PA-001 Ph.1 Study in Healthy and Elderly Subjects

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.

Study Overview

• Status: Completed
• Conditions: COVID - 19
• Intervention / Treatment: Drug: PA-001

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75230
      • Fortrea Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD; Single-dose, sequential-group of PA-001	Drug: PA-001; PA-001 or Placebo was infused via IV in accordance with a randomized schedule, after a fast of at least 10 hours
Experimental: MAD; Multiple-dose, sequential-group of PA-001	Drug: PA-001; PA-001 or Placebo was infused via IV in accordance with a randomized schedule, after a fast of at least 10 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	For approx. 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	SAD only, predose to 48 hours after start of infusion

Collaborators and Investigators

• Sponsor: PeptiDream Inc.
• Collaborators: PeptiAID Inc.
• Investigators: Study Director: Masato Murakami, MD, PeptiAID Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Actual): June 2, 2025
• Study Completion (Actual): June 2, 2025

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: COVID-19; Peptide; coronavirus; SARS-CoV-2 spike protein; S2 region of the SARS-CoV-2 spike protein; Spike protein inhibitor
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronaviridae Infections; Nidovirales Infections; COVID-19; Coronavirus Infections
• Other Study ID Numbers: PA-001-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No