CompletedNCT05756920Updated Jul 23, 2025

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

A Phase 1 interventional study of ABL301 and Placebo in Healthy, sponsored by ABL Bio, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by ABL Bio, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Apr 2025, 1 year 5 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 91
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK and PD after SAD and MAD in healthy adult participants.

Read the detailed description

The present study is the first administration of ABL301 in humans. This study will evaluate safety and tolerability and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of ABL301, following IV single ascending dose (Part 1 - SAD), and multiple ascending dose (Part 2 - MAD) administrations, in healthy adult participants.

In Part 1 SAD, seven single doses are planned to be administered in an ascending manner: DL1, DL2, DL3, DL4, DL5, DL6 and DL7. Each dose level will comprise 8 participants randomly assigned in an overall 6:2 ratio (ABL301:Placebo), including 1:1 ratio for the first 2 sentinel participants and 5:1 ratio for the remaining participants, to receive a single dose of study drug or placebo, respectively.

In Part 2 MAD, three multiples doses are planned to be administered in an ascending manner: DL1, DL2 and DL3. Each dose level will comprise 10 participants randomly assigned in an overall 8:2 ratio (ABL301:Placebo)

Conditions studied

Healthy

In context

Lead sponsor

ABL Bio, Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

The participant is considered by the investigator to be in good health as determined by medical history, clinical laboratory test results (including urinalysis), physical and neurological examination, vital signs, and ECG.
The participant agrees to comply with all protocol requirements.
The participant is a healthy male or female 18 to 55 years of age, inclusive.
The participant has body weight ≥50 kg and a BMI of 19 to 30 kg/m2, inclusive.

Exclusion criteria

Exclusion Criteria:

The participant has a history of cardiovascular disease (eg, hypertension, arrhythmia, heart failure, long QT syndrome, or other conditions/diseases causing prolongation of the QT/QTcF).
The participant has a past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT interval syndrome prior to initial dosing.
The participant has frequent headaches and/or migraine or recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
The participant has history of malignancy including solid tumors and hematologic malignancies within 5 years prior to the screening visit (except basal cell and squamous cell carcinomas of the skin that had been completely excised and were considered cured).
The participant has a history of clinically significant drug or food allergies, as determined by the investigator.
(MAD only) The participant has a current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the C SSRS), or a lifetime suicide attempt.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 91 participants (actual)

Study arms

Experimental
ABL301
Drug: ABL301
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugABL301
SAD: Participants will receive a single dose of ABL301 IV infusion, MAD: Participants will receive multiple doses of ABL301 IV infusion
DrugPlacebo
SAD: single Placebo IV infusion, MAD: multiple Placebo IV infusion

What researchers measure

Primary outcomes

Incidence of Treatment-Emergent Adverse Events
Number of participants with AEs
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part

Secondary outcomes

Assessment of pharmacokinetic(PK) parameter Cmax in serum
Maximum plasma concentration observed
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of pharmacokinetic(PK) parameter AUClast in serum
Area under the plasma concentration versus time curve from time zero to the real time tlast
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of immunogenicity
Numbers of subjects with ADA(anti-drug antibody) positive
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of immunogenicity
Numbers of subjects with ADA(anti-drug antibody) negative
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of pharmacokinetic(PK) parameter AUCtau in serum (MAD only)
Area under the serum concentration time curve over the dosing interval
Time frame: D1 to Day 169 for MAD Part

Other outcomes

Total alpha-synuclein in plasma
Plasma samples for PD analysis of ABL301 will be collected
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part

Study locations

1 site

PPD Development, LP
Austin, Texas 78744, United States

References and documents

Individual participant data

Plan to share: No — ABL Bio will not be sharing individual de-identified participant data or other relevant study documents.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05756920
Lead sponsor: ABL Bio, Inc.
Responsible party: Sponsor
First posted: Mar 7, 2023
Start date: Dec 31, 2022
Primary completion: Apr 30, 2025
Completion: Apr 30, 2025
Last update: Jul 23, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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