Study of AT-752 in Healthy Subjects

NCT04722627 | Completed Phase 1

• 1 other identifier: AT-02A-001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects

Conditions

Dengue

Outcome Measures

Primary Outcomes (5)

• Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events

  Day 6 for single dose or Day 12 for multiple dose

• Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses

  Maximum plasma concentration (Cmax)

  Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses

• Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses

  Area under the concentration-time curve (AUC)

  Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]

• Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose

  Maximum plasma concentration (Cmax)

  Day 1 for subjects receiving a single fed dose]

• Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose

  Area under the concentration-time curve (AUC)

  Day 1 for subjects receiving a single fed dose ]

Study Arms (14)

AT-752 250 mg single dose

EXPERIMENTAL

AT-752 administered orally, 250 mg on Day 1

Drug: AT-752

Placebo -single dose

PLACEBO COMPARATOR

Matching placebo administered orally on Day 1

Drug: Placebo

AT-752 500 mg single dose

EXPERIMENTAL

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

Drug: AT-752

Placebo- single dose

PLACEBO COMPARATOR

Matching placebo administered orally on Day 1 and Day 7

Drug: Placebo

AT-752 1000 mg single dose

EXPERIMENTAL

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

Drug: AT-752

Placebo - single dose

PLACEBO COMPARATOR

Matching placebo administered orally on Day 1

Drug: Placebo

AT-752 1500 mg single dose

EXPERIMENTAL

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

Drug: AT-752

Placebo: single dose

PLACEBO COMPARATOR

Matching placebo administered orally on Day 1

Drug: Placebo

AT-752 - 1000 mg QD multiple doses

EXPERIMENTAL

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

Drug: AT-752

Placebo - Administered once daily (QD)

PLACEBO COMPARATOR

Matching placebo administered orally once daily (QD) for 7 days

Drug: Placebo

AT-752 - 750 mg twice daily (BID)

EXPERIMENTAL

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

Drug: AT-752

Placebo - Administered twice daily (BID)

PLACEBO COMPARATOR

Matching placebo administered orally twice daily (BID) for 4 days plus one dose on Day 5.

Drug: Placebo

AT-752 - 750 mg three times daily (TID)

EXPERIMENTAL

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

Drug: AT-752

Placebo - Administered TID

PLACEBO COMPARATOR

Matching placebo administered orally (TID) for 4 days plus one dose on Day 5.

Drug: Placebo

Interventions

AT-752 DRUG

Parallel Assignment

AT-752 - 1000 mg QD multiple doses; AT-752 - 750 mg three times daily (TID); AT-752 - 750 mg twice daily (BID); AT-752 1000 mg single dose; AT-752 1500 mg single dose; AT-752 250 mg single dose; AT-752 500 mg single dose

Placebo DRUG

Parallel Assignment

Placebo - Administered TID; Placebo - Administered once daily (QD); Placebo - Administered twice daily (BID); Placebo - single dose; Placebo -single dose; Placebo- single dose; Placebo: single dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) of 18-29 kg/m2
• Must agree to use protocol-specified methods of contraception
• Negative pregnancy test
• Willing to comply with the study requirements and to provide written informed consent

You may not qualify if:

• Pregnant or breastfeeding
• Abuse of alcohol or drugs
• Use of other investigational drugs within 30 days of dosing
• Other clinically significant medical conditions

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead

Study Sites (1)

Atea Study Site

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• Zhou X-J, Lickliter J, Montrond M, Ishak L, Pietropaolo K, James D, Belanger B, Horga A, Hammond J. First-in-human trial evaluating safety and pharmacokinetics of AT-752, a novel nucleotide prodrug with pan-serotype activity against dengue virus. Antimicrob Agents Chemother. 2024 May 2;68(5):e0161523. doi: 10.1128/aac.01615-23. Epub 2024 Mar 25.

  PMID: 38526047 DERIVED

MeSH Terms

Conditions

Dengue

Interventions

AT-752

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: March 9, 2021
• Primary Completion: November 14, 2021
• Study Completion: November 14, 2021
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)