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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06004921

Acronym

ARC-26

Enrollment

Registered

2023-08-22

Start date

2023-10-16

Completion date

2024-02-23

Last updated

2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

AB801, Healthy volunteer

Brief summary

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.

Interventions

DRUGAB801

Administered as specified in the treatment arm

DRUGPlacebo

Administered as specified in the treatment arm

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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/

Design outcomes

Primary

Measure	Time frame
Half-Life Time (t1/2)	Predose, Up to 120 hours postdose
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

Secondary

Measure	Time frame
Change from Baseline in Holter Electrocardiogram Monitoring Scale	Predose up to 25 hours postdose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026