NL-OMON53497
Completed
Not Applicable
A phase 1b study to evaluate the pharmacokinetics and safety of CLE-600 in patients with Parkinson*s disease - CLE-600 PK and safety study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Clexio Biosciences Ltd
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Sex : male or female; females must be of nonchildbearing potential or
- •postmenopausal.
- •2\. Age : 40 to 80 years, inclusive, at screening.
- •3\. Body mass index (BMI) : 18\.0 to 32\.0 kg/m2, inclusive, at screening.
- •4\. Weight : \>\=50 kg, at screening.
- •5\. Status : PD patients (diagnosed according to UK PD Society Brain Bank
- •Further criteria apply
Exclusion Criteria
- •1\. Previous participation in the current study.
- •2\. Employee of ICON or the Sponsor.
- •3\. History of alcohol abuse or drug addiction within the last year (including
- •soft drugs like cannabis products), except for tobacco use disorder.
- •4\. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
- •\[including ecstasy], cannabinoids, barbiturates, benzodiazepines, and alcohol)
- •at screening or admission (Day 1 for Part A and Day \-1 for Part B) to the
- •clinical research center. For cannabinoids, in case of a positive screen the
- •Investigator should decide whether this is related to medical or recreational
- •use (then subject may be included) or to drug addiction (then subject should be
Outcomes
Primary Outcomes
Not specified
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