CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 116 enrolled
Drug / intervention
OLP-1002 (Test): Part A, Single Ascending Dose +3 moredrug
Likely dose
OLP-1002 (Test): Part A, Single Ascending Dose 1.2 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03760913
NCT03760913Early Ph 1Completed

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

OliPass Corporation·interventional·Posted Dec 3, 2018·Updated Aug 26, 2021

In Brief

A Early Phase 1 clinical trial evaluating OLP-1002 (Test): Part A, Single Ascending Dose, OLP-1002 (Test): Part B, Multiple Ascending Dose, and 2 other interventions for Pain. Completed, enrolled 116 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited Kingdom
Collaborators--

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedDec 3, 2018
Enrollment StartNov 21, 2018
Primary CompletionOct 16, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.6 years ago

Interventions

OLP-1002 (Test): Part A, Single Ascending Dosedrug

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

OLP-1002 (Test): Part B, Multiple Ascending Dosedrug

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

Placebo: Placebo Part A, Single Ascending Doseother

Subcutaneous Injection: Placebo

Placebo: Placebo Part B, Multiple Ascending Doseother

Subcutaneous Injection: Placebo x 5