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Aom0319 SAD Study in Healthy Subjects

NCT05555758 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-11-27

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Adamgammadex Sodium

Aom0319 will be administered intravenously with water for injection.

DRUG

0.9% Sodium Chloride Injection

0.9% Sodium Chloride will be administered intravenously.

Sponsors & Collaborators

  • Amckaus PTY LTD.

    lead INDUSTRY

Principal Investigators

  • Kristi Mclendon, PhD · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2023-12-13
Completion
2023-12-21

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555758 on ClinicalTrials.gov