Study in Healthy Volunteers to Document Safety and Tolerability of Increasing Doses Pemirolast
NCT02517372 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2015-08-07
Summary
This study is a single-centre, open-label, dose escalation , safety, tolerability and pharmacokinetics (PK) study in healthy male and female subjects. The study include a screening day and a 5-day dosing period. Subjects will be enrolled in sequential cohorts and each cohort will include 8 subjects. there will be 24 subjects total included in the study. The duration of the clinical part of the study will be approximately 2 months.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
CRD007
Sponsors & Collaborators
-
RSPR Pharma AB
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2014-12-31
- Completion
- 2014-12-31
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