Replication Data for: Development of an oral regimen of unithiol for the treatment of snakebite envenoming: a phase 1 open-label dose-escalation safety trial and pharmacokinetic analysis in healthy Kenyan adults (doi:10.7910/DVN/SAJJMX)

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Document Description

Citation

Title:

Replication Data for: Development of an oral regimen of unithiol for the treatment of snakebite envenoming: a phase 1 open-label dose-escalation safety trial and pharmacokinetic analysis in healthy Kenyan adults

Identification Number:

doi:10.7910/DVN/SAJJMX

Distributor:

Harvard Dataverse

Date of Distribution:

2025-11-17

Version:

1

Bibliographic Citation:

Abouyannis, Michael; Nyambura, Yvonne K.; Ngome, Samson; Riako, Debra; Musyoki, Jennifer; Muiruri, Charles; Orindi, Benedict; Else, Laura; Amara, Alieu; Dickinson, Laura; Clare, Rachel H.; Albulescu, Laura-Oana; Westhorpe, Adam P.; Kool, Jeroen; Adetifa, Ifedayo; Ndungu, Francis; FitzGerald, Richard; Khoo, Saye; Lalloo, David G.; Casewell, Nicholas R.; Hamaluba, Mainga, 2025, "Replication Data for: Development of an oral regimen of unithiol for the treatment of snakebite envenoming: a phase 1 open-label dose-escalation safety trial and pharmacokinetic analysis in healthy Kenyan adults", https://doi.org/10.7910/DVN/SAJJMX, Harvard Dataverse, V1

Study Description

Citation

Title:

Replication Data for: Development of an oral regimen of unithiol for the treatment of snakebite envenoming: a phase 1 open-label dose-escalation safety trial and pharmacokinetic analysis in healthy Kenyan adults

Identification Number:

doi:10.7910/DVN/SAJJMX

Authoring Entity:

Abouyannis, Michael (Centre for Snakebite Research & Interventions, Liverpool School of Tropical Medicine, Liverpool, UK; KEMRI-Wellcome Research Programme, Kilifi, Kenya)

Nyambura, Yvonne K. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Ngome, Samson (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Riako, Debra (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Musyoki, Jennifer (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Muiruri, Charles (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Orindi, Benedict (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Else, Laura (Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK)

Amara, Alieu (Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK)

Dickinson, Laura (Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK)

Clare, Rachel H. (Centre for Snakebite Research & Interventions, Liverpool School of Tropical Medicine, Liverpool, UK)

Albulescu, Laura-Oana (Centre for Snakebite Research & Interventions, Liverpool School of Tropical Medicine, Liverpool, UK)

Westhorpe, Adam P. (Centre for Snakebite Research & Interventions, Liverpool School of Tropical Medicine, Liverpool, UK)

Kool, Jeroen (Division of BioAnalytical Chemistry, Amsterdam Institute of Molecular and Life Sciences (AIMMS), Vrije Universiteit Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, the Netherlands; Centre for Analytical Sciences Amsterdam (CASA), 1098 XH, Amsterdam, the Netherlands)

Adetifa, Ifedayo (KEMRI-Wellcome Research Programme, Kilifi, Kenya; Department of Infectious Diseases Epidemiology, London School of Hygiene & Tropical Medicine, London, UK)

Ndungu, Francis (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

FitzGerald, Richard (NIHR Royal Liverpool and Broadgreen CRF, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK)

Khoo, Saye (Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK; NIHR Royal Liverpool and Broadgreen CRF, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK)

Lalloo, David G. (Centre for Snakebite Research & Interventions, Liverpool School of Tropical Medicine, Liverpool, UK)

Casewell, Nicholas R. (Centre for Snakebite Research & Interventions, Liverpool School of Tropical Medicine, Liverpool, UK)

Hamaluba, Mainga (KEMRI-Wellcome Research Programme, Kilifi, Kenya; Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK)

Distributor:

Harvard Dataverse

Access Authority:

Abouyannis, Michael

Access Authority:

Data Governance Committee

Depositor:

Abouyannis, Michael

Date of Deposit:

2025-11-17

Holdings Information:

https://doi.org/10.7910/DVN/SAJJMX

Study Scope

Keywords:

Medicine, Health and Life Sciences

Topic Classification:

Phase 1 clinical trial, Snakebite, Envenoming, Unithiol

Abstract:

<p>This is a replication dataset for the manuscript titled: "Development of an oral regimen of unithiol for the treatment of snakebite envenoming: a phase 1 open-label dose-escalation safety trial and pharmacokinetic analysis in healthy Kenyan adults."</p>

Kind of Data:

Clinical Trial

Kind of Data:

Restricted Access

Methodology and Processing

Sources Statement

Data Access

Notes:

<a href="http://creativecommons.org/licenses/by/4.0">CC BY 4.0</a>

Other Study Description Materials

Other Study-Related Materials

Label:

Abouyannis_TRUE1_data _readme.txt

Notes:

text/plain

Other Study-Related Materials

Label:

Analyticalplan_BCA38_220117_v1.pdf

Notes:

application/pdf

Other Study-Related Materials

Label:

Case Report Form Templates.zip

Notes:

application/zip

Other Study-Related Materials

Label:

consort_dig.csv

Notes:

text/comma-separated-values

Other Study-Related Materials

Label:

ICFs.zip

Notes:

application/zip

Other Study-Related Materials

Label:

solic_ae.csv

Notes:

text/comma-separated-values

Other Study-Related Materials

Label:

TRUE-1_protocol_v2.pdf

Notes:

application/pdf

Other Study-Related Materials

Label:

unsolic_ae.csv

Notes:

text/comma-separated-values