A phase I clinical study to evaluate effects of ZYD1 in healthy people

A randomized, double blind, placebo controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYD1, a selective GLP-1 agonist, following the subcutaneous administrations in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/04/001684

Enrollment

112

Registered

2011-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: ZYD1: 5 to 50 mg subcutaneously OD or BID depending upon the pharmacokinetic profile obtained in Plan I (Single dose study) Control Intervention1: Placebo: 5 to 50 mg subcutaneously OD

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18-45 years 2. Mentally, physically and legally eligible to give informed consent. 3. Male and female volunteers weighing between 50-75kg and 45-75kg respectively. 4. Ability to communicate effectively with the study personnel. 5. Willingness to adhere to the protocol requirements. 6. For gender effect study, only females with history of sterility or at least one year menopause or use of long acting non-hormonal contraceptive measures (e.g., Intra uterine device) will be recruited.

Exclusion criteria

Exclusion criteria: 1. Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYD1 formulation. 2. Presence or history of Pancreatitis at any time (Serum Amylase/Serum Lipase more than UNL) 3. Presence or history of Severe Gastrointestinal disease in the last six months. 4. Presence or history of Renal insufficiency at any time (serum creatinine >1.5mg/dL). 5. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal (UNL). 6. 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). 7. Abnormal BT, CT, PT and APTT tests on the day of check in. 8. History or presence of any medication in the last 14 days. 9. History or presence of significant alcoholism or drug abuse within the past one year. 10. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day). 11. Difficulty with donating blood. 12. Systolic blood pressure more than 140mmHg and less than 100mmHg and diastolic blood pressure more than 90mmHg and less than 60mmHg. 13. Pulse rate less than 60/minute and more than 100/minute. 14. Any clinically significant abnormal X-ray or laboratory findings during screening. 15. History or presence of any clinically significant ECG abnormalities during screening. 16. Major illness and/or Major surgery in last 3 months. 17. Volunteers who have participated in any drug research study other than the present trial within past 3 months. 18. Volunteers who have donated one unit (350ml) of blood in the past 3 months. 19. 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 one 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.

Design outcomes

Primary

Measure	Time frame
1. Safety and tolerability 2. Pharmacokinetics (PK) after single and multiple subcutaneous administrations in healthy adult male volunteers 3. Pharmacodynamic (PD) effect after single and multiple subcutaneous dose administrations in healthy adult male volunteers. 4. Gender effects: Pharmacokinetics, Pharmacodynamic effect and safety parameters in female volunteers at pre-selected single dose will be compared with the results of single dose study in male volunteers.Timepoint: 1. For single dose and gender effect study - The venous blood samples will be withdrawn at pre-dose (before dosing), 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, 24, 48, 72 and 120 hrs post dose 2. Multiple dose study - Day 01 - Pre-dose, 1, 2, 3, 4 and 8 hours following first dosing. Day 02 to 06 - Pre-dose of each . Day 07 - Pre-dose, 1, 2, 3, 4 , 8, 12, 24, 36, 48, 72 and 120 hrs post dose	—

Measure

Time frame

1. Safety and tolerability 2. Pharmacokinetics (PK) after single and multiple subcutaneous administrations in healthy adult male volunteers 3. Pharmacodynamic (PD) effect after single and multiple subcutaneous dose administrations in healthy adult male volunteers. 4. Gender effects: Pharmacokinetics, Pharmacodynamic effect and safety parameters in female volunteers at pre-selected single dose will be compared with the results of single dose study in male volunteers.Timepoint: 1. For single dose and gender effect study - The venous blood samples will be withdrawn at pre-dose (before dosing), 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, 24, 48, 72 and 120 hrs post dose 2. Multiple dose study - Day 01 - Pre-dose, 1, 2, 3, 4 and 8 hours following first dosing. Day 02 to 06 - Pre-dose of each . Day 07 - Pre-dose, 1, 2, 3, 4 , 8, 12, 24, 36, 48, 72 and 120 hrs post dose

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Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr. Rajendra H. Jani

Cadila Healthcare Limited

rhjani@zyduscadila.com912226186057

Outcome results