A Study to Evaluate BW-00112 in Adult Subjects

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-00112 in Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622001429741

Enrollment

Registered

2022-11-08

Start date

2023-01-31

Completion date

2023-06-02

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a randomized, double-blind, placebo-controlled, single ascending dose study of BW-00112 when administered subcutaneously to subjects. Approximately 32 male and female subjects with elevated Low-density lipoprotein cholesterol , aged 18 to 65 years who fulfill the inclusion and exclusion criteria will be enrolled at 2 to 3 sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 (24 hours post-dose) after completing the 24-hour post-dose follow-up assessments, and return for outpatient visits through Day 85. There will be 4 separate and sequential dose cohorts. The population in Cohorts 1 to 4 (50mg, 150mg, 300mg and 600mg) will include subjects with fasting Low-density lipoprotein cholesterol levels > = 100 mg/dL and 100 mg/dL < = Triglycerides (fasting) < 500 mg/dL who are not on a lipid-lowering therapy.

Interventions

Treatment: Drugs - BW-00112 4 Cohorts: 50mg, 150mg, 300mg and 600mg The duration of administration: single dose BW-00112 will be administered via subcutaneous injection by registered nurse The used and/or partially used vials can be disposed of per local practice. If the used and/or partially used vials cannot be disposed of at site, they will be returned, along with the unused vials, to the sponsor or its agent after receipt of written authorization from Sponsor.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. All subjects are required to have elevated fasting Low-density lipoprotein cholesterol > = 100 mg/dL [2.69 mmol/L] and 100 mg/dL [1.13 mmol/L] < = Triglycerides (fasting) < 500 mg/dL [5.65 mmol/L] and have not been treated with lipid-lowering medicines in the past 3 month. 2. On a usual diet for at least 4 weeks prior to screening with no plans to significantly alter diet or weight over course of study.

Exclusion criteria

1. Any uncontrolled or serious disease or clinically significant abnormality in laboratory parameters which in the judgment of the Investigator might compromise the safety of the subject or integrity of the study, interfere with the subject participation in the trial or compromise the trial objectives. 2. Any liver function panel analyte value > 1.5 x upper limits of normal reference range which includes Aspartate transaminase, Alanine transaminase, Total Bilirubin (for subjects with Gilbert’s Syndrome, total bilirubin < = 3.0 × upper limits of normal is allowed if direct bilirubin < = 50%), Alkaline Phosphatase, and gamma-glutamyl transferase at Screening. 3. International normalized ratio above 1.2 x upper limits of normal reference range reference range (as per the local laboratory reference range) at screening. 4. Calculated creatinine clearance < = 60 mL/min (Cockcroft-Gault equation). 5. History or presence of cardiovascular disease. 6. History or presence of Type 1 or type 2 diabetes mellitus at screening.

Outcome results