First-in-Human Study of Orally Administered GS-441524 for COVID-19
NCT ID: NCT04859244
Last Updated: 2021-08-10
Study Results
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.
COMPLETED
PHASE1
1 participants
INTERVENTIONAL
2021-01-01
2021-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy Subjects
NCT06274853
CC-42344 Safety Study in Healthy Participants
NCT05202379
Study of Obeldesivir in Nonhospitalized Participants With COVID-19
NCT05715528
Intravenous Zotatifin in Adults With Mild or Moderate COVID-19
NCT04632381
First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.
NCT04535167
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1: GS-441524 (QD, 7 days)
750 mg GS-441524 administered QD for 7 days
GS-441524
750 mg administered as a solution
Part 2: GS-441524 (TID, 3 days)
750 mg GS-441524 administered TID for 3 days
GS-441524
750 mg administered as a solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GS-441524
750 mg administered as a solution
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Positive pregnancy test
* Abuse of alcohol or drugs
* Other clinically significant medical conditions or laboratory abnormalities
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Copycat Sciences LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Victoria Yan
Role: PRINCIPAL_INVESTIGATOR
Copycat Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Copycat Sciences Study Site
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Humeniuk R, Mathias A, Cao H, Osinusi A, Shen G, Chng E, Ling J, Vu A, German P. Safety, Tolerability, and Pharmacokinetics of Remdesivir, An Antiviral for Treatment of COVID-19, in Healthy Subjects. Clin Transl Sci. 2020 Sep;13(5):896-906. doi: 10.1111/cts.12840. Epub 2020 Aug 5.
Tempestilli M, Caputi P, Avataneo V, Notari S, Forini O, Scorzolini L, Marchioni L, Ascoli Bartoli T, Castilletti C, Lalle E, Capobianchi MR, Nicastri E, D'Avolio A, Ippolito G, Agrati C; COVID 19 INMI Study Group. Pharmacokinetics of remdesivir and GS-441524 in two critically ill patients who recovered from COVID-19. J Antimicrob Chemother. 2020 Oct 1;75(10):2977-2980. doi: 10.1093/jac/dkaa239.
Davis MR, Pham CU, Cies JJ. Remdesivir and GS-441524 plasma concentrations in patients with end-stage renal disease on haemodialysis. J Antimicrob Chemother. 2021 Feb 11;76(3):822-825. doi: 10.1093/jac/dkaa472. No abstract available.
Yan VC, Muller FL. Advantages of the Parent Nucleoside GS-441524 over Remdesivir for Covid-19 Treatment. ACS Med Chem Lett. 2020 Jun 23;11(7):1361-1366. doi: 10.1021/acsmedchemlett.0c00316. eCollection 2020 Jul 9.
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Individual Participant Data Set
Supplementary Table 1: Blood chemistry (CBC, CMP) results. Supplementary Table 2: Plasma concentrations of GS-441524 at indicated timepoints.
View DocumentRelated Links
Access external resources that provide additional context or updates about the study.
Preliminary results
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CC-2021-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.