TRUE-1: Trial of Repurposed Unithiol for snakebite Envenoming Phase 1 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Kenyan Adults) (doi:10.7910/DVN/LJOYSO)

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Part 1: Document Description
Part 2: Study Description
Part 5: Other Study-Related Materials
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Document Description

Citation

Title:

TRUE-1: Trial of Repurposed Unithiol for snakebite Envenoming Phase 1 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Kenyan Adults)

Identification Number:

doi:10.7910/DVN/LJOYSO

Distributor:

Harvard Dataverse

Date of Distribution:

2022-03-03

Version:

3

Bibliographic Citation:

Abouyannis, Michael, 2022, "TRUE-1: Trial of Repurposed Unithiol for snakebite Envenoming Phase 1 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Kenyan Adults)", https://doi.org/10.7910/DVN/LJOYSO, Harvard Dataverse, V3

Study Description

Citation

Title:

TRUE-1: Trial of Repurposed Unithiol for snakebite Envenoming Phase 1 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Kenyan Adults)

Identification Number:

doi:10.7910/DVN/LJOYSO

Authoring Entity:

Abouyannis, Michael (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Distributor:

Harvard Dataverse

Access Authority:

Abouyannis, Michael

Depositor:

Abouyannis, Michael

Date of Deposit:

2022-03-03

Holdings Information:

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

Study Scope

Keywords:

Medicine, Health and Life Sciences, Medicine, Health and Life Sciences

Abstract:

<p>This package contains DMP, SAP and DSMB charter for the TRUE-1: Trial of Repurposed Unithiol for snakebite Envenoming Phase 1 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Kenyan Adults).</p>

Notes:

<p><strong>Data Access: </strong>Open</p> <p><strong>License: </strong><a href="https://creativecommons.org/licenses/by/4.0/legalcode">Creative Commons Attribution 4.0 International</a> <a href="https://creativecommons.org/licenses/by/4.0/legalcode"><img src="https://i.creativecommons.org/l/by/3.0/88x31.png"> </a></p>

Methodology and Processing

Sources Statement

Data Access

Citation Requirement:

<p>Publications based on this data collection should acknowledge this source by means of bibliographic citation.</p>

Notes:

<p>This data is licensed under the <a href="https://creativecommons.org/licenses/by/4.0/legalcode">Creative Commons Attribution 4.0 International</a> <a href="https://creativecommons.org/licenses/by/4.0/legalcode"><img src="https://i.creativecommons.org/l/by/3.0/88x31.png"> </a> </p>

Other Study Description Materials

Other Study-Related Materials

Label:

Data Management Plan TRUE1_15102021.pdf

Notes:

application/pdf

Other Study-Related Materials

Label:

DSMB charter TRUE1_14042021.pdf

Notes:

application/pdf

Other Study-Related Materials

Label:

SSP_Laboratory_Processing_TRUE-1_PK_PD_Samples_version2.pdf

Notes:

application/pdf

Other Study-Related Materials

Label:

Statistical analysis plan TRUE1_31032021.pdf

Notes:

application/pdf

Other Study-Related Materials

Label:

TRUE-1 PIL ICF v3_01012021.pdf

Notes:

application/pdf