Phase 2 Asthma Trial, Recruiting NCT07245368 Sponsor: Prana Therapies Inc Condition: Asthma
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Phase 2 Asthma Trial, Recruiting

NCT07245368
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Phase 1

Who might be able to join this trial:

  • People aged between 18 and 65 years old
  • People who are generally healthy with no significant medical history
  • People who are able and willing to attend all scheduled study visits and follow the study requirements
  • People who are willing to sign a written consent form agreeing to take part

Who may not be able to join:

  • People who have a significant health condition or disease
  • People who have a physical or mental health condition that would prevent them from completing the study
  • People with a known history of illegal drug use, drug abuse, harmful alcohol use, alcoholism, or use of tobacco or nicotine products in the 3 months before the first study dose
  • People who have had severe allergic reactions or serious sensitivities in the past
  • People who have donated or lost one unit or more of blood or plasma in the 2 months before dosing

Phase 2a

Who might be able to join this trial:

  • People aged between 18 and 65 years old
  • People who are generally healthy with no significant medical history
  • People who are able and willing to attend all scheduled study visits and follow the study requirements
  • People who are willing to sign a written consent form agreeing to take part
  • People who have had a documented asthma diagnosis for at least 12 months before the screening visit
  • People who are currently experiencing asthma symptoms
  • People who are currently taking regular asthma maintenance medication

Who may not be able to join:

  • People who have a significant health condition or disease
  • People with a known history of illegal drug use, drug abuse, harmful alcohol use, alcoholism, or use of tobacco or nicotine products in the 3 months before the first study dose
  • People who have donated or lost one unit or more of blood or plasma in the 2 months before dosing
  • People who have had severe allergic reactions or serious sensitivities in the past
  • People who have smoked 10 or more pack-years (confirm with trial site for clarification on how this is calculated)
  • People who have received immune-suppressing medications or biologic treatments for asthma within 6 months before the screening visit
  • People who have taken part in another clinical trial and received an investigational treatment within 30 days before dosing

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +61 (0)8 6382 5110

Australian sites

Emertitus Research Sydney, Botany, New South Wales
0289648186
Emeritus Research Camberwell, Camberwell, Victoria
0395096166
Linear, Joondalup, Western Australia
011 61 88 6382 5110
Linear, Nedlands, Western Australia
08 6382 5110

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Prana Therapies Inc
Registry
ClinicalTrials.gov
Start date
4 November 2025
Est. completion
1 October 2026

Where this trial is recruiting

🇦🇺 Australia 🇳🇿 New Zealand

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm); Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) of multiple doses of PRA-216 in healthy volunteers (MAD arm); Phase 2a: To evaluate the effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in asthma participants

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov