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Trial registered on ANZCTR
Registration number
ACTRN12624000967583
Ethics application status
Approved
Date submitted
1/07/2024
Date registered
8/08/2024
Date last updated
8/08/2024
Date data sharing statement initially provided
8/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A Phase 1, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 Following Randomized, Double-blind, Placebo-controlled Single Ascending Doses in Healthy Subjects
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Scientific title
A Phase 1, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 Following Randomized, Double-blind, Placebo-controlled Single Ascending Doses in Healthy Subjects
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Secondary ID [1]
312123
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PVT201_C1_001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary Biliary Cholangitis
333767
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Condition category
Condition code
Inflammatory and Immune System
330442
330442
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0
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Autoimmune diseases
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Oral and Gastrointestinal
330979
330979
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study involves evaluating 4 dose levels of PVT201 -
Cohort 1: 0.036 mg/kg; Cohort 2: 0.15 mg/kg; Cohort 3: 0.60 mg/kg; Cohort 4: 1.8 mg/kg
All participants will receive a single dose of PVT201 or placebo on Day 1 via intravenous infusion.
Adherence to the intervention will be done via supervised drug administration.
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Intervention code [1]
328560
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Treatment: Drugs
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Comparator / control treatment
Placebo-to-match. Placebo will be composed of 0.9% sodium chloride as the inactive ingredient.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To evaluate the safety and tolerability of a single dose of PVT201 in healthy participants. This outcome will be a composite outcome.
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Assessment method [1]
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Overall safety and tolerability will be assessed by adverse events (AEs), vital signs, clinical laboratory parameters, and ECG monitoring for any clinically significant findings. Adverse events will be monitored by clinical staff for any adverse reactions or events. Known adverse events from pre-clinical animal studies include but are not limited to: low food consumption, injection site irritation, diarrhoea, vomiting and excessive scratching. However, the study drug has not been previously administered to humans and so the adverse events are not known. Cardiovascular monitoring with vital signs and ECGs to ensure participant safety, along with clinical assessment for any AEs that are cardiovascular in nature. Liver/kidney function tests will also be monitored due to the possibility of iron level increases.
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Timepoint [1]
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Outcomes will be assessed upon clinic admission at Baseline (Day -1) and Day 1 (prior to dosing), for 24 hours post-dose until Day 2 upon discharge from the clinic, and again on Day 7 post-dose at the final study visit.
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Secondary outcome [1]
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To measure the pharmacokinetics (PK) of PVT201 in plasma following a single dose in healthy participants
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Assessment method [1]
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Plasma PK parameters including Concentration at time 0, AUCinf, AUC last, t1/2, Total apparent body clearance and apparent volume of distribution.
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Timepoint [1]
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Blood samples will be collected and measured on Day 1 (within 60 mins prior to dosing), 5, 10, 15, 20, 35, 45 mins, 1, 2, 4, 6, 8 and 12 hours post dose, 24 hours post-dose until Day 2 upon discharge from the clinic, and again on Day 7 post-dose at the final study visit.
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Eligibility
Key inclusion criteria
- Healthy male or female, 18 to 65 years of age, inclusive with BMI between 18.0 to 32.0 kg/m2, inclusive
- Carry the HLA DRB4*0101-allele
- Medically healthy without clinically significant abnormalities based on physical examination, vital signs, ECG, and clinical laboratory tests
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any hospitalisation or surgery within the past 4 weeks determined by an Investigator to be clinically relevant
- Any active infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications
- History of hypersensitivity reaction, anaphylaxis or other CS reactions or known allergy to the study drug or its ingredients including but not limited to dextran
- Participant has undergone splenectomy or thymectomy
- Use of an prescription medications within 14 days prior to the study drug administration or over-the-counter medications (excluding contraceptives), including herbal products and vitamins within 7 days prior to the study drug administration
- Blood donation within 3 weeks prior to dose administration
- Use of any vaccinations within 30 days prior to the study drug administration
- Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests
- History of drug or alcohol abuse
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomized to receive PVT201 or placebo according to the randomisation schedule and plan prepared prior to study start. Code-break tamper-evident envelopes containing treatment allocation per participant will be provided to the study site for emergency unblinding if required.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants who meet the study eligibility criteria will be assigned a randomisation number prior to dosing on Day 1, which corresponds to a study treatment (PVT201 or placebo). The allocation of PVT201 or placebo will be performed using a block randomization algorithm
and will be documented in the study randomization list generated by an unblinded statistician.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/09/2024
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Actual
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Date of last participant enrolment
Anticipated
10/12/2024
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Actual
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Date of last data collection
Anticipated
3/02/2025
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Parvus Therapeutics, Inc.
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Address [1]
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Parvus Therapeutics, Inc.
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Address
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Country
United States of America
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Secondary sponsor category [1]
318656
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Commercial sector/Industry
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Name [1]
318656
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Avance Clinical Pty Ltd
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Address [1]
318656
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Country [1]
318656
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315275
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Bellberry Human Research Ethics Committee A
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Ethics committee address [1]
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https://bellberry.com.au/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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13/05/2024
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Approval date [1]
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14/06/2024
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Ethics approval number [1]
315275
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Summary
Brief summary
The study Sponsor (Parvus Therapeutics) is developing a new drug called PVT201 for the treatment of Primary Biliary Cholangitis (PBC). This research study will examine the safety and tolerability of PVT201 for humans. This is a double-blind, randomized, placebo-controlled study where 4 dose levels of PVT201 will be evaluated in healthy volunteers. All participants will receive a single dose of PVT201 or Placebo on Day 1 of the study and participants will be followed-up on Day 2 & Day 7 of the study.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Thomas Polasek
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Address
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CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
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Country
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Australia
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Phone
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+61 458 162 715
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Thomas Polasek
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Address
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CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
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Country
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Australia
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Phone
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+61 458 162 715
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Thomas Polasek
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Address
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CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
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Country
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Australia
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Phone
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+61 458 162 715
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Fax
134200
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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