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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02941159 |
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Date of registration:
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08/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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SF2000SD Clinical Trial in Zambia
SF2000SD |
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Scientific title:
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A Phase I Single Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Safety and Tolerability of SF2000SD in Healthy Male Volunteers |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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43 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02941159 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Zambia
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Contacts
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Name:
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Modest Mulenga, MD; PhD |
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Address:
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Telephone:
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+260-212-620737 |
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Email:
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mulengam@tdrc.org.zm |
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Affiliation:
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Name:
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Modest Mulenga, MD; PhD |
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Address:
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Telephone:
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+260-212-620737 |
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Email:
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mulengam@tdrc.org.zm |
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Affiliation:
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Name:
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Ray Handema, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tropical Diseases Research Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
To be eligible to participate in study, the participant should be;
1. Male aged 18 to 45 years.
2. Available in Ndola during the 10 weeks study duration.
3. Able to provide proof of residence.
4. Able to complete Consent Form
5. In good health as determined by the combination of medical history, physical
examination, and clinical judgment and laboratory results following TDRC normal
ranges. Urine dipstick for protein and blood should be negative or trace. If either is
=1+, complete urinalysis will be obtained (UA). If microscopic UA confirms hematuria
or proteinuria = 1+, the volunteer is ineligible.
6. Serologically negative for HIV, HBV and HCV infection.
Exclusion Criteria:
Anyone who meets ANY of the following exclusion criteria will NOT qualify for enrolment
into the study.
1. Female
2. A history related to TB
3. Any of the following chronic illnesses: diabetes, asthma, hypertension, skin
conditions.
4. On herbal medicine and/ or traditional medicines or immune boosting treatments
5. Received an investigational drug or herbal medicine not less than 2 months by the time
of administration of the study dose
6. excessive alcohol consumption/alcohol abuse
7. Smokes
8. HIV and/or HBV and/or HCV positive
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Good Health
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Intervention(s)
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Biological: Placebo
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Biological: SF2000SD
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Primary Outcome(s)
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Proportion of study participants with changes in laboratory liver and renal values after administration of test product. These will include ALT, AST, ALP, Total biluribin, Glucose, Urea and Creatinine
[Time Frame: 56 days]
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Proportion of study participants with changes in blood hematological values after administration of test product. This will involve Full Blood Count (FBC) including differential for white blood cells
[Time Frame: 56 days]
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Proportion of study participants with clinical adverse events such as diarrhea, vomiting, changes in vital signs etc. associated with the test product
[Time Frame: 56 days]
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Secondary ID(s)
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SF2000SDPh1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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