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

NCT05756920 | Completed Phase 1 FDA Drug

• 1 other identifier: ABL301-1001
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Number of participants with AEs

  Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part

Secondary Outcomes (5)

• Assessment of pharmacokinetic(PK) parameter Cmax in serum

  Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part

• Assessment of pharmacokinetic(PK) parameter AUClast in serum

  Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part

• Assessment of immunogenicity

  Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part

• Assessment of immunogenicity

  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)

  D1 to Day 169 for MAD Part

Other Outcomes (1)

• Total alpha-synuclein in plasma

  Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part

Study Arms (2)

ABL301

EXPERIMENTAL

Drug: ABL301

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ABL301 DRUG

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

ABL301

Placebo DRUG

SAD: single Placebo IV infusion, MAD: multiple Placebo IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ABL Bio, Inc.: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Ascending Dose and Multiple Ascending Dose

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: March 7, 2023
• Study Start: December 31, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)