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NCT05366634 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05366634
Other study ID # MDK-703-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 30, 2022
Est. completion date December 28, 2022

Study information
Verified date February 2023
Source Medikine, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date December 28, 2022
Est. primary completion date December 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs. Exclusion Criteria: 1. Significant history or clinical manifestation of any metabolic, autoimmune, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• MDK-703 or Placebo
Injection

Locations
Country Name City State
Australia Medikine Clinical Site Herston Queensland

Sponsors (2)
Lead Sponsor Collaborator
Medikine, Inc. Medikine Australia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of adverse events after single injection of MDK-703 Adverse events after single Injection 8 weeks
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