CompletedPhase 1ACTRN12621001479897

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

A Phase 1, Open label, Single Ascending Dose Study of Intravenous and Oral Doses of BRN-002 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects

Sponsor

Beren Therapeutics, PBC

Enrollment

30 participants

Start Date

Nov 8, 2021

Study Type

Interventional

Conditions

Atherosclerosis

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, as well as to gain an understanding of the pharmacokinetics (PK), and oral bioavailability, of BRN-002 and how that correlates with potential pharmacodynamic (PD) changes. There will be 5 cohorts of 6 healthy participants in the study. Each participant will receive a single IV dose of BRN-002 administered as an infusion. Cohort 2 will also receive a single equivalent oral dose of BRN-002 to evaluate oral bioavailability, one week after IV dosing. Participants will be enrolled into cohorts sequentially. A Cohort Review Committee will evaluate the safety of each participant and the combined cohorts prior to dose escalation. Following screening, eligible participants will be admitted to the Phase 1 clinic on Day -1, receive a single IV infusion of BRN-002 on Day 1 and remain in the clinic until Day 3 then discharged approximately 48 hours post-dose after all scheduled PK and safety assessments have been collected. Eligible participants in Cohort 2 will be re-admitted to the Phase 1 clinic on Day 21 and receive an equivalent oral dose of BRN-002 on Day 22; the same PK and safety assessments will be collected and they will be discharged by the end of Day 24.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria4

Healthy subjects aged 18 to 65 years old, both inclusive
Normal audiogram at screening
Normal ECG at screening
Body mass index between 18.5 to 35

Exclusion Criteria19

Prior history of hearing abnormalities, inner ear disorders, frequent ear infections or
vestibular disturbance, i.e., Meniere’s disease,
Non-insulin or insulin-dependent diabetes mellitus (documented or on HbAc1 analysis
with HbA1C >6.5%)
Documented inflammatory disease (e.g., including but not limited to auto immune
disorder, chronic obstructive pulmonary disorder, inflammatory bowel disease, arthritis)
Known or diagnosed malignancies in the past 5 years
Infectious disease (documented or on lab analysis [hepatitis B and hepatitis C virus
[HBV/HCV], human immunodeficiency virus [HIV], Coronavirus disease 2019
[COVID-19])
Received a vaccination within 14 days prior to dosing
Acute illness within 30 days prior to dosing
Hospital admission or major surgery within 30 days prior to dosing
Use of prescription medications within 2 weeks/5 half-lives of dosing, whichever is
longer
Low-density lipoprotein cholesterol >130 mg/dL
Women who are pregnant, breast-feeding, or of child-bearing potential
History of cigarette smoking or nicotine vaping within the past year prior to screening
Vital sign parameters outside of the normal range

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Interventions

This is a Phase 1A, open label, single ascending dose (SAD) study to evaluate the safety, PK (including oral bioavailability) and PD of intravenous (IV) and oral doses of BRN-002 in healthy subjects.

This is a Phase 1A, open label, single ascending dose (SAD) study to evaluate the safety, PK (including oral bioavailability) and PD of intravenous (IV) and oral doses of BRN-002 in healthy subjects. There will be 5 Cohorts of 6 healthy subjects. Each subject will receive a single IV dose of BRN-002. Cohort 2 will also receive a single equivalent oral dose of BRN-002 to evaluate oral bioavailability, one week after IV dosing. Subjects will be enrolled into Cohorts sequentially, with the exception of Cohort 1 & 2, that will be dosed simultaneously. Investigational Product: BRN-002 Subjects will receive a single IV dose of 50, 250, 500, 1000 or 1500 mg/kg of BRN-002 administered as an infusion over 2 hours; subjects in Cohort 2 will also receive an equivalent oral dose of 250 mg/kg as an oral solution. A Cohort Review Committee will evaluate the safety of each subject and the combined Cohorts prior to dose escalation in Cohorts 3, 4, and 5. Cohort 1 and Cohort 2 will be dosed simultaneously. The study duration will be up to 42 days for an individual subjects in Cohorts 1, 3, 4, and 5 and up to 60 days for an individual subject in cohort 2. The treatment duration will be a single dose for Cohorts 1, 3, 4, and 5 and two single dose administrations for subjects in Cohort 2.