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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/NCT05019950




Registration number
NCT05019950
Ethics application status
Date submitted
16/08/2021
Date registered
25/08/2021
Date last updated
8/06/2023

Titles & IDs
Public title
Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers
Scientific title
A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers
Secondary ID [1] 0 0
LABP-104-1a
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NIM-1324
Treatment: Drugs - Placebo

Experimental: NIM-1324 - Once daily oral tablet

Placebo Comparator: Placebo - Once daily oral tablet


Treatment: Drugs: NIM-1324
Once daily oral tablet

Treatment: Drugs: Placebo
Once daily oral tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability
Timepoint [1] 0 0
1 to 14 days
Secondary outcome [1] 0 0
PK
Timepoint [1] 0 0
24 hours

Eligibility
Key inclusion criteria
Key

1. Must have given written informed consent before any study-related activities are
carried out and must be able to understand the full nature and purpose of the trial,
including possible risks and adverse effects;

2. Adult males and females, 18 to 64 years of age (inclusive) at screening;

3. Be willing and able to comply with all study assessments and adhere to the protocol
schedule and restrictions.

Key
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological
disease, including any acute illness or surgery within the past 3 months determined by
the PI to be clinically relevant;

2. Current infection that requires antibiotic, antifungal, antiparasitic or antiviral
medications;

3. COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20
days, or an asymptomatic infection within 6 weeks.

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
28/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/04/2022
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Clinical Site - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
NImmune Biopharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study.
The primary objective of this study is to assess the safety and tolerability of single and
7-day repeat oral doses NIM-1324 in healthy adult volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05019950
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