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Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult Subjects

Study Purpose

The current study will investigate the initial safety, tolerability, and PK profile of inhaled LTI-03 in healthy volunteers. In order to minimize exposure, the study will first test single ascending doses (SAD) of LTI-03 followed by multiple ascending dose (MAD) cohorts. Findings from this study will direct the clinical development of LTI-03 for the treatment of IPF. The study subject population will include normal healthy male and female volunteers between 18 and 55 years of age (inclusive). Consistent with other trials involving inhaled medication, subjects must have normal pulmonary function at Screening and will be excluded if they have a history of active or recurring allergies, asthma, chronic obstructive pulmonary disease (COPD), chronic sinus drainage, chronic or acute cough or other respiratory condition deemed exclusionary by the Investigator. History of liver dysfunction or elevated bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values at Screening will also be grounds for exclusion.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Non-smoker (no use of tobacco products within 6 months prior to dosing) with a negative urine cotinine test at Screening or Day -1. 2. Age of 18-55 years (inclusive) 3. Body mass index (BMI) of 18
  • - 30.5 kg/m2 (inclusive) 4.
Body weight > 50 kg. 5. Willing and able to provide written informed consent.

Exclusion Criteria:

1. History of asthma. 2. Presence of active or recurring allergies, asthma, chronic obstructive pulmonary disease (COPD), chronic sinus drainage, chronic or acute cough or other respiratory condition deemed exclusionary by the Investigator or designee. 3. Pulmonary infiltrate or pneumonia within 6 months prior to dosing or acute infection within 14 days prior to dosing. 4. History of significant allergy or anaphylaxis. 5. Any clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease (excluding hay fever), as determined by the Investigator or designee. 6. Any current clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, and clinical laboratory tests (hematology, coagulation, urinalysis, clinical chemistries) at Screening or Day -1, as determined by the Investigator or designee. 7. Any clinically significant illness and/or surgery within 28 days prior to dosing. 8. Febrile illness within 7 days prior to dosing. 9. Weight loss > 5 kg within 28 days prior to dosing. 10. Clinically significant 12-lead electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg, or heart rate < 45 beats per minute [bpm] or > 100 bpm) at Screening or Day -1, as determined by the Investigator or designee. 11. History of, or existing severe, acute, chronic, and/or psychiatric medical condition(s), laboratory abnormality, or other medical concerns that may increase the risk associated with study participation or IMP administration which, in the judgment of the Investigator, would make the subject inappropriate for entry into the study. 12. History of cancer with the exception of adequately treated basal cell or squamous cell carcinoma of the skin. 13. Hemoglobin < lower limit of normal (LLN) 14. Abnormal liver function- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of the normal range (ULN)
  • - total bilirubin > 1.5 times ULN.
15. Abnormal renal function: estimated glomerular filtration rate (eGFR) (modification of diet and renal disease [MDRD]) < 55 mL/min/1.73 m2. 16. Pulmonary function outside the normal range, including forced expiratory volume 1 (FEV1), forced vital capacity (FVC) each < 80% of predicted or FEV1/FVC ratio of ≤ 0.7 at Screening. 17. Inability to use study inhaler device appropriately. 18. Positive test results for human immunodeficiency virus (HIV) HIV-1/HIV-2 antibodies, hepatitis B surface antigen (HBsAG) or hepatitis C virus antibody (HCV-AB) Concurrent Intake of Other Substances. 19. History of alcohol abuse within one year prior to Screening or regular use of alcohol of ≥ 14 units of alcohol per week for females and ≥ 21 units of alcohol for males (1 unit = 150 mL wine, 360 mL beer or 45 mL of 40% alcohol) within 6 months prior to dosing or a positive urine alcohol test at Screening or Day -1. 20. History of drug abuse or misuse within 5 years prior to dosing or a positive urine drug test at Screening or Day -1. 21. Inability or unwillingness to abstain from alcohol or any drug of abuse for 48 hours prior to the first dose until completion of the Day 8 visit for the SAD and Day 21 visit for the MAD. 22. Exposure to any live vaccines within 28 days prior to dosing. 23. Treatment with an investigational product within 30 days or 5 half-lives (whichever is longer) prior to dosing. 24. Use of prescription or non-prescription medications and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to dosing. Approved medications taken for contraception are permitted. 25. Positive serum pregnancy test in female subjects. 26. Female subjects who are lactating. 27. Female subjects of childbearing potential (FOCBP) and men with partners of childbearing potential who do not agree to use an acceptable form of contraception for the duration of study treatment and for at least 90 days after the last dose of study medication. Male subjects who do not agree to refrain from donating sperm during this same period. 28. Not eligible to receive study medication within 2 weeks of receiving a COVID-19 vaccination, including an initial, second, or booster injection. NOTE: Female who is surgically sterile or post-menopausal for at least 12 months with follicle stimulating hormone (FSH) > 30 mIU/ml, are not considered to be of childbearing potential.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04233814
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lung Therapeutics, Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Devinda Weeraratne, MD
Principal Investigator Affiliation Celerion
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Sham Comparator: Placebo

Matching placebo is a micronized lactose powder administered by inhalation through a dry powder inhaler (DPI)

Experimental: SAD Cohort 1

LTI-03 20 mg delivered qd x 1 day via DPI

Experimental: SAD Cohort 2

LTI-03 40 mg delivered qd x 1 day via DPI

Experimental: SAD Cohort 3

LTI-03 80 mg delivered qd x 1 day via DPI

Experimental: MAD Cohort 1

LTI-03 dose at 20mg once daily x 14 days via DPI

Experimental: MAD Cohort 2

LTI-03 dose at 40mg once daily x 14 days via DPI

Experimental: MAD Cohort 3

LTI-03 dose at 2.5 mg once daily x 14 days via DPI

Experimental: MAD Cohort 4

LTI-03 dose at 5 mg once daily x 14 days via DPI

Experimental: MAD Cohort 5

LTI-03 dose at 5 mg twice daily x 14 days via DPI

Interventions

Drug: - Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03)

LTI-03, a Caveolin-1 scaffold protein-derived 7-amino acid peptide to be administered as a dry powder by inhalation through a dry powder inhaler.

Drug: - Placebo

Matching placebo is micronized lactose powder administered by inhalation through a dry powder inhaler.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Celerion, Belfast, United Kingdom

Status

Recruiting

Address

Celerion

Belfast, , BT9 6AD

Site Contact

Grace Taylor-Holmes

grace.taylor-holmes@celerion.com

3039026306