Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593730
Status:
COMPLETED
Last Update Posted:
None
First Post:
2015-06-09
Brief Title:
Safety and Tolerability of the Twice Daily Intra-anal Application of NRL001 Cream for 14 Days
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Double-blind Placebo-controlled Randomised Parallel-group Study in Healthy Volunteers to Evaluate the Safety Tolerability Pharmacodynamic Effects and Pharmacokinetics of Twice Daily Intra-anal Application of NRL001-cream for 14 Days
Status:
COMPLETED
Status Verified Date:
2024-09
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:
The study is being conducted to evaluate the safety and tolerability after single and repeated twice daily intra-anal applications of 1mL NRL001 cream in stepwise increasing concentrations
Detailed Description:
Single-centre randomised placebo-controlled double-blind repeated dose study in healthy male and female volunteers comprising up to six sequential dose groups receiving 1 mL doses of an investigational cream formulation containing 050 075 100 150 200 and 250 ww NRL001 Doses were to be investigated in stepwise increasing fashion Progression to a higher dose-step required completion of the previous dose-step without safety limiting findings Each dose-step was to be investigated in 12 subjects in each dose-group subjects assigned to active treatment were to be studied in parallel with subjects assigned to placebo in double-blind fashion with random 93 treatment assignment Each subject was to be studied for one study period with double-blind investigational treatment 1 mL of an investigational cream formulation containing NRL001 or matched placebo twice daily from the morning of D01 to the afternoon of D14 this phase was to be preceded by a single-blind placebo control day D-1 with administration of placebo in the morning and afternoon
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