A Phase I Clinical Study to evaluate PK & PD of GeneSys Insulin Aspart

Phase 1

• Registration Number: CTRI/2022/11/047188
• Lead Sponsor: GeneSys Biologics Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Healthy human subjects between 18-45 years of age.

2. Subjects able to communicate effectively.

3. Normal range for OGTT.

4. Truly voluntarily participation.

5. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.

6. Body mass index in the range of 18.5 to 24.9 kg/m2 (weight should be >= 50 Kg).

7. Normal 12-lead ECG

8. Normal chest X-ray

9. Normal laboratory parameters

10. Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and VDRL

11. Subject willing to abstain from all kinds of alcoholic beverages, smoking, and caffeine/xanthine containing foods or beverages from 72.00 hours before admission till the last post-dose blood sample collection in each study period.

Exclusion Criteria

1. Subjects having history of contraindication or hypersensitivity (e.g., anaphylaxis) to Insulin

or related class of drugs will be excluded from the study.

2. A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

3. History or presence of diabetes, migraine, hypertension, cardiovascular, pulmonary, endocrine, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.

4. History or presence of gastrointestinal (GI) inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine.

5. History or presence of significant systemic diseases, seizures, psychiatric disorders, neurological disorders.

6. History of diabetic ketoacidosis

7. History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting)

8. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).

9. Any known enzyme inducing or inhibiting drug taken within 30 days before the study.

10. Participation in a drug research study within 90 days prior to dosing of this study.

11. Blood loss or whole blood donation within 90 days prior to drug administration.

12. Consumption of high caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day).

13. History of addiction to any recreational drug or drug dependence.

14. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g., fasting due to religious reasons.

15. History of dehydration from diarrhea, vomiting or any other reason within a period of 48.00 hours prior to study admission of each period.

16. Positive results for drugs of abuse (benzodiazepines, cocaines, opioids, amphetamines,

cannabinoids and barbiturates) in urine during the admission of each study period.

17. Positive results for alcohol consumption during the admission of each study period.

18. History of pre-existing bleeding disorder.

19. Difficulty with donating blood.

20. Difficulty in swallowing oral solids like tablets / capsules.

21. Blood pressure on the day of admission of each study period

a. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.

b. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.

22. Pulse rate less than 60 beats/minute or more than 100 beats/minute on the day of admission of each study period.

23. History of alcohol abuse and/or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary PK Parameters: <br/ ><br>INS-AUC0-t, INS-AUC0-inf, Cmax <br/ ><br> <br/ ><br>Primary PD Parameters: <br/ ><br>GIR-AUC0-12 and GIRmaxTimepoint: 0-12 hrs

Secondary Outcome Measures

Name	Time	Method
Secondary PK Parameters: <br/ ><br>Tmax , t1/2 and Kel <br/ ><br> <br/ ><br>Secondary PD Parameters: <br/ ><br>TGIRmaxTimepoint: 0-12 hrs