A Study on the Effects in Healthy People of a New Drug Called PDI204 for Treating COVID-19

NCT06965751 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: UoM-01-PDI204
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

COVID-19 Infection

Keywords

COVID-19; Phase 1; monoclonal antibody; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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

  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 )

  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)

  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)

  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 )

  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)

  Day 1 - 30 minutes, 4 hours, 8 hours, 12 hours; Days 2, 3, 5, 7, 14, 30, 60 and 90

Study Arms (2)

Active

EXPERIMENTAL

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

Drug: PDI204

Placebo

PLACEBO COMPARATOR

0.9% saline administered as a single intravenous or intramuscular dose

Other: 0.9 % saline

Interventions

PDI204 DRUG

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

Active

0.9 % saline OTHER

0.9% saline used as placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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
• surgically sterile (bilateral oophorectomy or hysterectomy) at least 3 months prior to dosing.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. Able to understand the study procedures and provide signed informed consent to participate in the study

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Melbourne: lead
• Nucleus Network Ltd: collaborator
• Syneos Heath: collaborator

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Stephen Kent, PhD, MD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled Study

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 11, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available 3 months after publication and ending 5 years following publication
• Access Criteria: 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 (skent@unimelb.edu.au). To gain access to the data, requestors will need to sign a data sharing agreement.

Locations

AU (1)