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New asthma drug shows promise in early human trials

NCT ID NCT07245368

Symptom relief Sponsor: Prana Therapies Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests a new drug called PRA-216 in two phases. First, healthy volunteers receive single or multiple doses to check safety. Then, people with mild-to-moderate asthma receive the drug to see if it reduces airway inflammation and improves asthma control. The goal is to find a safe and effective treatment for asthma symptoms.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

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 to 65 years

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.

Phase 1 Inclusion Criteria: * Age 18-65 * Must be in good health with no significant medical history * Willing and able to attend all study visits, comply with study requirements * Able and willing to provide written informed consent Exclusion Criteria: * Evidence of clinically significant condition or disease * Any physical or psychological condition that prohibits study completion * Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent * History of severe allergic reactions or hypersensitivity * Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing Phase 2a Inclusion criteria: * Age 18-65 * Must be in good health with no significant medical history * Willing and able to attend all study visits, comply with study requirements. * Able and willing to provide written informed consent * Documented asthma diagnosis prior for at least 12 months prior to screening. * Symptomatic asthma * Currently receiving maintenance asthma medications Exclusion Criteria: * Evidence of clinically significant condition or disease * Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent * Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing * History of severe allergic reactions or hypersensitivity * Current or former smoker with a smoking history of ≥10 pack-years * Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening * Other investigational agent(s) within 30 days of dosing

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mild to moderate asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Emeritus Research Camberwell

    RECRUITING

    Camberwell, Victoria, 3124, Australia

  • Emertitus Research Sydney

    RECRUITING

    Botany, New South Wales, 2019, Australia

  • Linear

    RECRUITING

    Joondalup, Western Australia, 6027, Australia

    Contact Email: •••••@•••••

  • Linear

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

    Contact Email: •••••@•••••

  • Monash Health

    NOT_YET_RECRUITING

    Clayton, Victoria, 3168, Australia

  • PCRN Waikato, Nawton

    RECRUITING

    Hamilton, Auckland, 3200, New Zealand

    Contact Email: •••••@•••••

  • PCRN Wellington, Ebdentown

    RECRUITING

    Upper Hutt, Auckland, 5018, New Zealand

    Contact Email: •••••@•••••

  • Pacific Clinical Research Network-Auckland

    RECRUITING

    Takapuna, Auckland, 0622, New Zealand

    Contact Email: •••••@•••••

More trials for these conditions

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