Healthy Adult ParticipantsPhase 1NCT06429930
Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
A Phase 1 study testing L608 Liposomal inhalation suspension in people with Healthy Adult Participants, run by Pharmosa Biopharm Inc. at 1 site in New Zealand.
Trial summary
This is a single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with dose level ranging from 10 μg to 20 μg. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- L608 Liposomal inhalation suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNew Zealand
- Study dates
- 11 Apr 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 65 (inclusive) at the time of Screening visit.
- Participants with Body Mass Index (BMI) of ≥18.5 and ≤32.0 kg/m2 and weight of at least 50 kg at Screening.
- 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.
- 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.
Who cannot join
- Participants with contraindications or sensitivity to any components of the study treatment.
- Participants with histories or active conditions of unexplained bleeding events, hemoptysis, abnormal bleeding tendencies, and/or coagulation disorders.
- 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.
- 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.
- Cohorts A1 and B1: 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.
- Cohorts B2, B3, C1 and C2: Participants with systolic blood pressure < 110 mmHg or > 140 mmHg and/or diastolic blood pressure < 50 mmHg or > 95 mmHg at Screening, check-in visit or predose on Day1.
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- Participants with FEV1 less than 80% predicted, FVC ˂ 80% predicted, or resting oxygen saturation less than 95% at Screening or check-in visit.
- 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.
- 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.
- Receipt of blood products within 2 months prior to dosing.
- Positive results of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and pregnancy test.
- Blood donation or significant blood loss (>480 ml) within 3 months prior to Screening.
- Participants unwilling to refrain from strenuous exercises from 7 days prior to dosing until the EOS visit.
- Participants planning to receive a tattoo, body piercing, or undergo any invasive procedure during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site, 1 recruiting
- Recruiting
NZCR Ltd (New Zealand Clinical Research)
Christchurch, 8011
Christopher John Wynne, +64 3 372-9477, chris.wynne@nzcr.co.nz
About this study
Official title: 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 is a single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with dose level ranging from 10 μg to 20 μg.
Read the detailed description
L608 inhalation Suspension (L608) is developed by Pharmosa Biopharm Inc. (PBI) as a new liposomal Iloprost formulation for inhalation use in the treatment of patients with WHO Group 1 PAH. As a liposomal formulation of iloprost, L608 is intended to reduce the dosing frequency, as well as provide sustained and selective release along with achieving therapeutically relevant iloprost level.
This Phase I, randomized, double-blinded, placebo-controlled study will be conducted in healthy participants in New Zealand to evaluate the safety, tolerability, and pharmacokinetic of L608.
- Conditions
- Healthy Adult Participants
- Being tested
- L608 Liposomal inhalation suspension, Placebo Solution
- Keywords
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Diseases, Pharmaceutical Solutions
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L608 Liposomal inhalation suspensionDrug
Participants will be randomized at a ratio of 1:1 (for sentinel dosing) followed by 5:1 for the rest of the cohort to receive the assigned dose of L608 or placebo.
Placebo SolutionDrug
Participants will be randomized at a ratio of 1:1 (for sentinel dosing) followed by 5:1 for the rest of the cohort to receive the assigned dose of L608 or placebo.
| Study group | Role | What they receive |
|---|---|---|
| L608 Liposomal inhalation suspension | Experimental | Eight participants will be enrolled in each cohort and be randomized to receive assigned dose of L608 or placebo (6:2). Receives: Drug: L608 Liposomal inhalation suspension |
| Placebo | Placebo comparator | Eight participants will be enrolled in each cohort and be randomized to receive assigned dose of L608 or placebo (6:2). Receives: Drug: Placebo Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with DLT
DLT: Dose-limiting toxicity
Measured: 7 days after administration
Percentage of participants with TEAEs and SAEs
TEAEs: treatment emergent adverse events; SAEs: serious adverse events
Measured: 2 weeks after administration
Frequency and severity of TEAEs and SAEs
TEAEs: treatment emergent adverse events; SAEs: serious adverse events
Measured: 2 weeks after administration
Secondary outcomes (12)
AUC0-t
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration
Measured: 24 hours after administration
AUC0-inf
Area under the plasma concentration-time curve from time 0 to infinity
Measured: 24 hours after administration
%AUCextrap
AUC extrapolated from the last measurable concentration to infinity as a percentage of total AUC
Measured: 24 hours after administration
Cmax
Maximum observed plasma concentration
Measured: 24 hours after administration
Tmax
Time to reach the maximum observed plasma concentration
Measured: 24 hours after administration
T1/2
Apparent plasma terminal elimination half-life
Measured: 24 hours after administration
CL/F
Apparent total plasma clearance
Measured: 24 hours after administration
Vz/F
Apparent volume of distribution during the terminal phase
Measured: 24 hours after administration
λz
Terminal elimination rate constant
Measured: 24 hours after administration
Cmax/D
Dose-normalized Cmax.
Measured: 24 hours after administration
AUC0-t/D
Dose-normalized AUC0-t.
Measured: 24 hours after administration
AUC0-inf/D
Dose-normalized AUC0-inf.
Measured: 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start11 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized, Placebo-controlled, double-blinded, single ascending dose escalation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmosa Biopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429930
- Sponsor's protocol ID
- PBI-L608-B12
- Status last verified
- Jul 2026
- First submitted
- 21 May 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06429930
- Acronym / sponsor ID
- PBI-L608-B12
- Conditions
- Healthy Adult Participants
- Keywords
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Diseases, Pharmaceutical Solutions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pharmosa Biopharm Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with dose level ranging from 10 μg to 20 μg.
Detailed description
L608 inhalation Suspension (L608) is developed by Pharmosa Biopharm Inc. (PBI) as a new liposomal Iloprost formulation for inhalation use in the treatment of patients with WHO Group 1 PAH. As a liposomal formulation of iloprost, L608 is intended to reduce the dosing frequency, as well as provide sustained and selective release along with achieving therapeutically relevant iloprost level.
This Phase I, randomized, double-blinded, placebo-controlled study will be conducted in healthy participants in New Zealand to evaluate the safety, tolerability, and pharmacokinetic of L608.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Placebo-controlled, double-blinded, single ascending dose escalation
| Arm | Type | Receives |
|---|---|---|
| L608 Liposomal inhalation suspension | Experimental | Drug: L608 Liposomal inhalation suspensionEight participants will be enrolled in each cohort and be randomized to receive assigned dose of L608 or placebo (6:2). |
| Placebo | Placebo comparator | Drug: Placebo SolutionEight participants will be enrolled in each cohort and be randomized to receive assigned dose of L608 or placebo (6:2). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged between 18 and 65 (inclusive) at the time of Screening visit.
- Participants with Body Mass Index (BMI) of ≥18.5 and ≤32.0 kg/m2 and weight of at least 50 kg at Screening.
- 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.
- 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 (14 listed)
- Participants with contraindications or sensitivity to any components of the study treatment.
- Participants with histories or active conditions of unexplained bleeding events, hemoptysis, abnormal bleeding tendencies, and/or coagulation disorders.
- 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.
- 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.
- Cohorts A1 and B1: 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L608 Liposomal inhalation suspensionParticipants will be randomized at a ratio of 1:1 (for sentinel dosing) followed by 5:1 for the rest of the cohort to receive the assigned dose of L608 or placebo. | Drug | L608 Liposomal inhalation suspension |
| Placebo SolutionParticipants will be randomized at a ratio of 1:1 (for sentinel dosing) followed by 5:1 for the rest of the cohort to receive the assigned dose of L608 or placebo. | Drug | Placebo |
Primary outcome
Percentage of participants with DLT
Time frame: 7 days after administration
DLT: Dose-limiting toxicity
Percentage of participants with TEAEs and SAEs
Time frame: 2 weeks after administration
TEAEs: treatment emergent adverse events; SAEs: serious adverse events
Frequency and severity of TEAEs and SAEs
Time frame: 2 weeks after administration
TEAEs: treatment emergent adverse events; SAEs: serious adverse events
12 secondary outcomes
AUC0-t
Time frame: 24 hours after administration
AUC0-inf
Time frame: 24 hours after administration
%AUCextrap
Time frame: 24 hours after administration
Cmax
Time frame: 24 hours after administration
Tmax
Time frame: 24 hours after administration
T1/2
Time frame: 24 hours after administration
CL/F
Time frame: 24 hours after administration
Vz/F
Time frame: 24 hours after administration
λz
Time frame: 24 hours after administration
Cmax/D
Time frame: 24 hours after administration
AUC0-t/D
Time frame: 24 hours after administration
AUC0-inf/D
Time frame: 24 hours after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L608 Liposomal inhalation suspension in people with Healthy Adult Participants, run by Pharmosa Biopharm Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei Kan, PhD (+886-2-2782-7561 ext. 102, peikan@pharmosa.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with DLT (time frame: 7 days after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.