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/ct2/show/NCT04845321




Registration number
NCT04845321
Ethics application status
Date submitted
10/04/2021
Date registered
14/04/2021
Date last updated
21/06/2022

Titles & IDs
Public title
VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers
Scientific title
Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers
Secondary ID [1] 0 0
VNRX-9945-101
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
Treatment: Drugs - VNRX-9945
Treatment: Drugs - Placebo for VNRX-9945

Experimental: VNRX-9945 - Oral dosing

Placebo Comparator: Placebo - Oral dosing


Treatment: Drugs: VNRX-9945
Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)

Treatment: Drugs: Placebo for VNRX-9945
Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of subjects with adverse events
Timepoint [1] 0 0
Up to 8 days after last administration of study drug
Primary outcome [2] 0 0
Part 2: Number of subjects with adverse events
Timepoint [2] 0 0
Up to 8 days after last administration of study drug
Secondary outcome [1] 0 0
Part 1: AUC0-tau
Timepoint [1] 0 0
Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary outcome [2] 0 0
Part 1: Cmax
Timepoint [2] 0 0
Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary outcome [3] 0 0
Part 1: tmax
Timepoint [3] 0 0
Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary outcome [4] 0 0
Part 1: AUCinf
Timepoint [4] 0 0
Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary outcome [5] 0 0
Part 1: t1/2
Timepoint [5] 0 0
Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary outcome [6] 0 0
Part 2: AUC0-tau
Timepoint [6] 0 0
Day 1 and Following Last Dose on Day 14
Secondary outcome [7] 0 0
Part 2: Cmax
Timepoint [7] 0 0
Day 1 and Following Last Dose on Day 14
Secondary outcome [8] 0 0
Part 2: tmax
Timepoint [8] 0 0
Day 1 and Following Last Dose on Day 14
Secondary outcome [9] 0 0
Part 2: t1/2
Timepoint [9] 0 0
Following Last Dose on Day 14

Eligibility
Key inclusion criteria
1. Healthy adults 18-55 years

2. Males or non-pregnant, non-lactating females

3. Body mass index (BMI) between 18 and 32.0 kg/m2 and total body weight >50 kg (110 lbs)

4. Normal blood pressure

5. Normal lab tests
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine,
autoimmune, hematologic, neoplastic, or neurological disorder

2. History of severe allergic or anaphylactic reaction

3. Abnormal ECG or history of clinically significant abnormal rhythm disorder

4. Positive alcohol, drug, or tobacco use/test

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


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2021
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Venatorx Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a 2-part first-in-human dose-ranging study to evaluate the safety and
pharmacokinetics of escalating doses of VNRX-9945.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04845321
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04845321