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A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers
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.
Study details:
This study consists of 3 parts. SAD Part: The participants in the SAD cohorts of the study (Cohort 1 to Cohort 5) will receive a single dose of RSN0402 at 2, 4, 8, 12, or 16 mg dose or placebo via inhalation using a dry powder inhalant. Participants from Cohort 2 will receive a single dose of 150 mg nintedanib soft capsule after 7-day washout period.
After completion of Cohort 3, SRC will decide whether to enrol Cohort 4 sequentially or to skip Cohort 4 and enrol Cohort 5 directly based on the safety and PK data collected from the Cohort 1 to Cohort 3. If there are no safety concerns, Cohort 5 will be enrolled after Cohort 3. MAD Part: The MAD Part consists of 4 cohorts with 8 participants in each cohort.
Participants will be randomly assigned to receive RSN0402 (4, 8, 12, or 16 mg) or placebo for 7 days at a ratio of 3:1. In MAD study, the IP will be administered once daily from Day 1 to Day 7. The doses in MAD Part of the study could be adjusted at the discretion of the SRC based on the review of data from the SAD cohorts.
The dose regimen in MAD Part may also be adjusted to twice daily or another regimen if there is any concern after SRC review of the available data from SAD cohorts. The adjusted dose and dose regimen cannot exceed the maximum safety daily dose confirmed in the SAD Part.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-07-11
Primary completion: 2024-12-27
Study completion finish: 2025-02-10
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06482190
Intervention or treatment
DRUG: RSN0402 Part 1
DRUG: RSN0402 Part 2
DRUG: Placebo
Conditions
- • Idiopathic Pulmonary Fibrosis
- • Lung; Disease, Interstitial, With Fibrosis
Find a site
Closest Location:
Nucleus Network
Research sites nearby
Select from list below to view details:
Nucleus Network
Melbourne, Victoria, Australia
Nucleus Network Pty Ltd
Geelong, Victoria, Australia
Nucleus Network Pty Ltd
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: RSN0402 Part 1
| DRUG: RSN0402 Part 1
|
EXPERIMENTAL: RSN0402 Part 2
| DRUG: RSN0402 Part 2
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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. | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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 | Not Specified | 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) | Not Specified | 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 |
Frequently Asked Questions
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