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

• Sponsor: ABL Bio, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05756920
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.7
• Patients Per Site Per Month: 4.6

Study Details

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.

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

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Single ascending doseSingle 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: Dec 31, 2022
• Anticipated Primary Completion Date: Sep 21, 2023
• Anticipated Study Completion Date: Sep 21, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Incidence of Treatment-Emergent Adverse Events [Day1 to Day113]

   Number of participants with AEs

Secondary Outcome Measures

1. Assessment of pharmacokinetic(PK) parameter Cmax in serum [Day1 to Day113]

   Maximum plasma concentration observed from Day1 to Day113

2. Assessment of pharmacokinetic(PK) parameter AUClast in serum [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 [D1 to D113]

   Numbers of subjects with ADA(anti-drug antibody) positive from D1 to D113

4. Assessment of immunogenicity [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 [Baseline through Day 113]

   Plasma samples for PD analysis of ABL301 will be collected

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	PPD Development, LP	Austin	Texas	United States	78744

Sponsors and Collaborators

• ABL Bio, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ABL Bio, Inc.
• ClinicalTrials.gov Identifier: NCT05756920
• Other Study ID Numbers: ABL301-1001
• First Posted: Mar 7, 2023
• Last Update Posted: Mar 7, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 7, 2023