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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ABL301
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Single ascending dose
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABL301<br>The single doses of ABL301 will be administered via IV infusion | Drug: ABL301<br>* single dose, IV infusion<br>|
| Placebo Comparator: Placebo<br>The single doses of placebo will be administered via IV infusion. | Drug: Placebo<br>* single dose, IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Number of participants with AEs | Day1 to Day113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetic(PK) parameter Cmax in serum | Maximum plasma concentration observed from Day1 to Day113 | 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 | Day1 to Day113 | 
| Assessment of immunogenicity | Numbers of subjects with ADA(anti-drug antibody) positive from D1 to D113 | D1 to D113 | 
| Assessment of immunogenicity | Numbers of subjects with ADA(anti-drug antibody) negative from D1 to D113 | D1 to D113 |