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

Arcus Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AB680; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04575311

ARC-11

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Active: Dose Escalation

Active Comparator group

Description:

Participants will receive a single oral dose of AB680 at one of two ascending dose levels. Assignment to receive AB680 will be random.

Treatment:

Drug: AB680

Placebo: Dose Escalation

Placebo Comparator group

Description:

Participants will receive matching placebo as a single oral dose. Assignment to receive matching placebo will be random.

Treatment:

Other: Placebo