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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 : February 22, 2024
Sponsor:
Information provided by (Responsible Party):
ABL Bio, Inc.

Tracking Information
First Submitted Date  ICMJE January 20, 2023
First Posted Date  ICMJE March 7, 2023
Last Update Posted Date February 22, 2024
Actual Study Start Date  ICMJE December 31, 2022
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2024)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2023)		 Incidence of Treatment-Emergent Adverse Events [ Time Frame: Day1 to Day113 ]
Number of participants with AEs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2024)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2023)
  • Assessment of pharmacokinetic(PK) parameter Cmax in serum [ Time Frame: Day1 to Day113 ]
    Maximum plasma concentration observed from Day1 to Day113
  • 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
  • Assessment of immunogenicity [ Time Frame: D1 to D113 ]
    Numbers of subjects with ADA(anti-drug antibody) positive from D1 to D113
  • Assessment of immunogenicity [ Time Frame: D1 to D113 ]
    Numbers of subjects with ADA(anti-drug antibody) negative from D1 to D113
Current Other Pre-specified Outcome Measures
 (submitted: February 21, 2024)		 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
Original Other Pre-specified Outcome Measures
 (submitted: March 6, 2023)		 Total alpha-synuclein in plasma [ Time Frame: Baseline through Day 113 ]
Plasma samples for PD analysis of ABL301 will be collected
 
Descriptive Information
Brief Title  ICMJE This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: ABL301
    SAD: Participants will receive a single dose of ABL301 IV infusion, MAD: Participants will receive multiple doses of ABL301 IV infusion
  • Drug: Placebo
    SAD: single Placebo IV infusion, MAD: multiple Placebo IV infusion
Study Arms  ICMJE
  • Experimental: ABL301
    Intervention: Drug: ABL301
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2024)		 86
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2023)		 40
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dayoung Ok +82-31-8018-9800 dayoung.ok@ablbio.com
Contact: Sangmi Lee sangmi.lee@ablbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05756920
Other Study ID Numbers  ICMJE ABL301-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: ABL Bio will not be sharing individual de-identified participant data or other relevant study documents.
Current Responsible Party ABL Bio, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ABL Bio, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ABL Bio, Inc.
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP