A phase 1, randomized, double-blind, placebo-controlled, safety, tolerability, pharmacokinetic and biomarker study of multiple ascending doses of ESB1609 in healthy volunteers.
- Conditions
- Niemann-Pick C disease (NPC)1002766410013317
- Registration Number
- NL-OMON55239
- Lead Sponsor
- ESCAPE Bio, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Part 1 Subject Inclusion Criteria
1. The subject has provided written informed consent.
2. The subject is a male 18 to 55 years of age (inclusive at screening)
3. For Cohort 3 B only the subject is a male aged 55-65 years of age
Part 1 Subject Exclusion Criteria
1. The subject has a current or recurrent disease (e.g., cardiovascular, renal,
liver, gastrointestinal, malignancy or other conditions) that could affect the
action, absorption or disposition of the investigational product or could
affect clinical or laboratory assessments.
2. The subject has a clinically significant 12-lead ECG abnormality, including
QTc of >450 msec (average of triplicate measures via Fridericia*s corrections)
for any Screening or Day -1 ECG assessment.
3. The subject has a history of clinically significant bradycardia syndromes
(e.g., sick sinus syndrome) or sinus bradycardia at Screening or Day -1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method