A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers

Study Overview
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Brief Summary
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The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in healthy volunteers.

Official Title
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A Phase 1, Double-Blinded, Randomised, Placebo-Controlled, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of AB801

Conditions
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Cancer

Intervention / Treatment
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* Drug: AB801
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Healthy as determined by medical evaluation by study physician Body mass index (BMI) of 18.0 to 32.0 kilogram (kg)/meter (m)^2 as measured at screening Weight ≥ 50 kg at screening Must agree to adhere to the protocol defined contraception requirements Key Exclusion Criteria: Do not have suitable veins for multiple venepunctures/cannulation as assessed by the study physician Prolonged QT interval defined as mean Corrected QT interval by Fridericia's formula (QTcF) ≥ 450 msec for males and > 470 millisecond (msec) for females at screening and pre-dose Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the study physician Received any study medicine in a clinical research study within the last 90 days Taking, or have taken, any prescribed or over-the-counter drugs including gastric acid reducing agents and including CYP3A inhibitor and/or inducers Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 - AB801 Dose A<br>Participants will receive a single dose of AB801 or placebo | Drug: AB801<br>* Administered as specified in the treatment arm<br>Drug: Placebo<br>* Administered as specified in the treatment arm<br>|
| Experimental: Cohort 2 - AB801 Dose B<br>Participants will receive a single dose of AB801 or placebo | Drug: AB801<br>* Administered as specified in the treatment arm<br>Drug: Placebo<br>* Administered as specified in the treatment arm<br>|
| Experimental: Cohort 3 - AB801 Dose C<br>Participants will receive a single dose of AB801 or placebo | Drug: AB801<br>* Administered as specified in the treatment arm<br>Drug: Placebo<br>* Administered as specified in the treatment arm<br>|
| Experimental: Cohort 4 - AB801 Dose D<br>Participants will receive a single dose of AB801 or placebo | Drug: AB801<br>* Administered as specified in the treatment arm<br>Drug: Placebo<br>* Administered as specified in the treatment arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) |  | Up to 30 days | 
| Area Under the Plasma Drug Concentration-Time Curve (AUC) |  | Predose, Up to 120 hours postdose | 
| Maximum Concentration (Cmax) in Plasma |  | Predose, Up to 120 hours postdose | 
| Time to Maximum Concentration (Tmax) in Plasma |  | Predose, Up to 120 hours postdose | 
| Half-Life Time (t1/2) |  | Predose, Up to 120 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Holter Electrocardiogram Monitoring Scale |  | Predose up to 25 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AB801, Healthy volunteer