A Study to Investigate the Safety of 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

NCT03677973

AB680CSP0001

Details and patient eligibility

About

This is a double-blind, randomized, placebo-controlled, single- and multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetic profile of AB680 in healthy volunteers.

Full description

AB680 will be administered as single and multiple intravenous doses to the healthy volunteers. In each group of 8 participants, 6 will receive AB680 and 2 will receive matching placebo.

The participants will be closely observed to monitor the general tolerability of AB680.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 55 years, inclusive, at screening
• Body mass index 18 to 30 kg/m2
• 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: Quadruple Blind

---

64 participants in 2 patient groups, including a placebo group

Active: Dose Escalation

Active Comparator group

Description:

Healthy volunteers will receive AB680 as a single intravenous (IV) infusion at 7 dose levels and as multiple IV infusions at 1 dose level. Assignment to receive AB680 or matching placebo will be random.

Treatment:

Drug: AB680

Placebo: Dose Escalation

Placebo Comparator group

Description:

Healthy volunteers will receive matching placebo as a single IV infusion and as multiple IV infusions. Assignment to receive AB680 or matching placebo will be random.

Treatment:

Other: Placebo