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

Medikine

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: MDK-703 or Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05366634

MDK-703-101

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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26 participants in 3 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Biological: MDK-703 or Placebo

Cohort 2

Experimental group

Description:

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

Treatment:

Biological: MDK-703 or Placebo

Cohort 3

Experimental group

Description:

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

Treatment:

Biological: MDK-703 or Placebo