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

Medikine, Inc.26 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy Volunteers

Interventions

MDK-703 or PlaceboBIOLOGICAL

Injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Medikine Clinical Site

Herston, Queensland, Australia

Outcomes

Primary Outcomes

Assessment of adverse events after single injection of MDK-703

Adverse events after single Injection

Time frame: 8 weeks

Data from ClinicalTrials.gov

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