L608 liposomal inhaled iloprost in healthy adults

A Phase 1, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of L608 for Inhalation in Healthy Participants

This trial will test single ascending inhaled doses of L608 (15–30 μg) in healthy adults to see if it is safe and how the body handles it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Pharmosa Biopharm Inc. (Industry-sponsored)
• Locations: 1 site (Christchurch)
• Trial ID: NCT06429930 on ClinicalTrials.gov

What this trial studies

L608 is a liposomal formulation of iloprost designed to provide sustained pulmonary delivery and reduce dosing frequency and peak-related side effects. This Phase 1, randomized, double-blind, placebo-controlled study enrolls healthy adults in Christchurch, New Zealand and uses a single ascending dose design with sentinel dosing for each cohort. Participants will receive inhaled L608 or placebo and be followed for safety, tolerability, and pharmacokinetics. The study compares plasma drug levels and adverse events across dose levels to inform further development.

Who should consider this trial

Good fit: Healthy adults aged 18–65 with BMI 18.5–32 kg/m2, weighing at least 50 kg, who are non-smokers or light former smokers and (if female) not pregnant and willing to use effective contraception are ideal candidates.

Not a fit: People with active respiratory diseases (asthma, COPD, sleep apnea), bleeding or coagulation disorders, significant sensitivity to study components, current tobacco use, or who are pregnant/lactating are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, L608 could allow less frequent inhalations and reduce peak-related side effects (for example, hypotension) while maintaining therapeutic iloprost levels.

How similar studies have performed: Inhaled iloprost is an established PAH therapy, but liposomal sustained-release versions like L608 are novel and currently have limited clinical data.

Eligibility criteria

Key Inclusion Criteria:

1. Men and women aged between 18 and 65 (inclusive) at the time of Screening visit.
2. Participants with Body Mass Index (BMI) of ≥18.5 and ≤32.0 kg/m2 and weight of at least 50 kg at Screening.
3. Non-smokers or former smokers who have smoked ≤ 100 cigarettes in their lifetime and have not consumed any tobacco or tobacco-containing products for at least 3 months prior to Screening.
4. Females must not be pregnant or lactating and must use acceptable, highly effective double contraception from Screening until 3 months after the last dose of the Investigational product.

Key Exclusion Criteria:

1. Participants with contraindications or sensitivity to any components of the study treatment.
2. Participants with histories or active conditions of unexplained bleeding events, hemoptysis, abnormal bleeding tendencies, and/or coagulation disorders.
3. Participants with histories or active conditions of asthma, sleep apnea, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, bronchiectasis, bronchospasm, and/or reactive airway. Subjects who have had childhood asthma which have resolved as deemed by the PI can be considered.
4. Participants with histories or active conditions of myocardial infarction (MI), cerebrovascular accident (CVA), coronary artery disease (CAD), unstable angina, heart failure, significant cardiac arrhythmias, congenital or acquired valvular heart disease with clinically insignificant symptom, suspected lung congestion, and/or pulmonary arterial hypertension (PAH) causing by venous thromboembolism.
5. Participants with systolic blood pressure \< 90 mmHg or \> 140 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 95 mmHg at Screening or check-in visit.
6. Participants with FEV1 less than 80% predicted, FVC ˂ 80% predicted, or resting oxygen saturation less than 95% at Screening or check-in visit.
7. Participants with histories of drug or alcohol abuse within 1 year prior to subject check-in (Day -1). Regular alcohol consumption defined as \> 14 standard drinks per week for female and \> 21 standard drinks per week for male.
8. Consumption of products containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and products containing grapefruit and/or pomelo (shown to inhibit cytochrome P450 \[CYP\] 3A4 activity) within 10 days prior to drug administration, and/or participants unwilling to refrain from consumption of alcohol from 48 hours before dosing to Day 14.
9. Receipt of blood products within 2 months prior to dosing.
10. Positive results of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and pregnancy test.
11. Blood donation or significant blood loss (\>480 ml) within 3 months prior to Screening.
12. Participants unwilling to refrain from strenuous exercises from 7 days prior to dosing until the EOS visit.
13. Participants planning to receive a tattoo, body piercing, or undergo any invasive procedure during the study period.

Where this trial is running

Christchurch

• NZCR Ltd (New Zealand Clinical Research) — Christchurch, New Zealand (Recruiting)

Study contacts

• Study coordinator: Pei Kan, PhD

Conditions Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Pharmaceutical Solutions