Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults

NCT06429930 | Recruiting Phase 1

• 1 other identifier: PBI-L608-B12
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is the second single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with dose level ranging from 15 μg to 30 μg.

Conditions

Pulmonary Arterial Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Percentage of participants with DLT

  DLT: Dose-limiting toxicity

  7 days after administration

• Percentage of participants with TEAEs and SAEs

  TEAEs: treatment emergent adverse events; SAEs: serious adverse events

  2 weeks after administration

• Frequency and severity of TEAEs and SAEs

  TEAEs: treatment emergent adverse events; SAEs: serious adverse events

  2 weeks after administration

Secondary Outcomes (12)

• AUC0-t

  24 hours after administration

• AUC0-inf

  24 hours after administration

• %AUCextrap

  24 hours after administration

• Cmax

  24 hours after administration

• Tmax

  24 hours after administration

Study Arms (2)

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).

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).

Drug: Placebo Solution

Interventions

Placebo Solution DRUG

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

L608 Liposomal inhalation suspension DRUG

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.

L608 Liposomal inhalation suspension

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Pharmosa Biopharm Inc.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

NZCR Ltd (New Zealand Clinical Research)

Christchurch, 8011, New Zealand

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Pei Kan, PhD

CONTACT

+886-2-2782-7561; peikan@pharmosa.com.tw

Sydney Chuang

CONTACT

+886-2-2782-7561; sydney@pharmosa.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blinded, single ascending dose escalation design. After confirmation of eligibility, subjects will be randomized at a ratio of 1:1 (for sentinel dosing) followed by 5:1 for rest of the cohorts to receive the assigned dose of L608 or placebo.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Placebo-controlled, double-blinded, single ascending dose escalation

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: April 11, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

NZ (1)