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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756920
• Other study ID #: ABL301-1001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 31, 2022
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: ABL Bio, Inc.
• Contact: Dayoung Ok
• Phone: +82-31-8018-9800
• Email: dayoung.ok[@]ablbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	PPD Development, LP	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ABL Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total alpha-synuclein in plasma	Plasma samples for PD analysis of ABL301 will be collected	Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Primary	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	Assessment of pharmacokinetic(PK) parameter Cmax in serum	Maximum plasma concentration observed	Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Secondary	Assessment of pharmacokinetic(PK) parameter AUClast in serum	Area under the plasma concentration versus time curve from time zero to the real time tlast	Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Secondary	Assessment of immunogenicity	Numbers of subjects with ADA(anti-drug antibody) positive	Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Secondary	Assessment of immunogenicity	Numbers of subjects with ADA(anti-drug antibody) negative	Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Secondary	Assessment of pharmacokinetic(PK) parameter AUCtau in serum (MAD only)	Area under the serum concentration time curve over the dosing interval	D1 to Day 169 for MAD Part