A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers
NCT ID: NCT06004921
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2023-10-16
2024-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Cohort 1 - AB801 Dose A
Participants will receive a single dose of AB801 or placebo
AB801
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Cohort 2 - AB801 Dose B
Participants will receive a single dose of AB801 or placebo
AB801
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Cohort 3 - AB801 Dose C
Participants will receive a single dose of AB801 or placebo
AB801
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Cohort 4 - AB801 Dose D
Participants will receive a single dose of AB801 or placebo
AB801
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Interventions
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AB801
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences
Locations
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Quotient Sciences - Nottingham
Nottingham, , United Kingdom
Countries
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Other Identifiers
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ARC-26
Identifier Type: -
Identifier Source: org_study_id
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