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New COVID-19 drug candidate passes first safety check in healthy volunteers

NCT ID NCT07518771

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.