New COVID-19 drug candidate passes first safety check in healthy volunteers
NCT ID NCT07518771
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested the safety and tolerability of a new drug called PA-001 in 47 healthy and elderly volunteers. Participants received either PA-001 or a placebo through an IV. The main goal was to see if the drug causes any side effects and to understand how the body processes it. This information will help decide the right doses for future studies in people with COVID-19.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PA-001
- What this could lead to
- If successful, this could help determine safe doses for future studies of PA-001 as a potential treatment for COVID-19.
- What could go wrong
- This is an early Phase 1 safety study in healthy people, not patients. It does not test if PA-001 actually works against COVID-19, and many early-stage drugs fail to show benefit later.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
47 people
The number who actually took part.
- Started
-
Jul 2024
- Finished
-
Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fortrea Clinical Research Unit Inc.
Dallas, Texas, 75230, United States
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Other studies related to the condition(s) this trial covers.
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