Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532396
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Blind Multiple Ascending Dose Phase 1 Study to Evaluate the Safety Tolerability and Pharmacokinetics of QRL-101 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
QRL-101-03 is a multiple ascending dose MAD study to evaluate the safety tolerability and pharmacokinetics PK of QRL-101 in healthy participants QRL-101-03 is a follow-on study to QRL-101-01 an ongoing Phase 1 single ascending dose study to determine the safety tolerability and PK profile of QRL-101 after a single dose ClinicalTrialsgov ID NCT05667779
Detailed Description:
Phase 1 single-site multiple-dose study to evaluate the safety tolerability and PK of multiple ascending doses of QRL-101 in healthy participants Up to 5 cohorts of 8 participants each randomized 62 QRL-101 placebo will be tested The approximate total duration of study participation for each participant may be up to 39 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None