal is to remove harmful proteins from the brain. Early studies found it to be safe, marking an important first step. Further research is needed to determine its potential benefits for conditions like Parkinson's. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Healthy adults aged 18-55, with a body weight of at least 50 kg and BMI between 19-30 kg/m2 can join this trial. They must be in good health based on medical history, lab tests, physical exams, vital signs, and ECG results. Participants should not have frequent headaches or migraines, any cancer within the last five years (except certain skin cancers), significant heart issues or allergies as determined by the investigator.

Inclusion Criteria

I weigh at least 50 kg and my BMI is between 19 and 30.

Participant agrees to comply with all protocol requirements

Participant is considered by the investigator to be in good health based on medical history, clinical tests, physical and neurological examination, vital signs, and ECG

Exclusion Criteria

I often have headaches, migraines, or I vomit more than twice a month.

I have a history of heart problems, including high blood pressure or irregular heartbeat.

I have not had any psychiatric disorders, suicidal thoughts in the last 6 months, or any suicide attempts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of ABL301 or placebo

16 weeks

Multiple visits for dose administration and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of ABL301 or placebo

24 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABL301
• Placebo

Trial Overview

The study is testing ABL301 against a placebo to evaluate its safety and how it's processed by the body (pharmacokinetics) and its effects on the body's response (pharmacodynamics). It's a first-in-human study where participants are randomly assigned to receive either ABL301 or placebo in single ascending doses (SAD) and multiple ascending doses (MAD).

How Is the Trial Designed?

Group I: ABL301 Experimental Treatment 1 Intervention

The single doses of ABL301 will be administered via IV infusion

Group II: Placebo Placebo Group 1 Intervention

The single doses of placebo will be administered via IV infusion.

Who Is Running the Clinical Trial?

ABL Bio, Inc.

Lead Sponsor

Trials

6

Recruited

390+

Citations

1.

ablbio.com

ablbio.com/en/company/news_view/877?keyword=

News

According to the clinical study report, ABL301 (SAR446159) demonstrated safety and tolerability in both the SAD and MAD studies, with no deaths ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05756920

NCT05756920 | This is a Study to Evaluate the Safety, ...

This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants. ClinicalTrials.gov ID NCT05756920.

3.

med.stanford.edu

med.stanford.edu/content/dam/sm/parkinsons/documents/Updates-in-parkinsons-therapy-2025.pdf

Updates in Therapeutics for Parkinson's Disease

Phase 2 Results: The study found that patients treated with risvodetinib had improvements in both the severity of their symptoms. (measured by MDS-UPDRS) and ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12373799/

A brain-shuttled antibody targeting alpha synuclein ...

A Phase I clinical trial to evaluate the safety, tolerability, PK, and PD of IV administered SAR446159 in health volunteers was initiated (NCT05756920).

5.

linkedin.com

linkedin.com/posts/ablbio_abl301-pakrinson-activity-7368099408875327488-4EVt

ABL Bio confirms safety of ABL301 for Parkinson's disease

... healthy adults. According to the clinical study report, ABL301 (SAR446159) demonstrated safety and tolerability with no deaths or serious ...

6.

biz.chosun.com

biz.chosun.com/en/en-science/2025/09/01/T4B4JV5P2JBYLK3446GOZBFESY/

ABL Bio confirms ABL301's safety in U.S. Phase 1 trial for ...

As a result, no serious adverse reactions were observed, and most adverse reactions were confirmed to be mild, at grades 1 to 2.

7.

koreabiomed.com

koreabiomed.com/news/articleView.html?idxno=28799

ABL Bio clears FDA phase 1 safety test for Sanofi- ... - KBR

In the single-dose arm, 7.1 percent of participants reported treatment-related adverse events, but half were in the placebo group. Roughly 70 ...

8.

nature.com

nature.com/articles/d43747-020-00409-5

Blood–brain barrier molecular carriers for Parkinson's ...

ABL301 thus combines specificity for SNCA with safe and efficient BBB penetrance. “Existing antibody therapeutics penetrate the brain with only 0.1–0.2% ...