An Open label, Single Ascending Dose Study of Intravenous and Oral Doses of BRN-002 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Participants
- Conditions
- AtherosclerosisCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12621001479897
- Lead Sponsor
- Beren Therapeutics, PBC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 29
1. Healthy subjects aged 18 to 65 years old, both inclusive
2. Normal audiogram at screening
3. Normal ECG at screening
4. Body mass index between 18.5 to 35
1. Prior history of hearing abnormalities, inner ear disorders, frequent ear infections or
vestibular disturbance, i.e., Meniere’s disease,
2. Non-insulin or insulin-dependent diabetes mellitus (documented or on HbAc1 analysis
with HbA1C >6.5%)
3. Documented inflammatory disease (e.g., including but not limited to auto immune
disorder, chronic obstructive pulmonary disorder, inflammatory bowel disease, arthritis)
4. Known or diagnosed malignancies in the past 5 years
5. Infectious disease (documented or on lab analysis [hepatitis B and hepatitis C virus
[HBV/HCV], human immunodeficiency virus [HIV], Coronavirus disease 2019
[COVID-19])
6. Received a vaccination within 14 days prior to dosing
7. Acute illness within 30 days prior to dosing
8. Hospital admission or major surgery within 30 days prior to dosing
9. Use of prescription medications within 2 weeks/5 half-lives of dosing, whichever is
longer
10. Low-density lipoprotein cholesterol >130 mg/dL
11. Women who are pregnant, breast-feeding, or of child-bearing potential
12. History of cigarette smoking or nicotine vaping within the past year prior to screening
13. Vital sign parameters outside of the normal range
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method