A Study to Investigate the Safety of AB680 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03677973

Enrollment

Registered

2018-09-19

Start date

2018-10-16

Completion date

2019-08-19

Last updated

2024-05-24

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

Conditions

Healthy Volunteers

Brief summary

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.

Detailed 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.

Interventions

DRUGAB680

AB680 is a Cluster of Differentiation (CD)73 Inhibitor

OTHERPlacebo

Matching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
AB680 Peak Plasma Concentration (Cmax)	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.
AB680 Time of Peak Concentration (Tmax)	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

Measure	Time frame	Description
Pharmacodynamic (PD) Effects of AB680	From First Dose Date to 15 Days After the Last Dose of AB680.	Enzymatic Activity of CD73 Measured in Participant Blood Samples.
Plasma Levels of Adenosine	From First Dose Date to 15 Days After the Last Dose of AB680.	Amount of Adenosine Measured in Participant Blood Samples.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026