Randomized, FIH, SAD/MAD, Safety PK Study in Healthy Adult Subjects.

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Phase 1a, First-in-Man, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Safety, Tolerability and Pharmacokinetic Study of a Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Healthy Adult Subjects.

• IRAS ID

  274428

• Contact name

  Devinda Weeraratne

• Contact email

  devinda.weeraratne@celerion.com

• Sponsor organisation

  Lung Therapeutics Inc

• Eudract number

  2018-003372-12

• Duration of Study in the UK

  0 years, 5 months, 15 days

• Research summary

  Research Summary

  Lung therapeutics are developing a novel therapy ( LTI-03 ) for Idiopathic Pulmonary fibrosis (IPF). IPF is a progressive, fatal, age-associated lung disease with a median survival from diagnosis of 2-4 years and an incidence of 2.8 to 18 cases per 100,000 people per year in Europe and North America.
  LTI-03 is an oligopeptide representing 7 amino acids and is in an inhaled formulation.

  Approximately 56 healthy volunteers are planned in total. Approximately 32 subjects will be enrolled in the SAD cohorts and approximately 24 subjects will be enrolled the MAD cohorts of the study. Each cohort will include eight subjects (six on active medication and two on placebo).
  In the Single Ascending Dose (SAD)each subject’s duration of participation may be up to approximately 35 days, including up to 28 days for the Screening period, 1 day for study treatment, and 7 days for safety follow-up.
  In the Multiple Ascending Dose (MAD)each subject’s duration of participation may be up to approximately 49 days, including up to 4 weeks for the Screening period, 2 weeks for study treatment, and 7 days for safety follow-up.
  This study will be conducted in one site : Celerion Clinical Research, Belfast, Northern Ireland, UK

  Summary of Results

  The study enrolled 71 participants and overall, administration of single doses of inhaled LTI-03 was generally safe and well tolerated by the healthy adult participants at doses ranging from 20 to 80 mg on one day. Administration of multiple doses of inhaled LTI-03 were generally safe and will tolerated by health adult participants at dose ranging from 2.5 mg per day to 5 mg twice per day for a total of 14 days.

• REC name

  HSC REC A

• REC reference

  19/NI/0200

• Date of REC Opinion

  11 Dec 2019

• REC opinion

  Further Information Favourable Opinion