COVID - 19Phase 1NCT07518771
PA-001 Ph.1 Study in Healthy and Elderly Subjects
A Phase 1 study testing PA-001 in people with COVID - 19, run by PeptiDream Inc. at 1 site in United States.
Trial summary
This was a double blind, randomized, placebo controlled, single and multiple IV dose study conducted in 2 parts, single ascending dose and multiple ascending doses parts. The principal aim of this study was to obtain safety and tolerability data when PA-001 is administered IV as single and multiple doses to healthy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID - 19
- What is being tested?
- PA-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to 2 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Groups of healthy subjects: Males or females, of any race, between 18 and 65 years of age, inclusive.
- Group(s) of elderly subjects: Males or females, of any race, > 65 years of age.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, or have stable, chronic, non life threatening medical conditions, determined by no clinically significant findings
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder that, in the opinion of the investigator (or designee), could impact subject safety or the objectives of the study.
- Have signs and symptoms of any other liver disease, except nonalcoholic fatty liver disease, or any of the following, as determined from clinical laboratory evaluations:
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
- Positive hepatitis panel or positive human immunodeficiency virus test.
- Positive SARS-CoV-2 test at screening or check in.
- Have signs which shows something was not right in the ECG or history of additional risk factors for torsades de pointes.
Show all 9Show fewer
- Administration of a COVID 19 vaccine in the past 30 days prior to dosing.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half lives of that drug prior to dosing, whichever is longer.
- Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc.
Dallas, Texas, 75230
About this study
Official title: PA-001 - A Phase 1, Double Blind, Randomized, Placebo Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics in Healthy and Elderly Subjects
This was a double blind, randomized, placebo controlled, single and multiple IV dose study conducted in 2 parts, single ascending dose and multiple ascending doses parts. The principal aim of this study was to obtain safety and tolerability data when PA-001 is administered IV as single and multiple doses to healthy subjects. This information, together with the PK data, will help establish the doses and dosing regimen suitable for future studies in patients. The study also investigated the effects of age on the PK of PA-001 prior to patient studies.
- Conditions
- COVID - 19
- Being tested
- PA-001
- Keywords
- COVID-19, SARS-CoV-2 spike protein, S2 region of the SARS-CoV-2 spike protein, Peptide, Spike protein inhibitor, coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA-001Drug
PA-001 or Placebo was infused via IV in accordance with a randomized schedule, after a fast of at least 10 hours
| Study group | Role | What they receive |
|---|---|---|
| SAD | Experimental | Single-dose, sequential-group of PA-001 Receives: Drug: PA-001 |
| MAD | Experimental | Multiple-dose, sequential-group of PA-001 Receives: Drug: PA-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events after single and multiple IV dosed of PA-001 in healthy subjects
An adverse event (AE) was any untoward medical occurrence in a subject, temporally associated with the use of study intervention. A serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect and resulted in an important medical events. TEAEs were defined as events that occurred after start of treatment.
Measured: For approx. 8 weeks
Incidence of laboratory abnormalities (hematology, clinical chemistry and urinalysis test)
Clinical hematology parameters included: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, mean cell hemoglobin (MCH), MCH concentration and mean cell volume.
Chemistry parameters included: blood urea nitrogen, creatinine, estimated glomerular filtration rate, glucose, calcium, sodium, potassium, chloride, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, bicarbonate, gamma-glutamyl transferase, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, B-type natriuretic peptide, highly sensitive troponin T and lactate dehydrogenase.
Urinalysis parameters included: potential of hydrogen (pH), glucose, protein, blood, ketones, nitrite, leukocyte esterase, bilirubin, color and appearance, specific gravity.
Measured: For approx. 8 weeks
12-lead electrocardiogram parameters
A 12-lead ECG was performed. Clinically meaningful findings in ECG assessments were based on the investigator's judgment
Measured: For approx. 8 weeks
Secondary outcomes (5)
AUCinf of PA-001 in plasma following single and multiple IV dose
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve
Measured: SAD: predose to 48 hours after start of infusion, MAD: predose to 48 hours after start of the last infusion
AUClast of PA-001 in plasma following single and multiple IV dose
AUClast was calculated as area under the concentration time curve from time 0 to the time of the last quantifiable concentration
Measured: SAD: predose to 48 hours after start of infusion, MAD: predose to 48 hours after start of the last infusion
Cmax of PA-001 in plasma following a single and multiple IV dose
Cmax was maximum observed concentration. Cmax was observed directly from data
Measured: SAD: predose to 48 hours after start of infusion, MAD: predose to 48 hours after start of the last infusion
T1/2 of PA-001 in plasma following single and multiple IV dose
T1/2 was terminal elimination half life
Measured: SAD: predose to 48 hours after start of infusion, MAD: predose to 48 hours after start of the last infusion
Percent Urinary Recovery of PA-001 following single IV dose
Percentage of the dose administered recovered over the time interval, 0 hour to the end of collection
Measured: SAD only, predose to 48 hours after start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start30 Jul 2024
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- PeptiDream Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PeptiAID Inc.
- Responsible party
- Sponsor
- Investigators
- Masato Murakami, MD, Study director, PeptiAID Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518771
- Sponsor's protocol ID
- PA-001-101
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PA-001 - A Phase 1, Double Blind, Randomized, Placebo Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics in Healthy and Elderly Subjects
- ClinicalTrials.gov ID
- NCT07518771
- Acronym / sponsor ID
- PA-001-101
- Conditions
- COVID - 19
- Keywords
- COVID-19, SARS-CoV-2 spike protein, S2 region of the SARS-CoV-2 spike protein, Peptide, Spike protein inhibitor, coronavirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- PeptiDream Inc.Industry (pharma, biotech, devices)
- Collaborators
- PeptiAID Inc.
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 9 Apr 2026 (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.
This was a double blind, randomized, placebo controlled, single and multiple IV dose study conducted in 2 parts, single ascending dose and multiple ascending doses parts. The principal aim of this study was to obtain safety and tolerability data when PA-001 is administered IV as single and multiple doses to healthy subjects. This information, together with the PK data, will help establish the doses and dosing regimen suitable for future studies in patients. The study also investigated the effects of age on the PK of PA-001 prior to patient studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAD | Experimental | Drug: PA-001Single-dose, sequential-group of PA-001 |
| MAD | Experimental | Drug: PA-001Multiple-dose, sequential-group of PA-001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Groups of healthy subjects: Males or females, of any race, between 18 and 65 years of age, inclusive.
- Group(s) of elderly subjects: Males or females, of any race, > 65 years of age.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, or have stable, chronic, non life threatening medical conditions, determined by no clinically significant findings
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
Key exclusion criteria (9 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder that, in the opinion of the investigator (or designee), could impact subject safety or the objectives of the study.
- Have signs and symptoms of any other liver disease, except nonalcoholic fatty liver disease, or any of the following, as determined from clinical laboratory evaluations:
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
- Positive hepatitis panel or positive human immunodeficiency virus test.
- Positive SARS-CoV-2 test at screening or check in.
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 |
|---|---|---|
| PA-001PA-001 or Placebo was infused via IV in accordance with a randomized schedule, after a fast of at least 10 hours | Drug | MAD, SAD |
Primary outcome
Incidence and severity of adverse events after single and multiple IV dosed of PA-001 in healthy subjects
Time frame: For approx. 8 weeks
An adverse event (AE) was any untoward medical occurrence in a subject, temporally associated with the use of study intervention. A serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect and resulted in an important medical events. TEAEs were defined as events that occurred after start of treatment.
Incidence of laboratory abnormalities (hematology, clinical chemistry and urinalysis test)
Time frame: For approx. 8 weeks
Clinical hematology parameters included: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, mean cell hemoglobin (MCH), MCH concentration and mean cell volume. Chemistry parameters included: blood urea nitrogen, creatinine, estimated glomerular filtration rate, glucose, calcium, sodium, potassium, chloride, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, bicarbonate, gamma-glutamyl transferase, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, B-type natriuretic peptide, highly sensitive troponin T and lactate dehydrogenase. Urinalysis parameters included: potential of hydrogen (pH), glucose, protein, blood, ketones, nitrite, leukocyte esterase, bilirubin, color and appearance, specific gravity.
12-lead electrocardiogram parameters
Time frame: For approx. 8 weeks
A 12-lead ECG was performed. Clinically meaningful findings in ECG assessments were based on the investigator's judgment
5 secondary outcomes
AUCinf of PA-001 in plasma following single and multiple IV dose
Time frame: SAD: predose to 48 hours after start of infusion, MAD: predose to 48 hours after start of the last infusion
AUClast of PA-001 in plasma following single and multiple IV dose
Time frame: SAD: predose to 48 hours after start of infusion, MAD: predose to 48 hours after start of the last infusion
Cmax of PA-001 in plasma following a single and multiple IV dose
Time frame: SAD: predose to 48 hours after start of infusion, MAD: predose to 48 hours after start of the last infusion
T1/2 of PA-001 in plasma following single and multiple IV dose
Time frame: SAD: predose to 48 hours after start of infusion, MAD: predose to 48 hours after start of the last infusion
Percent Urinary Recovery of PA-001 following single IV dose
Time frame: SAD only, predose to 48 hours after start of infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Masato Murakami, MD study director
PeptiAID Inc.
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 PA-001 in people with COVID - 19, run by PeptiDream Inc. at 1 site in United States.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 9 Apr 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of adverse events after single and multiple IV dosed of PA-001 in healthy subjects (time frame: For approx. 8 weeks). The study lists 3 primary outcomes in all. 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 9 Apr 2026.