NCT03760913

OLP-1002 is Being Studied in the Treatment of Pain.

OLP-1002 - A First-in-human, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: OliPass Corporation · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to assess the safety and tolerability of single and multiple subcutaneous doses of OLP-1002 in healthy subjects.

Detailed description

The exploratory objectives of the study are to evaluate the pharmacodynamic effect of OLP-1002 following single subcutaneous doses in healthy volunteers using a capsaicin pain model, and to monitor the effects of a single subcutaneous doses of OLP-1002 on cardiac QT interval. Where possible, single and/or multiple subcutaneous dose pharmacokinetics of OLP-1002 in healthy subjects will be determined.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	OLP-1002 (Test): Part A, Single Ascending Dose	Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 µg, 3 µg, 6 µg, 12 µg, 20 µg, 40 μg, 80 μg, 160 μg
DRUG	OLP-1002 (Test): Part B, Multiple Ascending Dose	Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg
OTHER	Placebo: Placebo Part A, Single Ascending Dose	Subcutaneous Injection: Placebo
OTHER	Placebo: Placebo Part B, Multiple Ascending Dose	Subcutaneous Injection: Placebo x 5

Timeline

• Start date: 2018-11-21
• Primary completion: 2020-10-16
• Completion: 2020-10-16
• First posted: 2018-12-03
• Last updated: 2021-08-26
• Results posted: 2021-08-26

Locations

1 site across 1 country: United Kingdom