Trial Review

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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
The primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects.
Trial website
https://clinicaltrials.gov/study/NCT04707131
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04707131