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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05756920
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : March 7, 2023
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 in healthy adult participants.

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

Detailed Description:
The five single doses are planned to be administered in an ascending manner: DL1, DL2, DL3, DL4, and DL5. 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single ascending dose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Randomized, Placebo-Controlled, Double-Blind, Single-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 : September 21, 2023
Estimated Study Completion Date : September 21, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: ABL301
The single doses of ABL301 will be administered via IV infusion
 Drug: ABL301
single dose, IV infusion
Placebo Comparator: Placebo
The single doses of placebo will be administered via IV infusion.
 Drug: Placebo
single dose, IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Day1 to Day113 ]
    Number of participants with AEs


Secondary Outcome Measures :
  1. Assessment of pharmacokinetic(PK) parameter Cmax in serum [ Time Frame: Day1 to Day113 ]
    Maximum plasma concentration observed from Day1 to Day113

  2. Assessment of pharmacokinetic(PK) parameter AUClast in serum [ Time Frame: Day1 to Day113 ]
    Area under the plasma concentration versus time curve from time zero to the real time tlast from Day1 to Day113

  3. Assessment of immunogenicity [ Time Frame: D1 to D113 ]
    Numbers of subjects with ADA(anti-drug antibody) positive from D1 to D113

  4. Assessment of immunogenicity [ Time Frame: D1 to D113 ]
    Numbers of subjects with ADA(anti-drug antibody) negative from D1 to D113


Other Outcome Measures:
  1. Total alpha-synuclein in plasma [ Time Frame: Baseline through Day 113 ]
    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.
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: March 7, 2023
Last Verified: March 2023
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