A Study to Evaluate Safety, Tolerability and pK of Semaglutide ER Injectable Suspension in Healthy, Adult Human Subjects

Inclusion Criteria:

1. He/She should provide written informed consent.

2. He/She must be a healthy adult human male or non-pregnant, non-lactating females,18

• 45 years of age (both years inclusive).

3. He/She should have a body mass index ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 with body weightat least 55 kg for men and at least 48 kg for women.

4. He/She should have a baseline systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 100 mm Hg. Similarly baselinediastolic blood pressure with upper limit less than 90 mm Hg and lower limit morethan or equal to 60 mmHg.

5. He/She should have pulse rate not less than 60 beats/min and not more than 100beats/min and respiratory rate not less than 14 breaths/min and not more than 18breaths/min.

6. He/She must be of normal health as determined by medical history (includingmedication history) and physical examination performed within 21 days prior to thedosing.

7. He/She should have normal ECG, chest X-ray and vital signs.

8. He/She should have normal or clinically non-significant thyroid function tests (T3,T4 and TSH).

9. Availability of a study volunteer for the entire study duration and willingness toadhere to protocol requirements as evidenced by written informed consent.

10. If study volunteer is a female and is of child bearing potential practicing anacceptable method of birth control such as condoms, foams, jellies, diaphragm,intrauterine device (IUD), or abstinence for the duration of the study as judged bythe investigator(s), or If she is postmenopausal with spontaneous amenorrhea for atleast 01 year. or If she is surgically sterile (had a bilateral tubal ligation,bilateral oophorectomy with or without a hysterectomy and an absence of bleeding forat least 06 months).

Exclusion Criteria:

1. He/She is incapable of understanding the informed consent.

2. He/She has a history of hypersensitivity (e.g. anaphylactic reactions, angioedemaand serious skin reactions) or idiosyncratic reaction to active or inactiveingredient in the Semaglutide extended-release injectable suspension or any otherrelated drugs.

3. He/She has a history of impairment of renal, hepatic, cardiac, pulmonary orgastrointestinal function.

4. He/She has a history of tuberculosis, epilepsy, asthma, diabetes, psychosis and eyedisorders.

5. He/She has history of any pulmonary disorder (COPD, Asthma, Bronchitis, otherrespiratory disorders) and skin related disorders.

6. He/She has a personal or family history of Medullary Thyroid Carcinoma (MTC) or anyother thyroid tumors or Multiple Endocrine Neoplasia 2 (MEN 2) or any otherendocrine disorders.

7. He/She has a history of pancreatitis, diabetic retinopathy, gall bladder disease.

8. He/She has undergone surgery within the past 3 months prior to screening, or thoseplanning to undergo surgery during the trial period.

9. He/She has any difficulty in swallowing.

10. He/She regularly smokes more than 10 cigarettes daily or has difficulty inabstaining from tobacco for the entire study duration.

11. He/She has taken over the counter or prescribed medications, including vitamins,herbal supplements, insulin or drugs which promote insulin secretion, Sulfonylureas,any oral medications or any systemic medication within the past 30 days prior todosing.

12. He/She has a history of any psychiatric illness, which may impair the ability toprovide written, informed consent.

13. He/She has a history of alcohol or substance abuse within the last 05 years.

14. He/she using prohibited medications (e.g., sedative hypnotics, CNS depressants,including but not limited to opioid analgesics, benzodiazepines, sedatingantidepressants or antipsychotics, sedating antiepileptic drugs, generalanesthetics, muscle relaxants, and/or illicit CNS depressants).

15. He/She has clinically significant abnormal values of laboratory parameters.

16. He/She has participated in any other clinical investigation using experimental drugor had bled more than 350 mL in the past 90 days.

17. He/She is unable to or unlikely to be compliant with protocol requirements orrestrictions.

18. He/She, in whom study drug is contraindicated for medical reasons.

19. He/She is intolerant to venipuncture.

20. Positive results at screening for HIV, hepatitis B surface antigen (HBsAg),hepatitis C Virus (HCV) or syphilis.

21. Female volunteer who has used implanted or injected hormonal contraceptives anytimeduring the 06 months prior to study or used oral contraceptives within 14 daysbefore dosing.

22. Female volunteer who demonstrates a positive pregnancy test.

23. Female study volunteer who is pregnant, breast-feeding or who is likely to becomepregnant during the study.

24. Female using Hormonal IUD (Mirena), Norplant and other hormones, Depo-Provera, OCPs. (Females of child bearing age will be required to use 2 reliable forms ofcontraception such as condom and spermicidal or barrier method and spermicidal ifsexually active. However, the use of Copper IUD or Tubal ligation are sufficient).