A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Safety of a Bovine Thymus Nuclear Extract
Evaluate the Safety of a Bovine Thymus Nuclear Extract
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Bisma Sharif, MD
- Phone Number: 12267068903
- Email: bsharif@nutrasource.ca
Study Contact Backup
- Name: Stephanie Recker
- Phone Number: 18775777722
- Email: srecker@nutrasource.ca
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33615
- Model Research Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female participants who are between 18 - 65 years of age (inclusive).
- In good general health (i.e., no uncontrolled diseases or conditions) as deemed by the investigator and are able to consume the study product.
- Have a body mass index (BMI) range of 18.5 - 29.9 kg/m2 (inclusive).
- Agree to follow the restrictions on concomitant treatments as listed.
- Agree to use acceptable contraceptive methods as listed.
- Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
- Agree to the dosage instructions including the oral consumption of 8 tablets twice daily.
Exclusion Criteria:
- Individuals who are lactating, pregnant or planning to become pregnant during the study, or demonstrates a positive pregnancy test at Visit 2.
- Have a known sensitivity, intolerability, or allergy (especially to bovine products) to any of the study products or their excipients.
- Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease ("uncontrolled" defined as being unmedicated, have an unstable use of medication within 3 months prior to screening, or have a stable use of medication for 3 months but still have uncontrolled conditions).
- Have a chronic inflammatory condition (e.g., rheumatoid arthritis, lupus, or multiple-sclerosis).
- Have a neurological disorder which may impact cognitive testing (e.g., traumatic brain injury, epilepsy, neurodegenerative diseases).
- Have received an organ transplant or other forms of allografts or xenografts.
- Participants with sleep disorders (e.g., insomnia, sleep apnea, restless legs syndrome, narcolepsy, or any other condition that significantly affects sleep quality and duration)
- Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
- Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
- Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.
- Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
- Reports a clinically significant illness during the 28 days before the first dose of study product.
- Major surgery in 3 months prior to screening or planned major surgery during the study.
- Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study.
- Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
- Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: TPG1
Thymus Nuclear Extract Dose 1
|
|
|
Active Comparator: TPG2
Thymus Nuclear Extract Dose 2
|
|
|
Active Comparator: TPG3
Thymus Nuclear Extract Dose 3
|
Thymus Nuclear Extract Dose 3 (3440 mg [8 tablets, 2x/day; total 16 tablets per day])
|
|
Placebo Comparator: PL
Placebo
|
Placebo (8 tablets, 2x/day; total 16 tablets per day)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Heart rate (bpm)
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Blood pressure (mmHg)
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Weight (kg)
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Body mass index (kg/m2)
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels.
Time Frame: 12 weeks
|
Whole blood hemoglobin (g/dL)
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Hematocrit (%)
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Red Blood Cell Count
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Red Cell Distribution Width
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Mean Corpuscular Volume
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Mean Corpuscular Hemoglobin
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Mean Corpuscular Hemoglobin Concentration
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
White Blood Cell Count and Differential
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Platelet Count
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Mean Platelet Volume
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Blood Urea Nitrogen
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Creatinine
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Estimated Glomerular Filtration rate
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Alkaline Phosphatase
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Bilirubin Total
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Aspartate Aminotransferase
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Alanine Aminotransferase
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Albumin
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Total Protein
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Globulin
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Fasting Glucose Serum
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Chloride
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Sodium
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Potassium
|
12 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 12 weeks
|
Reports of adverse events
|
12 weeks
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)
Time Frame: 12 weeks
|
PROMIS Disturbance - short Form 8b score
|
12 weeks
|
|
To assess the impact of Thymus Nuclear extract at 3 dosage levels on transcriptome
Time Frame: 25 weeks
|
Whole Blood Transcriptome Analysis
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)
Time Frame: 12 weeks
|
Patient Health Questionnaire (PHQ-9) score
|
12 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)
Time Frame: 12 weeks
|
Self-Administered Gerocognitive Examination (SAGE) score
|
12 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Adrenal hormones:dehydroepiandrosterone
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Estradiol
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Sex Hormone-Binding Globulin
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Spermidine
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Spermine
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Putrescine
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Histamine
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Serotonin
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Tryptamine
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Tyramine
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Cadaverine
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Ferritin
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Phosphorus
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Calcium
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Magnesium
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Vitamin D
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Vitamin B12
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Folate
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Homocysteine
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IgM
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IgA
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IgG
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Rheumatoid Factor
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Anti-Citrullinated Protein Antibodies
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Collagen
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Con-Citrullinated Fibronectin
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Vimentin
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated GFAP
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Myelin Basic Protein
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Neuron-Specific Enolase
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated S100 Calcium-Binding Protein B
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Intracellular Adhesion Molecule
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Brain-Derived Neurotrophic Factor
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Actin
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Zonulin
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Myosin Heavy Chain 7
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Myoglobin
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Troponin
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Triglycerides
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Total Cholesterol
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Low-Density Lipoprotein Cholesterol
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
High-Density Lipoprotein Cholesterol
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Apolipoprotein A
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Lipoprotein A
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Apolipoprotein B
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IL-1
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IL-1 receptor antagonist protein (IL-1RN)
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IL-6
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IL-8
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IL-13
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IL-18
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IFN-alpha
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
IFN-beta
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
TGF-beta
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
TNF
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Serum Amyloid A
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Serum Tau
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Neurofilament Light
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
S100B
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
C-Reactive Protein
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
GFAP levels
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Free and Total Triiodothyronine
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Free and Total Thyroxine
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Thyroid Stimulating Hormone
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Triiodothyronine Uptake Test
|
25 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 25 weeks
|
Gama-Glutamyl Transferase
|
25 weeks
|
|
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time Frame: 25 weeks
|
Uric Acid
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Total Cortisol
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
C- Peptide
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 25 weeks
|
Lactate dehydrogenase
|
25 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 12 weeks
|
Corticoid-Binding Globulin
|
12 weeks
|
|
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
Time Frame: 12 weeks
|
Free Cortisol Index
|
12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Bassem F. El-Khodor, PHD, Standard Process Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- S01-24-01-T0071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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