Amckaus PTY LTD.
Only SAD study will be conducted in this project. SAD represents single ascending dose. Multiple ascending dose have been cancelled. This decision has been made at the discretion of the Sponsor.
Healthy Volunteers
Adamgammadex Sodium
0.9% Sodium Chloride Injection
Phase 1
This study was designed to evaluate the safety and tolerability of Aom0319. The trial is designed as follows. 1. SAD: 32 participants will be studied in four groups with n = 8 (6 active: 2 placebo) per group.}}
Study Type : | Interventional |
Estimated Enrollment : | 32 participants |
Masking : | Quadruple |
Primary Purpose : | Treatment |
Official Title : | A Single-Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics Profile of Aom0319 in Healthy White Subjects |
Actual Study Start Date : | December 15, 2022 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | June 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: experimental group Four ascending dose levels of Aom0319 (n=24) for intravenous injection for once. Dosage day is Day 1. |
Drug: Adamgammadex Sodium |
Placebo Comparator: placebo group Four ascending dose levels of placebo (n=8) for intravenous injection for once. Dosage day is Day 1. |
Drug: 0.9% Sodium Chloride Injection |
Ages Eligible for Study: | 18 Years to 55 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Nucleus Network Pty Ltd
Melbourne, Australia,