MedDataX Logo

Study of AT-527 in Healthy Subjects (R07496998)

NCT ID: NCT04711187

Last Updated: 2022-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2021-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal

NCT05256732

Healthy Volunteer Study
COMPLETED PHASE1

Safety, Tolerability, and Pharmacokinetics Study of ATH-1020

NCT05169671

Healthy Volunteers
COMPLETED PHASE1

A Study to Assess Pharmacokinetics, Safety, and Tolerability of Atumelnant in Healthy Japanese and Caucasian Participants

NCT07221084

Healthy Volunteers
RECRUITING PHASE1

Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of Single and Multiple-Doses of ATF936 and AXT914 Administered Orally in Healthy Subjects.

NCT00417261

Healthy
COMPLETED PHASE1

Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AHT956 in Healthy Subjects

NCT00410228

Healthy
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer Study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AT-527 Formulation 1 Dose 1

Group Type EXPERIMENTAL

AT-527 Formulation 1

Intervention Type DRUG

AT-527 Formulation 1 (R07496998)

Placebo Comparator

Intervention Type OTHER

Placebo Comparator

AT-527 Formulation 2 Dose 1

Group Type EXPERIMENTAL

AT-527 Formulation 2

Intervention Type DRUG

AT-527 Formulation 2 (R07496998)

AT-527 Formulation 2 Dose 2

Group Type EXPERIMENTAL

Placebo Comparator

Intervention Type OTHER

Placebo Comparator

AT-527 Formulation 2

Intervention Type DRUG

AT-527 Formulation 2 (R07496998)

AT-527 Formulation 1 Dose 3

Group Type EXPERIMENTAL

AT-527 Formulation 1

Intervention Type DRUG

AT-527 Formulation 1 (R07496998)

Placebo Comparator

Intervention Type OTHER

Placebo Comparator

AT-527 Formulation 2 Dose 3

Group Type EXPERIMENTAL

Placebo Comparator

Intervention Type OTHER

Placebo Comparator

AT-527 Formulation 2

Intervention Type DRUG

AT-527 Formulation 2 (R07496998)

AT-527 Formulation 2 Dose 1 Fast/Fed

Group Type EXPERIMENTAL

AT-527 Formulation 2

Intervention Type DRUG

AT-527 Formulation 2 (R07496998)

AT-527 Formulation 2 Dose 3 Fast/Fed

Group Type EXPERIMENTAL

AT-527 Formulation 2

Intervention Type DRUG

AT-527 Formulation 2 (R07496998)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AT-527 Formulation 1

AT-527 Formulation 1 (R07496998)

Intervention Type DRUG

Placebo Comparator

Placebo Comparator

Intervention Type OTHER

AT-527 Formulation 2

AT-527 Formulation 2 (R07496998)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atea Study Site

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AT-03A-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose Levels
NCT01889160 COMPLETED PHASE1
Study to Investigate Multiple Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects
NCT01171105 COMPLETED PHASE1
AT-301 Nasal Spray in Healthy Adults
NCT04519788 COMPLETED PHASE1
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects
NCT02632526 COMPLETED PHASE1
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers
NCT00754715 COMPLETED PHASE1
A Study of ACE-2494 in Healthy Subjects
NCT03478319 COMPLETED PHASE1
Study to Investigate the Safety, Tolerability and Activity of AZD5069 When Given as a Single Dose to Healthy Male and/or Female Subjects
NCT00953888 COMPLETED PHASE1
Study to Evaluate HT-4253 in Healthy Subjects
NCT06537817 COMPLETED PHASE1
A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105
NCT06432647 COMPLETED PHASE1
Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers
NCT00861718 COMPLETED PHASE1
Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People
NCT01162889 TERMINATED PHASE1
A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers
NCT01209221 COMPLETED PHASE1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Participants
NCT02398591 COMPLETED PHASE1
Safety, Tolerability and Pharmacokinetics of AM1476 in Healthy Subjects
NCT04691115 COMPLETED PHASE1
A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers
NCT01051505 COMPLETED PHASE1
A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults
NCT03597217 COMPLETED PHASE1
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143
NCT02521389 COMPLETED PHASE1
To Investigate the Safety and Tolerability of TC-5214 Following Oral Administration of Multiple Doses for up to 8 Days
NCT01145768 COMPLETED PHASE1
A Phase 1, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of ETH47 in Healthy Participants
NCT07055321 COMPLETED PHASE1
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers
NCT01864226 COMPLETED PHASE1
A Trial of SHR8735 in Healthy Subjects
NCT04701216 COMPLETED PHASE1
Safety of AEB071 in Healthy Volunteers and to Compare the Ethnicity, Metabolic, and Safety Effects Between Caucasian and Japanese Healthy Subjects
NCT00416546 COMPLETED PHASE1
Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers
NCT01037725 COMPLETED PHASE1
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants
NCT07271693 RECRUITING PHASE1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Participants
NCT01964872 COMPLETED PHASE1