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

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ClinicalTrials.gov Identifier: NCT05756920
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : February 22, 2024
Sponsor:
Information provided by (Responsible Party):
ABL Bio, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: ABL301 Drug: Placebo Phase 1

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single Ascending Dose and Multiple Ascending Dose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Randomized, A Phase 1 Randomized, Placebo Controlled, Double Blind, Two Part, Single- and Multiple-Ascending-Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered ABL301 in Healthy Adult Participants
Actual Study Start Date : December 31, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: ABL301 Drug: ABL301
SAD: Participants will receive a single dose of ABL301 IV infusion, MAD: Participants will receive multiple doses of ABL301 IV infusion
Placebo Comparator: Placebo Drug: Placebo
SAD: single Placebo IV infusion, MAD: multiple Placebo IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part ]
    Number of participants with AEs


Secondary Outcome Measures :
  1. Assessment of pharmacokinetic(PK) parameter Cmax in serum [ Time Frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part ]
    Maximum plasma concentration observed

  2. Assessment of pharmacokinetic(PK) parameter AUClast in serum [ Time Frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part ]
    Area under the plasma concentration versus time curve from time zero to the real time tlast

  3. Assessment of immunogenicity [ Time Frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part ]
    Numbers of subjects with ADA(anti-drug antibody) positive

  4. Assessment of immunogenicity [ Time Frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part ]
    Numbers of subjects with ADA(anti-drug antibody) negative

  5. Assessment of pharmacokinetic(PK) parameter AUCtau in serum (MAD only) [ Time Frame: D1 to Day 169 for MAD Part ]
    Area under the serum concentration time curve over the dosing interval


Other Outcome Measures:
  1. Total alpha-synuclein in plasma [ Time Frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part ]
    Plasma samples for PD analysis of ABL301 will be collected


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05756920


Contacts
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Contact: Dayoung Ok +82-31-8018-9800 dayoung.ok@ablbio.com
Contact: Sangmi Lee sangmi.lee@ablbio.com

Locations
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United States, Texas
PPD Development, LP Recruiting
Austin, Texas, United States, 78744
Contact: Gabriel Garcia    877-773-3707      
Principal Investigator: Brian Spears, MD         
Sponsors and Collaborators
ABL Bio, Inc.
More Information
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Responsible Party: ABL Bio, Inc.
ClinicalTrials.gov Identifier: NCT05756920    
Other Study ID Numbers: ABL301-1001
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: ABL Bio will not be sharing individual de-identified participant data or other relevant study documents.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No