Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482190
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-25
Brief Title:
A Study to Evaluate Safety Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers
Sponsor:
Shenzhen Resproly Biopharmaceutical Co Ltd
Organization:
Shenzhen Resproly Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 1 Randomized Double Blinded Placebo Controlled First-in Human Study to Evaluate the Safety Tolerability and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of RSN0402 in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 31 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
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 31 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None