Phase 1 Pulmonary Hypertension Trial, Recruiting NCT06429930 Sponsor: Pharmosa Biopharm Inc. Condition: Pulmonary Hypertension
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Phase 1 Pulmonary Hypertension Trial, Recruiting

NCT06429930
Recruiting Phase 1

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

Who might be able to join this trial:

  • Adults between 18 and 65 years old (inclusive) at the time of the screening visit
  • People with a body mass index (BMI) between 18.5 and 32.0, and who weigh at least 50 kg at screening
  • Non-smokers, or former smokers who have smoked no more than 100 cigarettes in their entire lifetime and have not used any tobacco or tobacco-containing products for at least 3 months before screening
  • Women who are not pregnant or breastfeeding, and who agree to use two highly effective forms of contraception from screening until 3 months after the last dose of the study treatment

Who may not be able to join:

  • People who are allergic or sensitive to any ingredients in the study treatment
  • People with a history of, or currently experiencing, unexplained bleeding, coughing up blood, unusual bleeding tendencies, or blood clotting disorders
  • People with a history of, or currently experiencing, asthma, sleep apnea, COPD (a chronic lung condition), pulmonary fibrosis, bronchiectasis, bronchospasm, or reactive airway disease — though people whose childhood asthma has fully resolved may be considered (confirm with trial site)
  • People with a history of, or currently experiencing, heart attack, stroke, coronary artery disease, unstable chest pain, heart failure, significant irregular heartbeat, heart valve disease, suspected fluid in the lungs, or a type of high blood pressure affecting the lungs caused by blood clots
  • People whose blood pressure reading at screening or check-in falls outside an acceptable range — specifically, top number below 90 or above 140, or bottom number below 50 or above 95
  • People whose lung function tests or resting blood oxygen levels fall below acceptable levels at screening or check-in (confirm with trial site for specific values)
  • People with a history of drug or alcohol misuse in the year before check-in, or those who regularly drink more than 14 standard drinks per week (for women) or more than 21 standard drinks per week (for men)
  • People who have consumed caffeine, poppy seeds, or alcohol within 48 hours before dosing, or grapefruit or pomelo within 10 days before dosing, or those unwilling to avoid alcohol from 48 hours before dosing through to Day 14
  • People who have received blood products within 2 months before dosing
  • People who test positive for HIV, hepatitis B, hepatitis C, or pregnancy
  • People who have donated blood or had significant blood loss (more than 480 ml) within 3 months before screening
  • People unwilling to avoid intense physical exercise from 7 days before dosing until the end of the study
  • People planning to get a tattoo, body piercing, or any invasive procedure during the study period

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 23 July 2026
Phase 1: approximately ~10% 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: +886-2-2782-7561

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 1
Sponsor
Pharmosa Biopharm Inc.
Registry
ClinicalTrials.gov
Start date
11 April 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇳🇿 New Zealand

Primary endpoints

Percentage of participants with DLT; Percentage of participants with TEAEs and SAEs; Frequency and severity of TEAEs and SAEs

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: 23 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