None listed
Conditions
Brief summary
Beren Therapeutics is evaluating the therapeutic potential of BRN-002 when administered intravenously. The purpose of this study is to evaluate the safety and tolerability of BRN-002 administered intravenously every 14 days, as well as to gain an understanding of the repeat dose pharmacokinetics (PK) profile and pharmacodynamics (PD) of BRN-002. The total study duration will be of up to 13 weeks including the screening, intervention and follow-up period. The intervention duration will be of 7 weeks (4 dose total). Participants will be confined to the clinic starting the evening prior to each dose through 2 days after each dose. Participants will fast for 8 hours prior to each dose. They will be discharged from the clinic once all scheduled PK and safety assessments have been collected. Participants will also undergo audiometry testing prior to discharge.
Interventions
The study consists of three active treatment arms and one placebo arm.
Participants will receive BRN-002 or Placebo once every 14 days over 7 weeks for a total of 4 doses intravenously.
Arm 1- BRN-002 500 mg/kg IV
Arm 2- BRN-002 1000 mg/kg IV
Arm 3- BRN-002 1500 mg/kg IV
Arm 4- Placebo 0 mg/kg IV
Study drugs will be administered under the supervision of study personnel and treatment compliance will be verified according to the site's SOP (Standard Operating Procedures). The date and time of eac
The study consists of three active treatment arms and one placebo arm. Participants will receive BRN-002 or Placebo once every 14 days over 7 weeks for a total of 4 doses intravenously. Arm 1- BRN-002 500 mg/kg IV Arm 2- BRN-002 1000 mg/kg IV Arm 3- BRN-002 1500 mg/kg IV Arm 4- Placebo 0 mg/kg IV Study drugs will be administered under the supervision of study personnel and treatment compliance will be verified according to the site's SOP (Standard Operating Procedures). The date and time of each dose administered in the clinic will be recorded in the source documents.
Sponsors
Beren Therapeutics, PBC
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female participant between 18 to 65 years of age (both inclusive) 2. Body Mass Index (BMI) within the range 18.5 to 35 kg/m2 (inclusive) at screening 3. Healthy participants who have clinical laboratory parameters within normal range 4. Participants with normal audiogram at screening 5. Normal ECG at screening
Exclusion criteria
1. Prior history of hearing abnormalities, inner ear disorders, frequent ear infections or vestibular disturbance 2. Non-insulin or insulin-dependent diabetes mellitus (documented or on HbA1c analysis with HbA1c more than 6.5%) 3. Documented inflammatory disease 4. Infectious disease 5. Lymphoma, leukemia or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of active disease and low or no risk of recurrence 6. Cognitive, psychological, or addictive conditions that in opinion of the investigator may interfere with participant compliance 7. Acute illness, hospital admission or major surgery within 30 days prior to dosing 8. Use of any prescription medication within 14 days or 5 half-lives prior to dosing 9. Use of or intended use of prohibited over the counter medications or natural health products within 7 days prior to dosing or intended use during study 10. Received any vaccination within 14 days prior to dosing 11. Current enrollment or past participation in another investigational study within 30 days of screening 12.Low-density lipoprotein cholesterol more than 190 mg/dL 13.QtcF more than 450 msec for male or more than 470 msec for female participants a PR interval outside the range 120 to 220 msec. 14. Positive human immunodeficiency virus (HIV) antibody test or positive hepatitis B surface antigen or hepatitis C antibody test at screening 15. Positive COVID-19 test at screening
Outcome results
None listed