A Sub-Chronic Evaluation of the Safety of Celastrol in Human Subjects

NCT05494112 | Unknown DMC

• 1 other identifier: AMT-002-2022
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety

Outcome Measures

Primary Outcomes (1)

• The effect of celastrol on the function of the liver

  Absence of Toxicity, as determined by comparison of periodic subject data to their baseline data

  90 days

Secondary Outcomes (42)

• EKG evaluation

  90 days

• Glucose (MG/DL)

  90 days

• BUN (MG/DL)

  90 days

• Creatine (MG/DL)

  90 days

• eGFR (ML/MIN/1.73)

  90 days

Study Arms (1)

Amount of Celastrol Administered

EXPERIMENTAL

Chronic evaluation of the same doses of Celastrol to each subject over 90-day period

Dietary Supplement: Celastrol

Interventions

Celastrol DIETARY_SUPPLEMENT

same dose of Celastrol will be given every day for a period of 90-days to all participants.

Also known as: 24,25,26-trinoroleana-1(10),3,5,7- tetraen-29-oic acid, 34157-83-0

Amount of Celastrol Administered

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Prisoners
• 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.

Sponsors & Collaborators

• Legend Labz, Inc.: lead

Study Sites (1)

Patient Plus Urgent Care

Baton Rouge, Louisiana, 70810, United States

RECRUITING

Related Publications (7)

• Kusy S, Ghosn EE, Herzenberg LA, Contag CH. Development of B cells and erythrocytes is specifically impaired by the drug celastrol in mice. PLoS One. 2012;7(4):e35733. doi: 10.1371/journal.pone.0035733. Epub 2012 Apr 24.

  PMID: 22545133 BACKGROUND

• Hou W, Liu B, Xu H. Celastrol: Progresses in structure-modifications, structure-activity relationships, pharmacology and toxicology. Eur J Med Chem. 2020 Mar 1;189:112081. doi: 10.1016/j.ejmech.2020.112081. Epub 2020 Jan 20.

  PMID: 31991334 BACKGROUND

• Sun H, Liu X, Xiong Q, Shikano S, Li M. Chronic inhibition of cardiac Kir2.1 and HERG potassium channels by celastrol with dual effects on both ion conductivity and protein trafficking. J Biol Chem. 2006 Mar 3;281(9):5877-84. doi: 10.1074/jbc.M600072200. Epub 2006 Jan 11.

  PMID: 16407206 BACKGROUND

• Sun M, Tang Y, Ding T, Liu M, Wang X. Inhibitory effects of celastrol on rat liver cytochrome P450 1A2, 2C11, 2D6, 2E1 and 3A2 activity. Fitoterapia. 2014 Jan;92:1-8. doi: 10.1016/j.fitote.2013.10.004. Epub 2013 Oct 19.

  PMID: 24144799 BACKGROUND

• Wang S, Liu K, Wang X, He Q, Chen X. Toxic effects of celastrol on embryonic development of zebrafish (Danio rerio). Drug Chem Toxicol. 2011 Jan;34(1):61-5. doi: 10.3109/01480545.2010.494664. Epub 2010 Oct 18.

  PMID: 20954803 BACKGROUND

• Yuan YY, Gu ZP, Shi QX, Qin GW, Xu RS, Cao L. [In vitro inhibition of celastrol on spermatozoa fertilization ability of guinea pig]. Yao Xue Xue Bao. 1995;30(5):331-5. Chinese.

  PMID: 7660802 BACKGROUND

• Zhang YS, Tu YY, Gao XC, Yuan J, Li G, Wang L, Deng JP, Wang Q, Ma RM. Strong inhibition of celastrol towards UDP-glucuronosyl transferase (UGT) 1A6 and 2B7 indicating potential risk of UGT-based herb-drug interaction. Molecules. 2012 Jun 5;17(6):6832-9. doi: 10.3390/molecules17066832.

  PMID: 22669039 BACKGROUND

MeSH Terms

Interventions

celastrol

Study Officials

• Rubin Patel, MD

  Patient Plus Urgent Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubin Patel, MD

CONTACT

225-224-8690; rubin@patientplusuc.com

Sarah Carabello, B.A.

CONTACT

225-716-2297; scabal4@lsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: healthy men and women volunteers, between 18 and 40 years of age, over a 90-day period.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 9, 2022
• Study Start: May 25, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: All data available on clinicaltrials.gov

Locations

US (1)