Study of AT-752 in Healthy Subjects

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Dengue

Treatments: Drug: Placebo; Drug: AT-752

Study type: Interventional

Funder types: Industry

Identifiers

NCT04722627

AT-02A-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 65 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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65 participants in 14 patient groups, including a placebo group

AT-752 250 mg single dose

Experimental group

Description:

AT-752 administered orally, 250 mg on Day 1

Treatment:

Drug: AT-752

Placebo -single dose

Placebo Comparator group

Description:

Matching placebo administered orally on Day 1

Treatment:

Drug: Placebo

AT-752 500 mg single dose

Experimental group

Description:

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

Treatment:

Drug: AT-752

Placebo- single dose

Placebo Comparator group

Description:

Matching placebo administered orally on Day 1 and Day 7

Treatment:

Drug: Placebo

AT-752 1000 mg single dose

Experimental group

Description:

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

Treatment:

Drug: AT-752

Placebo - single dose

Placebo Comparator group

Description:

Matching placebo administered orally on Day 1

Treatment:

Drug: Placebo

AT-752 1500 mg single dose

Experimental group

Description:

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

Treatment:

Drug: AT-752

Placebo: single dose

Placebo Comparator group

Description:

Matching placebo administered orally on Day 1

Treatment:

Drug: Placebo

AT-752 - 1000 mg QD multiple doses

Experimental group

Description:

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

Treatment:

Drug: AT-752

Placebo - Administered once daily (QD)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

AT-752 - 750 mg twice daily (BID)

Experimental group

Description:

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

Treatment:

Drug: AT-752

Placebo - Administered twice daily (BID)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: AT-752

Placebo - Administered TID

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo