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Trial registered on ANZCTR


Registration number
ACTRN12621000468820
Ethics application status
Approved
Date submitted
16/04/2021
Date registered
20/04/2021
Date last updated
23/03/2023
Date data sharing statement initially provided
20/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of of PRTX007 in Healthy Adults
Scientific title
A Phase 1, Randomised Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of PRTX007 in Normal Healthy Volunteers
Secondary ID [1] 303564 0
Protocol PRTX007-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 320928 0
Condition category
Condition code
Infection 318736 318736 0 0
Other infectious diseases
Respiratory 319351 319351 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 112 healthy men or women will be enrolled in this study. There will be two parts to the study.

In the first part of the study approximately 72 healthy men and women will be enrolled in up to 9 single ascending dose cohorts comprising 8 subjects each. Subjects within each cohort will be randomised to receive a single dose of either oral PRTX007 (6 subjects) or oral placebo (2 subjects). All cohorts will be started with sentinel dosing. All doses will be administered under direct observation in the Phase 1 unit. The doses for each cohort are shown below
Cohort 1: 50mg
Cohort 2: 100mg
Cohort 3: 150mg
Cohort 4: 200mg
Cohort 5: 300mg
Cohort 6: 400 mg
Cohort 7: 500 mg
Cohort 8: 600 mg
Cohort 13: 800mg

In the second part of the study approximately 40 healthy men and women will be enrolled into up to 4 multiple ascending dose cohorts comprising 10 subjects each. Subjects within each cohort will be randomised to receive multiple doses of either oral PRTX007 (8 subjects) or oral placebo (2 subjects). Each dose regimen will be administered every other day for 13 calendar days (7 total doses). All doses will be administered under direct observation in the Phase 1 unit. Final dose selection for the second part of the study will be based upon the data from the first part of the study. The currently proposed doses for each cohort are shown below
Cohort 9: 300mg every other day
Cohort 10: 400mg every other day
Cohort 11: 500mg every other day
Cohort 12: 750 mg every other day
Intervention code [1] 319854 0
Treatment: Drugs
Comparator / control treatment
Placebo control group. Placebo is a capsule filled with microcrystalline cellulose matched to the PRTX007 capsule
Control group
Placebo

Outcomes
Primary outcome [1] 326684 0
To evaluate the safety of single doses of PRTX007 when compared with placebo in healthy volunteers through the assessment of: treatment-emergent adverse events assessed through regular solicitation of volunteers and review of physical examination data, vital sign data including blood pressure measured using a digital blood pressure monitor, heart rate measured as beats per minute, temperature assessed using a digital thermometer and respiratory rate measured using a manual counting of breaths per minute, ECG data, and clinical laboratory assessments of blood and urine: hematology (standard panel), chemistry (standard panel) and urinalysis (standard panel)
Timepoint [1] 326684 0
Treatment-emergent adverse events will be collected from the time of signing the informed consent form through the final follow-up visit which is Day 28 for Cohorts 1, 3, 4, 5, 6, 7 and 8, and Day 56 for Cohort 2, Physical examinations in Cohorts 1, 3, 4, 5, 6, 7 and 8 will be conducted at screening, Day -1, Day 3, Day 5 and Day 28. Physical examinations in Cohort 2 will be conducted at screening, Day -1, Day 3, Day 5, Day 28, Day 31, Day 33 and Day 56. Clinical laboratory assessments of blood and urine in Cohorts 1, 3, 4, 5, 6, 7 and 8 will be collected at screening, Day -1, Day 2, Day 3, Day 5 and Day 28. Clinical laboratory assessments of blood and urine in Cohort 2 will be collected at screening, Day -1, Day 2, Day 3, Day 5, Day 28, Day 30, Day 31, Day 33 and Day 56. ECGs in Cohorts 1, 3, 4, 5, 6, 7 and 8 will be collected at screening, Day -1 and Day 1 at 30, 60, and 90 minutes, and 2, 3, 4, 6, 8, and 12 hours after dosing, Day 2 at 24 hours post dose, and at Day 28 ECGs in Cohort 2 will be collected at screening, on Day -1 and on Day 1 at 30, 60, and 90 minutes, and 2, 3, 4, 6, 8, and 12 hours after dosing, Day 2 at 24 hours post dose, Day 28, Day 29 at 30, 60, and 90 minutes, and 2, 3, 4, 6, 8, and 12 hours after dosing, Day 30 at 24 hours post dose, and at Day 56 Vital signs in Cohorts 1, 3, 4, 5, 6, 7 and 8 will be collected at screening, Day -1, Day 1 pre-dose and 1, 2, 4, 8, and hours post dose, Day 2, Day 3, Day 5 and Day 28. Vital signs in Cohort 2 will be collected at screening, Day -1, Day 1 pre-dose and 1, 2, 4, 8, and hours post dose, Day 2, Day 3, Day 5, Day 28, Day 29 pre-dose and 1, 2, 4, 8, and hours post dose, Day 30, Day 31, and Day 56
Primary outcome [2] 326685 0
To evaluate the safety of multiple doses of PRTX007 when compared with placebo in healthy volunteers through the assessment of: treatment-emergent adverse events assessed through regular solicitation of volunteers and review of physical examination data, vital sign data including blood pressure measured using a digital blood pressure monitor, heart rate measured as beats per minute, temperature and respiratory rate measured as breaths per minute, ECG data and clinical laboratory assessments of blood and urine: hematology (standard panel), chemistry (standard panel) and urinalysis (standard panel)
Timepoint [2] 326685 0
Treatment-emergent adverse events will be collected from the time of signing the informed consent form through the final follow-up visit which is on Day 42,
Physical examinations will be conducted at screening, on Day -1, Day 14, Day 21 and Day 42.
Clinical laboratory assessments of blood and urine will be collected at screening, on Day -1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 9, Day 11, Day 13, Day 14, Day 21 and Day 42.
ECGs will be collected at screening, and pre-dose and 2 hours post dose on Day 1, Day 3 , Day 5, Day 7, Day 9, Day 11 and Day 13 and on Day 42
Vital signs will be collected at screening, on Day -1, pre-dose and 1, 2, 3, 4 and 6 hours post dose on Day 1, Day 3 , Day 5, Day 7, Day 9, Day 11 and Day 13 and on Day 14, Day 21 and Day 42
Secondary outcome [1] 392352 0
This outcome is a composite outcome of the plasma concentrations of PRTX007 and its key metabolite PRX034 after a single oral dose of PRTX007
Timepoint [1] 392352 0
In Cohorts 1, 3, 4, 5, 6, 7 and 8 plasma samples will be collected pre-dose and then at 30, 60, and 90 minutes, and 2, 3, 4, 6, 8, and 12 hours post dose. A 24 hour post dosing sample will be collected on Day 2. In Cohort 2 plasma samples will be collected pre-dose and then at 30, 60, and 90 minutes, and 2, 3, 4, 6, 8, and 12 hours post dose. A 24 hour post dosing sample will be collected on Day 2. On Day 29 plasma samples will be collected pre-dose and then at 30, 60, and 90 minutes, and 2, 3, 4, 6, 8, and 12 hours after dosing. A 24 hour post dosing sample will be collected on Day 30.
Secondary outcome [2] 392362 0
This outcome is a composite outcome of the plasma concentrations of PRTX007 and its key metabolite PRX034 after multiple oral doses of PRTX007
Timepoint [2] 392362 0
On Day 1, samples will be collected pre-dose and then at 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, and 12 hours after dosing. A 24-hour post dosing sample will be collected on Day 2. On Day 3 and Day 5 samples will be collected pre-dose and at 2 and 6 hours post dose. On Day 13, samples will be collected pre-dose and then at 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, and 12 hours after dosing. A 24-hour post dosing sample will be collected on Day 14.
Secondary outcome [3] 392363 0
The PD effects of a single dose of PRTX007 will be assessed through measurement of cytokines and chemokines in blood. The panel will include panel polysubtype IFN alphas, CXCL10 (IP-10), IL-6, IL-10, IL-12p40, IL1-Ra, and TNFa
Timepoint [3] 392363 0
Samples will be collected on Day 1 pre-dose and then at 2, 6, and 12 hours after dosing. A 24 hour post dose sample will be collected on Day 2.
Secondary outcome [4] 392364 0
The PD effects of a single dose of PRTX007 will be assessed through measurement of mRNA and neopterin in blood.
Timepoint [4] 392364 0
Samples will be collected on Day 1 pre-dose and then at 2, 6, and 12 hours after dosing. A 24 hour post dose sample will be collected on Day 2.
Secondary outcome [5] 392365 0
The PD effects of a single dose of PRTX007 will be assessed through cellular assays of select immune cells in the blood. This includes plasmacytoid dendritic cells, natural killer cells, CD4+ and CD8+ t-cells
Timepoint [5] 392365 0
Samples will be collected on Day 1 pre-dose and then at 6 hours after dosing
Secondary outcome [6] 392366 0
The PD effects of multiple doses of PRTX007 will be assessed through measurement of cytokines and chemokines in blood. The panel will include panel polysubtype IFN alphas, CXCL10 (IP-10), IL-6, IL-10, IL-12p40, IL1-Ra, and TNFa
Timepoint [6] 392366 0
Samples will be collected on Day 1, Day 3, Day 5 and Day 13 pre-dose and then at 2, 6, and 12 hours after dosing. A 24 hour post dose sample will be collected on Day 2, 4, 6 and 14 respectively.
Secondary outcome [7] 392367 0
The PD effects of multiple doses of PRTX007 will be assessed through measurement of mRNA and neopterin in blood.
Timepoint [7] 392367 0
Samples will be collected on Day 1, Day 3, Day 5 and Day 13 pre-dose and then at 2, 6, and 12 hours after dosing. A 24 hour post dose sample will be collected on Day 2, 4, 6 and 14 respectively. On Day 7, Day 9 and Day 11 samples will be collected pre-dose and then at 24 hours after dosing. The 24 hour post dose samples will be collected on Days 8, 10, and 12 respectively.
Secondary outcome [8] 392368 0
The PD effects of multiple doses of PRTX007 will be assessed through cellular assays of select immune cells in the blood. This includes plasmacytoid dendritic cells, natural killer cells, CD4+ and CD8+ t-cells
Timepoint [8] 392368 0
Samples will be collected on Day 1, Day 5 and Day 13 pre-dose and then at 6 hours after dosing.

Eligibility
Key inclusion criteria
a. Female participants must be of non-childbearing potential, or,
b. If of childbearing potential, be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days post- dose.
c. Male participants, if not surgically sterilized and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 90 days post-dose and agree not to donate sperm during this period.
3. Is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and/or before the first dose of study drug.
4. Weigh at least 45 kg at the time of screening
5. Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 at the time of screening
6. Negative SARS-CoV2 test per site standards
7. Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments
8. Willing to refrain from over-the-counter or prescription medications or herbal, nutritional or dietary supplements from 7 days before first dose through the end of study.
9. Willing to refrain from alcohol and caffeine from 48 hours before first dose through the last dose of study drug
10. Subjects who smoke no more than 2 cigarettes or equivalent per week can be included in the study but must be willing to abstain from smoking during the confinement period.
11. Willing and able to provide written informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years prior to screening
2.. History of cardiovascular, cerebrovascular, or peripheral vascular disease, including, but not limited to, unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, hypertension, hypotension, or tachycardia.
3. Has a clinically significant history or presence of electrocardiogram (ECG) findings as judged by the PI or designee at screening
4. Has clinically significant laboratory abnormalities
5. History of prescription drug abuse or illicit drug use within 6 months prior to screening
6. History of alcohol abuse within 5 years prior to screening
7. Positive alcohol breath test or urine test for drugs of abuse
8. Positive test results for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antigen, and anti-human immunodeficiency virus (HIV) type 1 antibody
9. Has received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) prior to dosing
10. Has donated blood or plasma within 30 days prior to screening, or had a loss of whole blood of more than 500 mL within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening
11. Has experienced symptoms of acute illness or chronic disease within 14 days prior to screening, or any disease or condition (medical or surgical) that, by the determination of the PI, might compromise interpretation of safety or PK data, or would place the subject at risk as a result of participation in the study
12. Is unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements
13. Other unspecified reasons that, in the opinion of the PI or Sponsor, make the subject unsuitable for enrollment.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated simple randomisation sequence
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
Safety
Statistical methods / analysis
This is an exploratory study and therefore it is not powered for inferential statistical analyses. It is anticipated that approximately 112 healthy male or female adult subjects will be enrolled. This sample size is commonly used in studies of this design to obtain sufficient information on the safety, tolerability and PK

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/06/2021
Actual
11/06/2021
Date of last participant enrolment
Anticipated
1/11/2021
Actual
24/06/2022
Date of last data collection
Anticipated
15/12/2021
Actual
10/07/2022
Sample size
Target
112
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18829 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 33280 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307987 0
Commercial sector/Industry
Name [1] 307987 0
Primmune Therapeutics Australia Pty Ltd
Country [1] 307987 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Primmune Therapeutics Australia Pty Ltd
Address
Suite 5.02, Level 5
139 Macquarie Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 308708 0
None
Name [1] 308708 0
Address [1] 308708 0
Country [1] 308708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307980 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 307980 0
Ethics committee country [1] 307980 0
Australia
Date submitted for ethics approval [1] 307980 0
23/04/2021
Approval date [1] 307980 0
11/05/2021
Ethics approval number [1] 307980 0

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

Contacts
Principal investigator
Name 109122 0
Dr Charlotte Lemech
Address 109122 0
Scientia Clinical Research Ltd.
Levels 5 and 6, Bright Building, Corner High and Avoca Sts., Randwick, NSW 2031
Country 109122 0
Australia
Phone 109122 0
+61 293 825 807
Fax 109122 0
Email 109122 0
[email protected]
Contact person for public queries
Name 109123 0
Puja Motwani
Address 109123 0
Scientia Clinical Research Ltd.
Levels 5 and 6, Bright Building, Corner High and Avoca Sts., Randwick, NSW 2031
Country 109123 0
Australia
Phone 109123 0
+61 293 825 800
Fax 109123 0
Email 109123 0
[email protected]
Contact person for scientific queries
Name 109124 0
Richard Daniels
Address 109124 0
Primmune Therapeutics, Inc. 2333 State St, Suite 203, Carlsbad, CA 92008, United States
Country 109124 0
United States of America
Phone 109124 0
+17603307295
Fax 109124 0
Email 109124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregate participant data will be available from this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.