A Sub-Chronic Evaluation of the Safety of Celastrol in Human Subjects
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Legend Labz, Inc.
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- The effect of celastrol on the function of the liver
Study Overview
Brief Summary
This is an open label safety study that will not be blinded or placebo controlled.
Purpose is to evaluate the safety of Celastrol in healthy men and women volunteers, between 18 and 40 years of age, over a 90-day period.
Celastrol is different than Cholesterol. Cholesterol is a risk for heart disease. Celastrol is a natural occurring compound extracted from the root of Tripterygium wilfordii, a herb used in Chinese medicine.
Detailed Description
Pre-study Visit A pre-study visit will occur approximately one week before the scheduled beginning of the study. At this time all nutritional supplements must be stopped. During this visit, the subjects will sign an Informed Consent, will provide a medical history and list their concurrent medications. They will have a physical exam and then have a blood sample taken and receive an EKG. Women of child-bearing age will provide a urine sample to test for pregnancy. The subjects will then have their eligibility assessed based on the inclusion/exclusion criteria.
Study Visit 1, Day 0 The subjects who meet the entrance criteria will arrive at the clinic at an appointed time, and will again have their concurrent medications reviewed. They will be assigned a unique study number and be given a vial of experimental product that contains the same number as the subject, and contains ten capsules of product. Each capsule will contain ~67 mg of Celastrol. Instructions on how and when to take the experimental product will be given to the subjects by the clinician. A log book or an electronic portal will be presented to each subject so that daily information, such as the day and time of product ingestion, and any self-perceived adverse events, will be recorded. Any self-perceived adverse events experienced prior to taking any product should be told to the clinician at this time.
The subjects will be instructed to bring their drug vials to every clinic visit so that compliance can be determined. Any subject who has less than an 80% compliance rate will be excused from the study.
Study Visit 2, Day 2 To test for any acute effects of the experimental product, the subjects will return to the clinic on day 2 of the study. A blood sample will be taken, the log-book and vial will be reviewed for compliance, concurrent medications and any self-perceived adverse events will be discussed. Their vials that were given on Study Day 1 will contain enough remaining experimental product capsules to support the study to Day 7. Three extra capsules will be provided in the event that the subject cannot return to the clinic on the exact day indicated.
Study Visit 3, Day 7 The subjects will return to the clinic on Day 7, and a blood sample will be taken. As before, the log-book and vial will be reviewed for compliance, and concurrent medications and any self-perceived adverse events will be discussed. A vial containing enough experimental product, plus three additional capsules, to last another 7 days will be given.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Individuals who are between 18 and 40 years of age and who are found to be healthy without any underlying medical conditions and are not taking any daily medications. This does not exclude patients who take drugs prn.
- •Individuals who have not be involved in other clinical trials during the last 45 days. However, individuals that participated in the Celastrol-Sperm Health study can enter the trial after a seven day "wash-out" period
- •Women of child-bearing age and ability who agree to abstain from sexual intercourse, or agree to use condoms or vaginal diaphragms or other devices designed to prevent pregnancy; or are taking hormonal medication designed to prevent pregnancy, during the entire course of the study.
- •Women with tubal ligations or other physical conditions that make it impossible to conceive.
- •Women who are not pregnant or breast-feeding.
Exclusion Criteria
- •Individuals who have been involved in any other clinical trial during the last 45 days.
- •Women of child-bearing age who do not agree to abstain from sexual intercourse, or do not agree to use condoms or vaginal diaphragms or other devices designed to prevent pregnancy, or who are not on hormonal medication designed to prevent pregnancy, during the entire course of the study.
- •Women who are pregnant or breast-feeding
- •Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
- •Individuals on medications that the clinician feels may interfere with the results
- •Medications that might interfere with blood chemistry, CBCs, or vital signs.
- •Subjects who are taking daily medications. The use of therapies prn, such as headache and allergy medication are allowed.
- •Subjects Less than 18 years of age
- •Subjects who have taken anabolic steroid use during the last six months.
- •Subjects with a current history of addictive alcohol or illegal drug abuse (e.g. cocaine, heroin, etc.). The use of marijuana is allowed.
Outcomes
Primary Outcomes
The effect of celastrol on the function of the liver
Time Frame: 90 days
Absence of Toxicity, as determined by comparison of periodic subject data to their baseline data
Secondary Outcomes
- Neutrophils (%)(90 days)
- BUN (MG/DL)(90 days)
- EKG evaluation(90 days)
- eGFR (ML/MIN/1.73)(90 days)
- CALC BUN/CREAT (Ratio)(90 days)
- Sodium (MEQ/L)(90 days)
- CALC A/G (Ratio)(90 days)
- ALT (U/L)(90 days)
- RBC (M/UL)(90 days)
- Eosinophils (%)(90 days)
- Glucose (MG/DL)(90 days)
- Carbon Dioxide (MEQ/L)(90 days)
- WBC (K/UL)(90 days)
- MCV (fL)(90 days)
- MCHC (G/DL)(90 days)
- Nucleated RBCS (/100 WBC'S)(90 days)
- Platelet Count (K/UL)(90 days)
- Creatine (MG/DL)(90 days)
- Chloride (MEQ/L)(90 days)
- Calcium (MG/DL)(90 days)
- CALC Globulin (G/DL)(90 days)
- AST (U/L)(90 days)
- Hemoglobin (G/DL)(90 days)
- Potassium (MEQ/L)(90 days)
- Albumin (G/DL)(90 days)
- Bilirubin, Total (MG/DL)(90 days)
- Alkaline Phosphatase (U/L)(90 days)
- Hematocrit (%)(90 days)
- MCH (PG)(90 days)
- RDW (%)(90 days)
- Monocytes (%)(90 days)
- Immature Granulocytes (%)(90 days)
- Absolute Monocytes (K/UL)(90 days)
- Absolute Eosinophils (K/UL)(90 days)
- Absolute Basophils (K/UL)(90 days)
- Protein, Total (G/DL)(90 days)
- Basophils (%)(90 days)
- Lymphocytes (%)(90 days)
- Absolute Neutrophils (K/UL)(90 days)
- Absolute Nucleated RBCS (K/UL)(90 days)
- MPV (fL)(90 days)
- Absolute Immature Granulocytes (K/UL)(90 days)