A safety and tolerability study of Sodium Copper Chlorophyllin in healthy, adult human male subjects.

Phase 1

Recruiting

Conditions: ADULT, HUMAN MALE SUBJECTS

Registration Number: CTRI/2018/09/015576

Lead Sponsor: IDRS Labs Private Limited

Brief Summary: This study is being conducted to assess safety, tolerability, pharmacokinetics and pharmacodynamics of herbal molecule (Sodium Copper Chlorophyllin) in healthy adult, human male subjects. 15 Healthy Human Male subjects will be enrolled in the study. Subject will have to stay in the clinical facility for three consecutive nights in study period. In case of adverse events, necessary action will be taken until the event subsides. Three (3) cohorts of 5 healthy, adult human male volunteers between the ages of 18 and 45 years (both inclusive) will participate in this trial. A sufficient number of volunteers will be asked to report on the day of check-in of each cohort in order to ensure that at least 5 subjects will be enrolled in the beginning of the respective cohort. Subsequent dropouts after dosing in each cohort will not be replaced. Cohort 4 will be performed to evaluate the food effect on the same subjects from any one of the first 3 Cohorts based on the achieved maximum tolerated dose obtained from all 3 Cohorts. The data identifying each study subject by name will be kept confidential.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Male

Target Recruitment: 15

Inclusion Criteria

Non-smoker, Healthy, adult, human male volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
Having a Body Mass Index (BMI) between 18.5 to 24.9 (both inclusive), calculated as weight in kg/height in meter square.
Have no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings.
Able to understand and comply with the study procedures, in the opinion of the investigator.
Able to give voluntary informed consent for participation in the trial.

Exclusion Criteria

Known hypersensitivity or idiosyncratic reaction to Sodium Copper Chlorophyllin or to any of its excipients or any drug or any substance.
History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
Ingestion or Use of any medication [prescribed & over the counter (OTC) medication including herbal remedies] at any time within 14 days prior to dosing.
In any such case subject selection will be at the discretion of the Principal Investigator.
Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID (i.e. ibuprofen, aspirin) induced urticaria.
Consumption of grapefruits or grapefruits products within a period of 72 hours prior to dosing.
A recent history of harmful use of alcohol(less than 2 years) vii.
Smokers, or who have smoked within last six months prior to start of the study.
The presence of clinically significant abnormal laboratory values during screening.
Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
History or presence of psychiatric disorders.
A history of difficulty with donating blood.
Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication.
A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of Chlorophyllin.	During entire duration of the study

Secondary Outcome Measures

Name	Time	Method
The pharmacokinetics, modulation of pharmacodynamic markers and food effect of Chlorophyllin (CHL)	Day 1- Day 7

Trial Locations

Locations (1): Lambda Therapeutic Research Ltd
🇮🇳
Ahmadabad, GUJARAT, India
Lambda Therapeutic Research Ltd
🇮🇳Ahmadabad, GUJARAT, India
Dr Akash Patel
Principal investigator
07940202488
akashpatel@lambda-cro.com