A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, Following Subcutaneous Administration in Healthy Volunteers

Inclusion criteria

• Age: 18-45 years
• Mentally, physically, and legally eligible to give informed consent
• Male and female volunteers weighing between 50-75 kg and 45-75 kg respectively
• Ability to communicate effectively with the study personnel
• Willingness to adhere to the protocol requirements
• For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting nonhormonal contraceptive measures (e.g., intrauterine device) will be recruited.

Exclusion criteria

• Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYD1 formulation
• Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL))
• Presence or history of severe gastrointestinal disease in the last 6 months
• Presence or history of renal insufficiency at any time (serum creatinine above the upper limit of the reference range)
• Active liver disease and/or liver transaminases greater than 1.5 X UNL
• Subject with personal or family history of medullary thyroid cancer
• Subject with personal or family history of multiple endocrine neoplasia syndrome type 2
• Subject with serum calcitonin >50 ng/L
• History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement)
• Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT) tests on the day of check in
• History or presence of any medication in the last 14 days including any medication known to interact with the Cytochrome P (CYP) 450 system
• History or presence of significant alcoholism or drug abuse within the past 1 year
• History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)
• Difficulty with donating blood
• Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg
• Pulse rate less than 60/minute and more than 100/minute
• Any clinically significant abnormal X-ray or laboratory findings during screening
• History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening
• Major illness and/or major surgery in last 3 months
• Volunteers who have participated in any drug research study other than the present trial within past 3 months
• Volunteers who have donated one unit (350 ml) of blood in the past 3 months
• For gender effect study, female volunteers with following criteria will not be recruited:

• History of pregnancy or lactation in the past 3 months
• Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility device or history of less than 1 year of menopause
• Using hormonal contraceptives
• Using hormone replacement therapy
• Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial
• Positive urine pregnancy test on the day of check-in