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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06965751




Registration number
NCT06965751
Ethics application status
Date submitted
29/04/2025
Date registered
11/05/2025
Date last updated
8/07/2025

Titles & IDs
Public title
A Study on the Effects in Healthy People of a New Drug Called PDI204 for Treating COVID-19
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of PDI204 as Intravenous Infusion or Intramuscular Injection in Healthy Participants
Secondary ID [1] 0 0
UoM-01-PDI204
Universal Trial Number (UTN)
Trial acronym
PHONIC
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PDI204
Other interventions - 0.9 % saline

Experimental: Active - PDI204 (anti SARS-CoV-2 spike proteinmonoclonal antibody) adminstered as a single intravenous or intramuscular dose

Placebo comparator: Placebo - 0.9% saline administered as a single intravenous or intramuscular dose


Treatment: Drugs: PDI204
PDI204 is a fully human, immunoglobulin G1 (IgG1) monoclonal antibody (mAb) directed against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein

Other interventions: 0.9 % saline
0.9% saline used as placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The safety and tolerability of a single IV or IM dose of PDI204 in healthy adult participants
Timepoint [1] 0 0
Cumulative by Day 90
Secondary outcome [1] 0 0
Area under the serum concentration versus time curve to last observation (PDI204 pharmacokinetics: AUC0-t: time-averaged concentration )
Timepoint [1] 0 0
Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Secondary outcome [2] 0 0
Area under the serum concentration versus time curve to infinity (PDI204 pharmacokinetics: time-averaged concentration to infinity, AUC0-inf)
Timepoint [2] 0 0
Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Secondary outcome [3] 0 0
Residual area (PDI204 pharmacokinetics; % of time-averaged concentration due to extrapolation)
Timepoint [3] 0 0
Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Secondary outcome [4] 0 0
Peak serum concentration (PDI204 pharmacokinetics: Cmax )
Timepoint [4] 0 0
Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Secondary outcome [5] 0 0
Time of peak serum concentration (PDI204 pharmacokinetics: Tmax)
Timepoint [5] 0 0
Day 1 - 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Secondary outcome [6] 0 0
Elimination half-life (PDI204 pharmacokinetics:T 1/2 el )
Timepoint [6] 0 0
Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Secondary outcome [7] 0 0
Elimination rate constant (PDI204 pharmacokinetics: K el )
Timepoint [7] 0 0
Day 1 - predose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Secondary outcome [8] 0 0
Clearance (PDI204 pharmacokinetics: Cl/F)
Timepoint [8] 0 0
Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Secondary outcome [9] 0 0
Volume of distribution (PDI204 pharmacokinetics: Vz/F)
Timepoint [9] 0 0
Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Secondary outcome [10] 0 0
Incidence of anti-drug antibodies (ADAs)
Timepoint [10] 0 0
Day 30
Secondary outcome [11] 0 0
Serum PK parameters with and without ADAs
Timepoint [11] 0 0
Day 90
Secondary outcome [12] 0 0
Changes in SARS-CoV-2 neutralising antibody (NAb) levels
Timepoint [12] 0 0
Days 30 and 90
Secondary outcome [13] 0 0
Incidence of anti-drug antibodies (ADAs)
Timepoint [13] 0 0
Day 90

Eligibility
Key inclusion criteria
* 1. Male or female, =18 and =65 years of age, with BMI >18.5 and <32.0 kg/m2. 2. Healthy as defined by:

1. The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
2. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. Fully resolved basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) are acceptable.

3. Females of non-childbearing potential must be:

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1. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented FSH levels 40 mIU/mL or greater; or
2. surgically sterile (bilateral oophorectomy or hysterectomy) at least 3 months prior to dosing.

4. Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study as detailed in section 8.1.

5. Male participants must be willing not to donate sperm for 90 days and female participants must be willing not to donate eggs for 30 days after dosing.

6. Willing to abstain from alcohol, tobacco, and illicit drug use for 48 hours prior to admission to the CRU (Day -1) and during the inpatient period.

7. Non-tattooed, clear injection site (i.e., absence of dermatologic conditions, such as scarring or rash, that may impact the ability to assess injection site reactions) suitable for IV or IM injection and monitoring in the opinion of the Investigator.

8. Able to understand the study procedures and provide signed informed consent to participate in the study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any clinically significant abnormal finding at physical examination.
2. Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, or QuantiFERON®-TB test at screening. Per Investigator's discretion, a single repeat for safety laboratory assessment to confirm initial result and trending is allowed per investigator's discretion.
3. Positive pregnancy test or lactating female participant.
4. Positive urine drug screen, or alcohol breath test.
5. History of significant allergic reactions (e.g., anaphylactic reaction, hypersensitivity, angioedema) to any drug, in the opinion of investigator.
6. Clinically significant ECG abnormalities or vital signs abnormalities (systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 40 or over 90 mmHg, HR less than 40 or over 100 bpm, or RR less than 10 or over 22 bpm) at screening.
7. History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening. per investigator's discretion, a single repeat for drug abuse urine test in the event of a false positive is allowed.
8. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 14 units for women and 21 units for men of alcohol per week (1 unit = 200 mL of beer 5%, 83 mL of wine 12%, or 25 mL of distilled alcohol 40%).
9. Participants who smoke more than 10 cigarettes per day or the equivalent per week.
10. History of rare hereditary sucrose intolerance (e.g., genetic sucrose-isomaltase deficiency (GSID).
11. History of a known or suspected respiratory system disorder including, but not limited to, cystic fibrosis, interstitial lung disease, reactive airway disease, emphysema, chronic bronchitis, pulmonary hypertension, COPD, or asthma (participants with childhood asthma can be included in the study).
12. Diagnosis or suspected diagnosis of immunodeficiency or autoimmune diseases, or undergoing immunosuppressive therapy such as anticancer chemotherapy or radiotherapy before the study, or has received systemic corticosteroid treatment (topical corticosteroids are acceptable) within the past 120 days before dosing.
13. Poor peripheral venous access for Cohorts 1a, 2a, and 3a.
14. Fever (= 38.0°C) within 14 days before study drug administration.
15. Positive Corona Virus Disease of 2019 (COVID-19) test at admission to the CRU.
16. Vaccination (including COVID-19 vaccine) within 30 days prior to administration of PDI204.
17. Known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to human proteins, mAbs or antibody fragments, or to any components of the formulation of PDI204 and its excipients used in this study.
18. History of bleeding disorders or clotting disorders (e.g., hemophilia, thrombocytopenia) or those with a history of easy bruising or bleeding who may be at a higher risk for hematoma at the injection site.
19. Participants who had close contact (without PPE) as defined by the Centers for Disease Control and Prevention (CDC) in the past 14 days to someone diagnosed with SARS-CoV-2 infection or COVID-19 within 10 days of the close contact. Participants may be rescreened after 14 days provided that they remain asymptomatic.
20. Participants who have been infected by COVID-19, within 30 days prior to the drug administration.
21. Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test.
22. Previous infusion-related reaction, or severe adverse reaction following administration of a mAb.
23. Use of medications within the timeframes specified in section 8.2.
24. Participation in a clinical research study involving the administration of an investigational or marketed drug (including mAbs) or device within 30 days (or 5 half-lives since last receipt of an investigational drug, whichever is longer) prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
25. Donation of serum within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 30 days prior to screening.
26. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
4/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Nucleus Network Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Syneos Heath
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Stephen Kent, PhD, MD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stephen Kent, PhD, MD
Address 0 0
Country 0 0
Phone 0 0
+61 3 8344 9939
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie any published results, after deidentification (text, tables, figures, and appendices) will be shared. The Study Protocol and Informed Consent Form will also be made available. These data will be shared with Investigators whose proposed use of the data has been approved by an independent review committee, for the purpose of participant data meta-analysis. The data will be available 3 months after publication and ending 5 years following publication. Proposals should be directed to Professor Stephen Kent ([email protected]). To gain access to the data, requestors will need to sign a data sharing agreement.

Supporting document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
The data will be available 3 months after publication and ending 5 years following publication
Available to whom?
Investigators whose proposed use of the data has been approved by an independent review committee, for the purpose of participant data meta-analysis. Proposals should be directed to Professor Stephen Kent ([email protected]). To gain access to the data, requestors will need to sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06965751