Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-02 @ 1:25 PM
Study NCT ID:
NCT06243835
Status:
TERMINATED
Last Update Posted:
2025-10-24
First Post:
2024-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test the Effects of Kindolor at Different Doses in Healthy Adults
Sponsor:
Lohocla Research Corporation
Organization:
Study Overview
Official Title:
A Phase 1a Randomized, Double-blind, Placebo-controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Kindolor Tosylate in Healthy Adults
Status:
TERMINATED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated by sponsor due to low drug bioavailability; no safety concerns were noted.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to test Kindolor in healthy adults. The main questions it aims to answer are:
* What is the safe dose of Kindolor in healthy volunteers?
* How is Kindolor metabolized by the human body?
Participants will undergo medical tests before and after receiving Kindolor or a placebo to see if there is any difference between the groups.
* What is the safe dose of Kindolor in healthy volunteers?
* How is Kindolor metabolized by the human body?
Participants will undergo medical tests before and after receiving Kindolor or a placebo to see if there is any difference between the groups.
Detailed Description:
Eligible participants will undergo intake procedures and baseline evaluations at the clinic the day before dosing. The next day, participants will be randomized to, and receive, either Kindolor tablets or placebo tablets (4 cohorts of escalating doses of Kindolor with 6 Kindolor participants and 2 placebo participants in each cohort). Participants will remain in the clinic for at least an additional 48-hours for safety assessments and blood collections to determine plasma levels of Kindolor, then will be discharged from the clinic and return for follow-up safety tests 7 days later.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UH3DA047680 | NIH | None | https://reporter.nih.gov/quic… | View |