Study Reference No. - C1D05139
| Study Reference No. | Study Type | Compensation | Gender | Age | Demographic |
|---|---|---|---|---|---|
| C1D05139 | Healthy | $4000 | Males | 18 to 65 | Healthy, non-smokers for at least the past one year |
Study Details |
|
Study Purpose |
The purpose of this study is to compare and evaluate the safety and pharmacokinetics (processes by which drugs are absorbed, distributed in the body, localized in the tissues, and excreted) after administration of 150 mg/mL of the Reference Product (B) [ADL-018 Injection 150mg/mL solution in a single dose pre-filled syringe] with 150 mg/mL of the Test Product (A) [ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector], under fasting conditions. |
Study Duration |
Approximately 127 days from the day of check-in until end of study visit, 1 period with 48 hrs. post-dose confinement, 13 returns (approx. 1 to 1.5 hrs. for blood draw) |
Study Schedule |
|
General Screening |
30 Dec, 3, 6, 10, 13, 16 Jan 2025 |
Medical Screening |
Contact recruitment |
Study Visit(s) |
Contact recruitment. |
Follow-Up Visit(s) |
Contact recruitment. |
Other Notes |
|
Bring Valid Photo ID. |
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