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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: MDK-703 or Placebo

• Registration Number: NCT05366634
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Study Start: 2022-06-30
• Primary Completion: 2022-12-28
• Study Completion: 2022-12-28
• Status Verified: 2023-02
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	MDK-703 or Placebo	Single injection of MDK-703 (dose level 1) or matching placebo
Cohort 3	MDK-703 or Placebo	Single injection of MDK-703 (dose level 3) or matching placebo
Cohort 2	MDK-703 or Placebo	Single injection of MDK-703 (dose level 2) or matching placebo

Primary Outcome Measures

Name	Time	Method
Assessment of adverse events after single injection of MDK-703	8 weeks	Adverse events after single Injection

Trial Locations

Locations (1)

Medikine Clinical Site; 🇦🇺 Herston, Queensland, Australia