A study to see the safety and tolerance of HARMB Capsules in Healthy adult human subjects.

Phase 1

Completed

• Registration Number: CTRI/2023/07/055881
• Lead Sponsor: Viridis BioPharma Pvt. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Healthy Male or Female subjects between 18 to 45 years of age (Both Inclusive).

2. Subjects with Normal physical examination at screening visit,

3. Subjects with Normal/ acceptable 12-lead electrocardiogram results at screening

4. Subjects with Laboratory results within normal range or clinically non-significant (CBC, total bilirubin, SGOT, SGPT,S. Creatinine, Lipid profile, Fasting Blood sugar, S. Uric acid

and urinalysis).

5. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

Exclusion Criteria

1. Subjects with any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic,

hematologic, hepatic, immunologic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major diagnosed disease or malignancy.

2. Subjects Having the Body Mass Index less than 18.5 kg/m2 and more than 30.0 kg/m2.

3. The subject has used any prescription medication within 7 days of dosing or over the-counter (OTC) medication within 48 h of

dosing or intends to use any prescription medication or OTC medication during the study period.

4. Known Allergy or hypersensitivity to any medication.

5. Subjects with history of HIV or hepatitis B or hepatitis C at screening visit.

6. History of drug and alcohol abuse.

7. Subjects who have addiction to smoking/tobacco/nicotine containing products.

8. Subjects suspected of having a high probability of noncompliance with the study procedure and/or completion of the study according to the investigator’s judgement.

9. Any past participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.

10. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the

course of study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Incidence of adverse events (AEs) after administration of Study drug. <br/ ><br>2.Changes in laboratory parameters from baseline to end of studyTimepoint: Day 16

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI