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

Primary Purpose

Healthy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABL301
Placebo
Sponsored by
ABL Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • PPD Development, LPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ABL301

Placebo

Arm Description

The single doses of ABL301 will be administered via IV infusion

The single doses of placebo will be administered via IV infusion.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
Number of participants with AEs

Secondary Outcome Measures

Assessment of pharmacokinetic(PK) parameter Cmax in serum
Maximum plasma concentration observed from Day1 to Day113
Assessment of pharmacokinetic(PK) parameter AUClast in serum
Area under the plasma concentration versus time curve from time zero to the real time tlast from Day1 to Day113
Assessment of immunogenicity
Numbers of subjects with ADA(anti-drug antibody) positive from D1 to D113
Assessment of immunogenicity
Numbers of subjects with ADA(anti-drug antibody) negative from D1 to D113

Full Information

First Posted
January 20, 2023
Last Updated
March 6, 2023
Sponsor
ABL Bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05756920
Brief Title
This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2022 (Actual)
Primary Completion Date
September 21, 2023 (Anticipated)
Study Completion Date
September 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ABL Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Single ascending dose
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABL301
Arm Type
Experimental
Arm Description
The single doses of ABL301 will be administered via IV infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The single doses of placebo will be administered via IV infusion.
Intervention Type
Drug
Intervention Name(s)
ABL301
Intervention Description
single dose, IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single dose, IV infusion
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Number of participants with AEs
Time Frame
Day1 to Day113
Secondary Outcome Measure Information:
Title
Assessment of pharmacokinetic(PK) parameter Cmax in serum
Description
Maximum plasma concentration observed from Day1 to Day113
Time Frame
Day1 to Day113
Title
Assessment of pharmacokinetic(PK) parameter AUClast in serum
Description
Area under the plasma concentration versus time curve from time zero to the real time tlast from Day1 to Day113
Time Frame
Day1 to Day113
Title
Assessment of immunogenicity
Description
Numbers of subjects with ADA(anti-drug antibody) positive from D1 to D113
Time Frame
D1 to D113
Title
Assessment of immunogenicity
Description
Numbers of subjects with ADA(anti-drug antibody) negative from D1 to D113
Time Frame
D1 to D113
Other Pre-specified Outcome Measures:
Title
Total alpha-synuclein in plasma
Description
Plasma samples for PD analysis of ABL301 will be collected
Time Frame
Baseline through Day 113

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dayoung Ok
Phone
+82-31-8018-9800
Email
dayoung.ok@ablbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sangmi Lee
Email
sangmi.lee@ablbio.com
Facility Information:
Facility Name
PPD Development, LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Garcia
Phone
877-773-3707
First Name & Middle Initial & Last Name & Degree
Brian Spears, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
ABL Bio will not be sharing individual de-identified participant data or other relevant study documents.

Learn more about this trial

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

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