A Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Placebo; Drug: AB680

• Registration Number: NCT04575311
• Lead Sponsor: Arcus Biosciences, Inc.

Brief Summary

A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.

Detailed Description

The study will evaluate minimum of 2 dose levels of AB680 in 8 participants per cohort. Cohorts will be gender-balanced to the extent possible, and will be randomized 3:1, active vs placebo, respectively.

The participants will be closely observed for the first 48 hours following drug administration to monitor the general tolerability of AB680.

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Study Start: 2020-10-20
• Primary Completion: 2021-09-22
• Study Completion: 2021-09-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Male or female participants aged 18 to 55 years, inclusive, at screening
• Body mass index 18 to 32 kilograms/m^2 inclusive
• Willing and able to sign informed consent
• Negative tests for hepatitis B surface antigen, anti-hepatitis C virus, and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
• Healthy as determined by pre-study screening

Exclusion Criteria

• History of clinically significant drug and/or food allergies
• Positive drug and alcohol screen at screening and (each) admission to the clinical research center.
• Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to (the first) drug administration in the current study
• Participants who have significant infection or known inflammatory process on screening or admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo: Dose Escalation	Placebo	Participants will receive matching placebo as a single oral dose. Assignment to receive matching placebo will be random.
Active: Dose Escalation	AB680	Participants will receive a single oral dose of AB680 at one of two ascending dose levels. Assignment to receive AB680 will be random.

Primary Outcome Measures

Name	Time	Method
AB680 Peak Plasma Concentration (Cmax)	Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680	Cmax as measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis.
Area under the plasma concentration-time curve from time zero to t hours (AUC 0-t) of AB680	Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
AB680 Time of Peak Concentration (Tmax)	Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680	Tmax as measured by the Time to Maximum Concentration-Time Curve from Plasma Collection and Analysis

Secondary Outcome Measures

Name	Time	Method
Number of participants with Treatment Emergent Adverse Events (TEAEs)	From First Dose Date to 15 Days After the Last Dose of AB680	Number of participants with TEAEs as assessed by CTCAE v5.0.

Trial Locations

Locations (1)

Nucleus Network; 🇦🇺 Melbourne, Victoria, Australia