Trial Review

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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
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
Secondary ID [1] 312123 0
PVT201_C1_001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Biliary Cholangitis 333767 0
Condition category
Condition code
Inflammatory and Immune System 330442 330442 0 0
Autoimmune diseases
Oral and Gastrointestinal 330979 330979 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328560 0
Treatment: Drugs
Comparator / control treatment
Placebo-to-match. Placebo will be composed of 0.9% sodium chloride as the inactive ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 338202 0
To evaluate the safety and tolerability of a single dose of PVT201 in healthy participants. This outcome will be a composite outcome.
Timepoint [1] 338202 0
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.
Secondary outcome [1] 434955 0
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single dose in healthy participants
Timepoint [1] 434955 0
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.

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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)
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.
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.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
10/12/2024
Actual
Date of last data collection
Anticipated
3/02/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316481 0
Commercial sector/Industry
Name [1] 316481 0
Parvus Therapeutics, Inc.
Country [1] 316481 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Parvus Therapeutics, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 318656 0
Commercial sector/Industry
Name [1] 318656 0
Avance Clinical Pty Ltd
Address [1] 318656 0
Country [1] 318656 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315275 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 315275 0
https://bellberry.com.au/
Ethics committee country [1] 315275 0
Australia
Date submitted for ethics approval [1] 315275 0
13/05/2024
Approval date [1] 315275 0
14/06/2024
Ethics approval number [1] 315275 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134198 0
Dr Thomas Polasek
Address 134198 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 134198 0
Australia
Phone 134198 0
+61 458 162 715
Fax 134198 0
Email 134198 0
[email protected]
Contact person for public queries
Name 134199 0
Thomas Polasek
Address 134199 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 134199 0
Australia
Phone 134199 0
+61 458 162 715
Fax 134199 0
Email 134199 0
[email protected]
Contact person for scientific queries
Name 134200 0
Thomas Polasek
Address 134200 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 134200 0
Australia
Phone 134200 0
+61 458 162 715
Fax 134200 0
Email 134200 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


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.