A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers

MDK-703-101 is a single ascending dose study, to determine the safety, tolerability, and PK/PD of MDK-703 in healthy adult subjects.

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medikine Clinical Site

Herston, Queensland, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs.

Exclusion criteria

Significant history or clinical manifestation of any metabolic, autoimmune, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder.

Treatment and study plan

MDK-703 or Placebo

Biological

Injection

Primary outcomes

Assessment of adverse events after single injection of MDK-703

Time frame: 8 weeks

Adverse events after single Injection

Sponsors and collaborators

Lead sponsor

Medikine, Inc.

Industry

Collaborators

Medikine Australia Pty Ltd.

Registry information

Official study title

A Phase 1, Randomized, Placebo-controlled, Single-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDK-703 in Healthy Adult Volunteers

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: May 9, 2022
Registry last updated: May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed