NCT05366634CompletedPhase 1
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Medikine, Inc.
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Assessment of adverse events after single injection of MDK-703
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Cohort 1
Experimental
Single injection of MDK-703 (dose level 1) or matching placebo
Intervention: MDK-703 or Placebo (Biological)
Cohort 2
Experimental
Single injection of MDK-703 (dose level 2) or matching placebo
Intervention: MDK-703 or Placebo (Biological)
Cohort 3
Experimental
Single injection of MDK-703 (dose level 3) or matching placebo
Intervention: MDK-703 or Placebo (Biological)
Outcomes
Primary Outcomes
Assessment of adverse events after single injection of MDK-703
Time Frame: 8 weeks
Adverse events after single Injection
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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