First-in-Human Study of Orally Administered GS-441524 for COVID-19

Copycat Sciences

Status and phase: Completed; Phase 1

Conditions: COVID-19

Treatments: Drug: GS-441524

Study type: Interventional

Funder types: Industry

Identifiers

NCT04859244

CC-2021-001

Details and patient eligibility

About

This is a two-part study is to evaluate the multi-day safety, tolerability, and pharmacokinetics (PK) of orally administered GS-441524 in a healthy human volunteer.

Full description

Part 1: 750 mg GS-441524 administered once daily (QD) for 7 days. Part 2: 750 mg GS-441524 administered three times daily (TID) for 3 days.

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Willing and able to provide written informed consent
• 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

Exclusion criteria

• Use of other investigational drugs within 28 days of dosing
• Positive pregnancy test
• Abuse of alcohol or drugs
• Other clinically significant medical conditions or laboratory abnormalities

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Part 1: GS-441524 (QD, 7 days)

Experimental group

Description:

750 mg GS-441524 administered QD for 7 days

Treatment:

Drug: GS-441524

Part 2: GS-441524 (TID, 3 days)

Experimental group

Description:

750 mg GS-441524 administered TID for 3 days

Treatment:

Drug: GS-441524