OLP-1002 is Being Studied in the Treatment of Pain.
NCT03760913 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2021-08-26
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
OliPass Corporation
lead INDUSTRY
Principal Investigators
-
Firas Almazedi, MBChB, MSc, CPI, DipPharmMed · Covance CRU Leeds
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-11-21
- Primary Completion
- 2020-10-16
- Completion
- 2020-10-16
Countries
- United Kingdom
Study Locations
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