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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04722627




Registration number
NCT04722627
Ethics application status
Date submitted
20/01/2021
Date registered
25/01/2021

Titles & IDs
Public title
Study of AT-752 in Healthy Subjects
Scientific title
A First-in Human, Randomized, Double-blind, Placebo Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects
Secondary ID [1] 0 0
AT-02A-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dengue 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AT-752
Treatment: Drugs - Placebo

Experimental: AT-752 250 mg single dose - AT-752 administered orally, 250 mg on Day 1

Placebo comparator: Placebo -single dose - Matching placebo administered orally on Day 1

Experimental: AT-752 500 mg single dose - AT-752 administered orally, 500 mg single doses on Day 1 and Day 7

Placebo comparator: Placebo- single dose - Matching placebo administered orally on Day 1 and Day 7

Experimental: AT-752 1000 mg single dose - AT-752 administered orally, 1000 mg single dose on Day 1

Placebo comparator: Placebo - single dose - Matching placebo administered orally on Day 1

Experimental: AT-752 1500 mg single dose - AT-752 administered orally, 1500 mg single dose on Day 1

Placebo comparator: Placebo: single dose - Matching placebo administered orally on Day 1

Experimental: AT-752 - 1000 mg QD multiple doses - AT-752 - administered orally, 1000 mg once daily (QD) for 7 days

Placebo comparator: Placebo - Administered once daily (QD) - Matching placebo administered orally once daily (QD) for 7 days

Experimental: AT-752 - 750 mg twice daily (BID) - AT-752 administered orally, 750 mg twice daily (BID) for 4 days plus one dose on Day 5.

Placebo comparator: Placebo - Administered twice daily (BID) - Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5.

Experimental: AT-752 - 750 mg three times daily (TID) - AT-752 administered orally, 750 mg three times daily (TID) for 4 days plus one dose on Day 5.

Placebo comparator: Placebo - Administered TID - Matching placebo administered orally (TID) for 4 days plus one dose on Day 5.


Treatment: Drugs: AT-752
Parallel Assignment

Treatment: Drugs: Placebo
Parallel Assignment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
Timepoint [1] 0 0
Day 6 for single dose or Day 12 for multiple dose
Primary outcome [2] 0 0
Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
Timepoint [2] 0 0
Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses
Primary outcome [3] 0 0
Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
Timepoint [3] 0 0
Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]
Primary outcome [4] 0 0
Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose
Timepoint [4] 0 0
Day 1 for subjects receiving a single fed dose]
Primary outcome [5] 0 0
Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose
Timepoint [5] 0 0
Day 1 for subjects receiving a single fed dose ]

Eligibility
Key inclusion criteria
1. Body mass index (BMI) of 18-29 kg/m2
2. Must agree to use protocol-specified methods of contraception
3. Negative pregnancy test
4. Willing to comply with the study requirements and to provide written informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnant or breastfeeding
2. Abuse of alcohol or drugs
3. Use of other investigational drugs within 30 days of dosing
4. Other clinically significant medical conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/11/2021
Sample size
Target
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Atea Study Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atea Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04722627