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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04707131




Registration number
NCT04707131
Ethics application status
Date submitted
11/01/2021
Date registered
13/01/2021
Date last updated
16/02/2023

Titles & IDs
Public title
A Study of Single Ascending Dose of LEM-S401 in Healthy Participants
Scientific title
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate the Characteristics of the Safety, Tolerability and Pharmacokinetics of LEM-S401 in Healthy Adult Subjects
Secondary ID [1] 0 0
LEM-S401-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age Related Macular Degeneration 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Healthy male and female subjects aged 19 to = 65 years at screening
Minimum age
19 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Significant history or clinical manifestation of any hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, tumor, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, dermatological (eg, contact dermatitis, atopic dermatitis), or other
* History of drug abuse or positive urine drug screen at screening
* For all female subjects, pregnant (Urine-HCG positive) or breast-feeding subjects

Study design
Purpose of the study
Treatment
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
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
11/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/02/2023
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lemonex Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lemonex Inc. Study Director
Address 0 0
Lemonex Inc.
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04707131