Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Subjects
- Conditions
- Chronic Liver DiseaseNASH - Nonalcoholic Steatohepatitis
- Interventions
- Registration Number
- NCT04146805
- Lead Sponsor
- Blade Therapeutics
- Brief Summary
A Phase 1a, Double Blind, Placebo-Controlled, Single-Center, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Volunteers
- Detailed Description
The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of BLD-0409 in healthy volunteers (HV) to facilitate the dose/dosing regimen selection for future clinical studies with BLD-0409 in various chronic liver diseases.
The study consists of two parts:
Part 1: SAD in HV with up to 6 cohorts (including a food effect cohort). For SAD cohorts and planned dosing schedule.
Part 2: MAD over 14 days with up to 6 cohorts. For MAD cohorts and planned dosing schedule.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1SAD/Part 2 MAD:Active Treatment(BLD-0409) BLD-0409 For each cohort in both study parts, 6 subjects will be randomized to active (BLD-0409). Study drug will be administered orally once a day, with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s)
- Primary Outcome Measures
Name Time Method Number of treatment subjects with treatment-related changes in heart rate up to 56 days Assessed by collecting and evaluating any observed changes in heart rate. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in hematology clinical laboratory test results. up to 56 days Assessed by collecting and analyzing subjects' blood from baseline by dose. Results in subjects dosed with BLD-0409 treatment will be compared to those dosed with placebo.
Number of treatment subjects with treatment-related changes in systolic & diastolic blood pressure up to 56 days Assessed by collecting and evaluating any observed changes in systolic \& diastolic blod pressure. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in ECG tracings up to 56 days Assessed by performing 12-lead ECGs, and evaluating ECG tracings from baseline, by dose. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Incidence of Adverse Events (AEs) up to 56 days AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Number of treatment subjects with treatment-related changes in body temperature up to 56 days Assessed by collecting body temperature using a thermometer. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in urinalysis clinical laboratory test results. up to 56 days Assessed by collecting and analyzing subjects' urine from baseline by dose. Results in subjects dosed with BLD-0409 treatment will be compared to those dosed with placebo.
Number of subjects with treatment-related subjects changes in physical examinations up to 56 days Assessed by performing physical examinations include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes, from baseline by dose, through out the study.
Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.Number of subjects with treatment-related changes in QTc intervals up to 56 days Assessed by performing 12-lead ECGs, and evaluating QTc intervals from baseline, by dose. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in chemistry clinical laboratory test results. up to 56 days Assessed by collecting and analyzing subjects' blood from baseline by dose. Results in subjects dosed with BLD-0409 treatment will be compared to those dosed with placebo.
Number of subjects with treatment-related changes in serology clinical laboratory test results. up to 56 days Assessed by collecting and analyzing subjects' blood from baseline by dose. Results in subjects dosed with BLD-0409 treatment will be compared to those dosed with placebo.
- Secondary Outcome Measures
Name Time Method Area under the drug concentration-time curve from time zero to the last measurable concentration (AUClast) up to 56 days To characterize the Plasma pharmacokinetics(PK) of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo
Area under the drug concentration time curve from time 0 to infinity (AUC0-inf) up to 56 days To characterize the Plasma PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Time of the maximum drug concentration (tmax) up to 56 days To characterize the Plasma PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Apparent terminal elimination rate constant (kel) up to 56 days To characterize the Plasma PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Apparent elimination half life (t½) up to 56 days To characterize the Plasma PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Any observed Changes in serum Lysophosphatidic Acid Receptor (LPA) C18:2 up to 56 days Measured by serum in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Apparent oral clearance up to 56 days To characterize the Plasma PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Apparent terminal volume of distribution up to 56 days To characterize the Plasma PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Amount excreted during each collection interval (Ae(t'-t'')) up to 56 days To characterize the urine PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Total amount of drug excreted unchanged in the urine over the entire period of sample collection up to 56 days To characterize the urine PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Percentage of dose excreted unchanged during each collection interval (Fe(t' t")) and over the entire period of sample collection up to 56 days To characterize the urine PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Maximum observed drug concentration (Cmax) up to 56 days To characterize the Plasma PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Renal clearance (CLr) for each collection interval and over the entire period of sample collection up to 56 days To characterize the urine PK of BLD-0409 in healthy volunteers. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Trial Locations
- Locations (1)
Scientia Clinical Research
🇦🇺Randwick, New South Wales, Australia