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NCT05366634 | Completed | Healthy Volunteers


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

Medikine, Inc.

Brief 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.

Condition or disease

Healthy Volunteers

Intervention/treatment

MDK-703 or Placebo

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 26 participants
Masking : Single
Primary Purpose : Basic Science
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
Actual Study Start Date : June 30, 2022
Estimated Primary Completion Date : December 28, 2022
Estimated Study Completion Date : December 28, 2022
Arm Intervention/treatment

Experimental: Cohort 1

Single injection of MDK-703 (dose level 1) or matching placebo

Biological: MDK-703 or Placebo

Experimental: Cohort 2

Single injection of MDK-703 (dose level 2) or matching placebo

Biological: MDK-703 or Placebo

Experimental: Cohort 3

Single injection of MDK-703 (dose level 3) or matching placebo

Biological: MDK-703 or Placebo

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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.

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

Location Details


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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Australia, Queensland

Medikine Clinical Site

Herston, Queensland, Australia,

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