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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05366634




Registration number
NCT05366634
Ethics application status
Date submitted
4/05/2022
Date registered
9/05/2022
Date last updated
8/05/2024

Titles & IDs
Public title
A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers
Scientific 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
Secondary ID [1] 0 0
MDK-703-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MDK-703 or Placebo

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

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

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


Other interventions: MDK-703 or Placebo
Injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of adverse events after single injection of MDK-703
Timepoint [1] 0 0
8 weeks

Eligibility
Key inclusion criteria
1. Medically healthy with no clinically significant medical history, physical examination,
laboratory profiles, vital signs, or ECGs.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/12/2022
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Medikine Clinical Site - Herston
Recruitment postcode(s) [1] 0 0
- Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medikine, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medikine Australia Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05366634
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries