PRA-216 for healthy adults and adults with mild-to-moderate asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2a study first gives single and then repeated ascending doses of PRA-216 to healthy adults to measure safety, tolerability, pharmacokinetics, and immunogenicity, using both intravenous and subcutaneous routes in Phase 1. Phase 2a is a randomized, double-blind, placebo-controlled portion that gives the selected Phase 1 dose to adults with mild-to-moderate asthma to collect additional safety, immunogenicity, pharmacokinetic, and preliminary efficacy data. Dose escalations are staggered and controlled, with close monitoring for adverse events and antibody responses. The trial uses placebo control and blinding in Phase 2a to compare outcomes robustly while early parts focus on determining a safe dose and schedule.

Why it matters

Who can join: the full rules

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

Where it's running

• Emertitus Research Sydney
  Botany, New South Wales, Australia Recruiting
• Emeritus Research Camberwell
  Camberwell, Victoria, Australia Recruiting
• Linear
  Joondalup, Western Australia, Australia Recruiting
• Linear
  Nedlands, Western Australia, Australia Recruiting
• PCRN Waikato, Nawton
  Hamilton, Auckland, New Zealand Recruiting
• Pacific Clinical Research Network-Auckland
  Takapuna, Auckland, New Zealand Recruiting

Study contacts

• Study coordinator: Linear site contact
• Email: enquiries@linear.org.au
• Phone: +61 (0)8 6382 5110

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remission of mild-to-moderate asthma in Thai adults

  This project will see how common remission is in Thai adults with mild-to-moderate asthma using symptom questionnaires, spirometry, FeNO, and a blood eosinophil count.

  Recruiting at 2 sites Thammasat University · Pathum Thani, Changwat Pathum Thani and 1 other locations · NCT07351916

• CDX-622 for adults with mild to moderate asthma

  This study will test a single IV dose of CDX-622 in adults with mild to moderate asthma to see if it is safe and how the drug behaves in the body.

  Recruiting at 4 sites Phase 1 Celldex Therapeutics · San Francisco, California and 3 other locations · NCT07330778

• Using 5HTP to Improve Asthma Symptoms in Children

  This study is testing if the amino acid supplement 5HTP can help improve lung function and reduce anxiety in children with mild to moderate asthma.

  Recruiting Phase 2 Indiana University · Indianapolis, Indiana · NCT04160910

• Imaging to see how mild asthma affects lungs in young adults

  This study tests advanced lung imaging to see if it finds airway problems in young adults with mild asthma beyond standard tests.

  Recruiting Western University, Canada · London, Ontario · NCT07143747

• Comparing two types of inhalers for mild asthma treatment

  This study is testing two different types of inhalers to see which one helps people with mild asthma breathe better.

  Recruiting Phase 1 GlaxoSmithKline · Manchester, Greater Manchester · NCT06433921

• Comparing two albuterol inhalers for treating mild asthma

  This study is testing if a new albuterol inhaler works just as well as an existing one for adults with mild asthma.

  Recruiting at 4 sites Intech Biopharm Ltd. · Ahmedabad and 11 other locations · NCT04912596

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.