COVID-19 InfectionPhase 1PHONICNCT06965751
A Study on the Effects in Healthy People of a New Drug Called PDI204 for Treating COVID-19
A Phase 1 study testing PDI204 and 0.9 % saline in people with COVID-19 Infection, run by University of Melbourne at 1 site in Australia.
Trial summary
The goal of this clinical trial is to learn if a new drug called PDI204, developed for treating or preventing COVID-19, is safe and well-tolerated in healthy volunteers. This is a first-in-human study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- PDI204 and 0.9 % saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Jun 2025to Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Male or female, ≥18 and ≤65 years of age, with BMI >18.5 and <32.0 kg/m2. 2. Healthy as defined by:
- The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
- 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:
- <!-- -->
- post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented FSH levels 40 mIU/mL or greater; or
Show all 12Show fewer
- 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
Who cannot join
- Any clinically significant abnormal finding at physical examination.
- 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.
- Positive pregnancy test or lactating female participant.
- Positive urine drug screen, or alcohol breath test.
- History of significant allergic reactions (e.g., anaphylactic reaction, hypersensitivity, angioedema) to any drug, in the opinion of investigator.
- 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.
Show all 26Show fewer
- 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.
- 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%).
- Participants who smoke more than 10 cigarettes per day or the equivalent per week.
- History of rare hereditary sucrose intolerance (e.g., genetic sucrose-isomaltase deficiency (GSID).
- 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).
- 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.
- Poor peripheral venous access for Cohorts 1a, 2a, and 3a.
- Fever (≥ 38.0°C) within 14 days before study drug administration.
- Positive Corona Virus Disease of 2019 (COVID-19) test at admission to the CRU.
- Vaccination (including COVID-19 vaccine) within 30 days prior to administration of PDI204.
- 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.
- 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.
- 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.
- Participants who have been infected by COVID-19, within 30 days prior to the drug administration.
- Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test.
- Previous infusion-related reaction, or severe adverse reaction following administration of a mAb.
- Use of medications within the timeframes specified in section 8.2.
- 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.
- 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.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The goal of this clinical trial is to learn if a new drug called PDI204, developed for treating or preventing COVID-19, is safe and well-tolerated in healthy volunteers. This is a first-in-human study. The main questions it aims to answer are:
Is PDI204 safe and well-tolerated in healthy people? How long for and how does the body interact with PDI204?
Read more
Researchers will compare side effects in people who receive PDI204 and in those who receive a placebo (a look-alike substance that contains no drug) to see if and how many side-effects there are with PDI204. Researchers will also measure how long PDI204 can be detected in the blood.
Participants will be asked to receive a single dose of PDI204. Participants will have to stay in the clinical center for the day of receiving the dose of PDI204 and will be discharged the next day. Participants will then need to come back to the clinical center for study visits on days 3, 5, 7 (+/-1), 15 (+/-1), 30 (+/-3), 60 (+/-3) and 90 (+/-7).
Read the detailed description
"A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD) of PDI204 as Intravenous Infusion or Intramuscular Injection in Healthy participants" will be a single center, Phase 1, randomized, double-blind, placebo controlled, sequential single ascending dose (SAD) study evaluating the safety, tolerability, and pharmacokinetics (PK) of PDI204 via a single intravenous (IV) or intramuscular (IM) dose in healthy adult participants. The study will also assess the incidence and impact of antidrug antibodies (ADAs) on PK parameters and evaluate SARS-CoV-2 neutralizing antibody (NAb) levels over time. The study will consist of a single part with 4 cohorts: 3 sequential cohorts receiving IV administration (Cohorts 1-3) in an ascending dose manner, and one cohort receiving IM administration (Cohort 4), which may partially or fully overlap with the first 3 cohorts. Each cohort will include 8 participants (6 participants receiving the active drug and 2 participants receiving the placebo), for a total of 32 participants. The study will include a screening visit from Day -28 to Day -2. Eligible participants will be admitted to the clinical site on Day 1 and will be discharged on Day 2 following the completion of all required assessments. Participants will return to the clinical site for follow-up visits on Days 3, 5, 7 (+/-1), 15 (+/-1), 30 (+/-3), 60 (+/-3) and 90 (+/-7). The total duration of study participation for each participant from screening through the study exit is anticipated to be approximately 118 days. A staggered dosing schedule will be used for dosing of each cohort and will include 2 sentinel participants (1 active and 1 placebo) dosed initially, and the remaining 6 participants dosed at least 24 hours later in Cohorts 1a, 2a and 3a (IV administration); and at least 48 hours later in Cohort 2b (IM administration). The planned dose range for IV administration (Cohorts 1-3) is anticipated to be from 200 to 1200 mg, while a single 300 mg dose is planned for IM administration (Cohort 4).Following completion of each dose level, a Safety Review Committee (SRC) will review the safety and tolerability data, as well as available PK data, in order to make decisions whether to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose. Additionally, the SRC may extend the duration of the IV infusion (Cohorts 1-3) if necessary to improve participant safety or tolerability.
- Conditions
- COVID-19 Infection
- Being tested
- PDI204, 0.9 % saline
- Keywords
- COVID-19, Phase 1, monoclonal antibody, healthy volunteers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDI204Drug
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
0.9 % salineOther
0.9% saline used as placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | PDI204 (anti SARS-CoV-2 spike proteinmonoclonal antibody) adminstered as a single intravenous or intramuscular dose Receives: Drug: PDI204 |
| Placebo | Placebo comparator | 0.9% saline administered as a single intravenous or intramuscular dose Receives: Other: 0.9 % saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of a single IV or IM dose of PDI204 in healthy adult participants
Adverse events (AEs), serious adverse events (SAEs), vital signs measurements (blood pressure, heart rate, respiratory rate, and body temperature), 12-lead electrocardiogram (ECG) recordings, physical examinations, injection site reactions, and clinical laboratory test results, including hematology, biochemistry, and urinalysis; in the active arm compared with the placebo arm
Measured: Cumulative by Day 90
Secondary outcomes (13)
Area under the serum concentration versus time curve to last observation (PDI204 pharmacokinetics: AUC0-t: time-averaged concentration )
In serum:
AUC0-t: Area under the concentration-time curve from time zero until the last observed concentration
Measured: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Area under the serum concentration versus time curve to infinity (PDI204 pharmacokinetics: time-averaged concentration to infinity, AUC0-inf)
In serum:
AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Residual area (PDI204 pharmacokinetics; % of time-averaged concentration due to extrapolation)
In serum:
Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as [1 - (AUC0-t/AUC0-inf)] x 100
Measured: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Peak serum concentration (PDI204 pharmacokinetics: Cmax )
In serum:
Cmax: Maximal observed concentration
Measured: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Time of peak serum concentration (PDI204 pharmacokinetics: Tmax)
In serum:
Tmax: Time when the maximal concentration is observed
Measured: Day 1 - 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Elimination half-life (PDI204 pharmacokinetics:T 1/2 el )
In serum:
T½ el: Terminal elimination half-life
Measured: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Elimination rate constant (PDI204 pharmacokinetics: K el )
In serum:
K el: Terminal elimination rate constant
Measured: Day 1 - predose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Clearance (PDI204 pharmacokinetics: Cl/F)
In serum:
Cl/F: Apparent clearance
Measured: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Volume of distribution (PDI204 pharmacokinetics: Vz/F)
In serum:
Vz/F: Apparent volume of distribution
Measured: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Incidence of anti-drug antibodies (ADAs)
Incidence of ADAs
Measured: Day 30
Serum PK parameters with and without ADAs
Comparison of serum PK parameters for participants with versus without ADAs.
Measured: Day 90
Changes in SARS-CoV-2 neutralising antibody (NAb) levels
Changes in SARS-CoV-2 NAb levels in serum and saliva from baseline
Measured: Days 30 and 90
Incidence of anti-drug antibodies (ADAs)
Incidence of ADAs
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start27 Jun 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Nucleus Network Ltd, Syneos Heath
- Responsible party
- Sponsor
- Investigators
- Stephen Kent, PhD, MD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965751
- Sponsor's protocol ID
- UoM-01-PDI204
- Acronym
- PHONIC
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 (skent@unimelb.edu.au). To gain access to the data, requestors will need to sign a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06965751
- Acronym / sponsor ID
- PHONIC / UoM-01-PDI204
- Conditions
- COVID-19 Infection
- Keywords
- COVID-19, Phase 1, monoclonal antibody, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Nucleus Network Ltd, Syneos Heath
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a new drug called PDI204, developed for treating or preventing COVID-19, is safe and well-tolerated in healthy volunteers. This is a first-in-human study. The main questions it aims to answer are:
Is PDI204 safe and well-tolerated in healthy people? How long for and how does the body interact with PDI204?
Researchers will compare side effects in people who receive PDI204 and in those who receive a placebo (a look-alike substance that contains no drug) to see if and how many side-effects there are with PDI204. Researchers will also measure how long PDI204 can be detected in the blood.
Participants will be asked to receive a single dose of PDI204. Participants will have to stay in the clinical center for the day of receiving the dose of PDI204 and will be discharged the next day. Participants will then need to come back to the clinical center for study visits on days 3, 5, 7 (+/-1), 15 (+/-1), 30 (+/-3), 60 (+/-3) and 90 (+/-7).
Detailed description
"A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD) of PDI204 as Intravenous Infusion or Intramuscular Injection in Healthy participants" will be a single center, Phase 1, randomized, double-blind, placebo controlled, sequential single ascending dose (SAD) study evaluating the safety, tolerability, and pharmacokinetics (PK) of PDI204 via a single intravenous (IV) or intramuscular (IM) dose in healthy adult participants. The study will also assess the incidence and impact of antidrug antibodies (ADAs) on PK parameters and evaluate SARS-CoV-2 neutralizing antibody (NAb) levels over time. The study will consist of a single part with 4 cohorts: 3 sequential cohorts receiving IV administration (Cohorts 1-3) in an ascending dose manner, and one cohort receiving IM administration (Cohort 4), which may partially or fully overlap with the first 3 cohorts. Each cohort will include 8 participants (6 participants receiving the active drug and 2 participants receiving the placebo), for a total of 32 participants. The study will include a screening visit from Day -28 to Day -2. Eligible participants will be admitted to the clinical site on Day 1 and will be discharged on Day 2 following the completion of all required assessments. Participants will return to the clinical site for follow-up visits on Days 3, 5, 7 (+/-1), 15 (+/-1), 30 (+/-3), 60 (+/-3) and 90 (+/-7). The total duration of study participation for each participant from screening through the study exit is anticipated to be approximately 118 days. A staggered dosing schedule will be used for dosing of each cohort and will include 2 sentinel participants (1 active and 1 placebo) dosed initially, and the remaining 6 participants dosed at least 24 hours later in Cohorts 1a, 2a and 3a (IV administration); and at least 48 hours later in Cohort 2b (IM administration). The planned dose range for IV administration (Cohorts 1-3) is anticipated to be from 200 to 1200 mg, while a single 300 mg dose is planned for IM administration (Cohort 4).Following completion of each dose level, a Safety Review Committee (SRC) will review the safety and tolerability data, as well as available PK data, in order to make decisions whether to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose. Additionally, the SRC may extend the duration of the IV infusion (Cohorts 1-3) if necessary to improve participant safety or tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: PDI204PDI204 (anti SARS-CoV-2 spike proteinmonoclonal antibody) adminstered as a single intravenous or intramuscular dose |
| Placebo | Placebo comparator | Other: 0.9 % saline0.9% saline administered as a single intravenous or intramuscular dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Male or female, ≥18 and ≤65 years of age, with BMI >18.5 and <32.0 kg/m2. 2. Healthy as defined by:
- <!-- -->
- 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.
Key exclusion criteria (26 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDI204PDI204 is a fully human, immunoglobulin G1 (IgG1) monoclonal antibody (mAb) directed against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein | Drug | Active |
| 0.9 % saline0.9% saline used as placebo | Other | Placebo |
Primary outcome
The safety and tolerability of a single IV or IM dose of PDI204 in healthy adult participants
Time frame: Cumulative by Day 90
Adverse events (AEs), serious adverse events (SAEs), vital signs measurements (blood pressure, heart rate, respiratory rate, and body temperature), 12-lead electrocardiogram (ECG) recordings, physical examinations, injection site reactions, and clinical laboratory test results, including hematology, biochemistry, and urinalysis; in the active arm compared with the placebo arm
13 secondary outcomes
Area under the serum concentration versus time curve to last observation (PDI204 pharmacokinetics: AUC0-t: time-averaged concentration )
Time frame: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Area under the serum concentration versus time curve to infinity (PDI204 pharmacokinetics: time-averaged concentration to infinity, AUC0-inf)
Time frame: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Residual area (PDI204 pharmacokinetics; % of time-averaged concentration due to extrapolation)
Time frame: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Peak serum concentration (PDI204 pharmacokinetics: Cmax )
Time frame: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Time of peak serum concentration (PDI204 pharmacokinetics: Tmax)
Time frame: Day 1 - 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Elimination half-life (PDI204 pharmacokinetics:T 1/2 el )
Time frame: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Elimination rate constant (PDI204 pharmacokinetics: K el )
Time frame: Day 1 - predose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Clearance (PDI204 pharmacokinetics: Cl/F)
Time frame: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Volume of distribution (PDI204 pharmacokinetics: Vz/F)
Time frame: Day 1 - pre-dose, 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90
Incidence of anti-drug antibodies (ADAs)
Time frame: Day 30
Serum PK parameters with and without ADAs
Time frame: Day 90
Changes in SARS-CoV-2 neutralising antibody (NAb) levels
Time frame: Days 30 and 90
Incidence of anti-drug antibodies (ADAs)
Time frame: Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. 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 (skent@unimelb.edu.au). To gain access to the data, requestors will need to sign a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Kent, PhD, MD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PDI204 and 0.9 % saline in people with COVID-19 Infection, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability of a single IV or IM dose of PDI204 in healthy adult participants (time frame: Cumulative by Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.