A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers
NCT Number: NCT06482190
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis|Lung; Disease, Interstitial, With Fibrosis
Interventions: DRUG: RSN0402 Part 1|DRUG: RSN0402 Part 2|DRUG: Placebo
Sponsor: Shenzhen Resproly Biopharmaceutical Co., Ltd
Collaborators: Resproly Australia Pty Ltd
Sex: ALL
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-11
Completion Date: 2025-02-10
Locations: Nucleus Network Pty Ltd, Geelong, Victoria, 3220, Australia|Nucleus Network, Melbourne, Victoria, 3004, Australia|Nucleus Network Pty Ltd, Melbourne, 3004, Australia

Summary:
This is a phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers. A total of about 72 participants are expected to be enrolled.

Primary Outcome Measures: Number of participants with Treatment emergent Adverse events (TEAEs), TEASs will be collected to assess participant's safety after RSN0402 administration in both Single ascending dose (SAD) and multiple ascending dose (MAD)., SAD - From Screening to Day 14 (end of study); MAD - From Screening to Day 13 (end of study)|Number of participants with changes in physical examination, Full physical examination will comprise a routine medical examination including examination of head, eyes, ears, nose, throat and neck, abdomen, the respiratory system, central and peripheral nervous system, cardiovascular system, gastrointestinal system including mouth, musculoskeletal system, and skin. Brief physical examination will include at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen)., SAD- From Screening to Day 14 (end of study) post dose; MAD - At screening, Day -2, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 13 (end of study) post dose.|Number of participants with changes in serum blood parameters, Serum blood parameters include hematology, biochemistry, coagulation, SAD- At Screening, Day -2, Day 3, Day 7, Day 10 and Day 14 (end of study) post dose; MAD- At Screening, Day -2, Day 3, Day 6, Day 9 and Day 13 (end of study) post dose.|Number of participants with changes in Urine parameters, Urine cotinine test and urine pregnancy test will be assessed, SAD: Urine pregnancy test will be conducted on Day -2 and Day 7 and Urine cotinine test in screening, Day -2 and Day 7 post first dose. MAD: Urine pregnancy test will be conducted on Day -2, Urine cotinine test in screening and Day -2.|Number of participants with changes in vital signs, Heart rate, systolic/diastolic blood pressure, respiratory rate, oxygen saturation, and temperature, SAD- At Screening, Day-2, Day 1, Day 2, Day 3, Day 7, Day 8, Day 9, Day 10 and Day 14 (end of study) post dose; MAD - At screening, Day - 2, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 13 (end of study) post dose.|Number of participants with change in Absolute Forced Expiratory Volume in 1 second (FEV1) >10%, Spirometry will be conducted in accordance with ATS and ERS guidelines, SAD- At Screening, Day -2, Day 1, Day 2, Day 3, Day 7, Day 8, Day 9, Day 10 and Day 14 (end of study) post dose; MAD - At screening, Day- 2, Day 1, Day 3, Day 6, Day 9 and Day 13 (end of study) post dose.
Secondary Outcome Measures: Changes in AUC 0-inf (Area under curve from time 0 to infinity) of RSN0402 with 5 different doses of SAD.PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing on Day 3., SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10 post first dose; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in AUC 0-t (Area under curve from time 0 to last measurable concentration) of RSN0402., PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose., SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in Cmax (Maximum observed plasma concentration) of RSN0402, PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose., SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in Tmax (Time to Maximum) of RSN0402, PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose., SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in t1/2 (Apparent terminal elimination half-life) of RSN0402, PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose., SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in CL/F (Apparent systemic clearance) of RSN0402, PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose., SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in Vz/F (Apparent volume of distribution) of RSN0402, PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose., SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in AUCτ(Area under curve) of RSN0402, SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in Cmax,ss (Cmax at steady state) of RSN0402, SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in Ctrough (trough concentration) of RSN0402, SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in Tmax,ss (Tmax at steady state) of RSN0402, SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Changes in Vss/F (Apparent steady state volume of distribution) of RSN0402, SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose|PK parameter: Change from Baseline in QT interval corrected by Fridericia's formula (QTcF), SAD - At Screening, Day-2, Day 1, Day 2, Day 3 and Day 7 (end of study) post dose; MAD - At screening, Day 2, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 13 (end of study) post dose