Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05984992
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-07-26
Brief Title:
The First-in-human Study of SRN-001 in Healthy Participants
Sponsor:
siRNAgen Therapeutics Inc
Organization:
siRNAgen Therapeutics Inc
Study Overview
Official Title:
A Randomized Double-blinded Placebo-controlled Single Ascending Dose Study to Assess the Safety Tolerability and Pharmacokinetics of SRN-001 in Healthy Participants
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
SRN-001 is a novel small interfering RNA siRNA drug being developed to treat fibrosis using Self Assembled Micelle inhibitory ribonucleic acid SAMiRNA technology Amphiregulin AREG is a growth factor involved in fibroblast proliferation and myofibroblast transformation which is the hallmark of fibrosis in lung and kidney tissues AREG is a downstream gene overexpressed by Transforming growth factor-β TGF-β during fibrosis promoting fibroblast to myofibroblast transition FMT SRN-001 is designed to downregulate generating amphiregulin by RNA interference RNAi The goal of this clinical trial is to evaluate safety tolerability and pharmacokinetics in healthy participants This trial is first-in-human clinical trial to develop SAMiRNA to utilize as therapeutic use
Detailed Description:
Participants with part in consent will be enrolled in a phase 1a study of SRN-001 Prior to initiation of treatment participants will undergo several screening test for checking their condition of health There is no specific test comparing with the general other clinical trial in healthy volunteers They will be randomized into two groups active drug and inactive placebonormal saline as ratio 21 Starting dose is planned 15mg For confirming maximal tolerable dose dose will be escalated when no dose-limiting toxicity DLT confirmed Each cohort will take single dose and for 4 weeks safety observation will be taken If safety abnormality will be retained in 4 weeks the participants safety observation will be prolonged by the end of the adverse event once 2 weeks
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