Chronic Liver DiseasePhase 1NCT04146805
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Subjects
A Phase 1 study testing BLD-0409 in people with Chronic Liver Disease and NASH - Nonalcoholic Steatohepatitis, run by Blade Therapeutics at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Liver Disease, NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- BLD-0409
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Jan 2020to 12 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects are eligible to be included in the study only if all the following criteria apply:
- Age and Gender
- Male and female subjects 18-55 years of age (inclusive) at the time of signing the PICF.
- Diagnosis and disease characteristics
- Subjects must be in good general health, in the opinion of the Investigator, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, and/or before administration of the initial dose of study drug.
- Subjects must have clinical laboratory values within normal ranges or < 1.2 times upper limit of normal (ULN) as specified by the testing laboratory, unless deemed not clinically significant (NCS) by the Investigator, with exception of liver function tests which cannot be above the ULN.
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- Body mass index (BMI) 18 to ≤ 32 kg/m2. Reproductive Considerations Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. For details refer to Appendix 4.
- Female subjects and female partners of male subjects must use double barrier contraception and refrain from oocyte donation from first dose of study drug and for 60 days after last dose of study drug. Estrogen-containing products are not allowed.
- Male subjects must agree to use highly effective, double barrier contraception and refrain from sperm donation from first dose of study drug and for 90 days after last dose of study drug.
- Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. Females not of childbearing potential must be surgically infertile or post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle-stimulating hormone (FSH) level > 40 mIU/mL at Screening.
- Informed Consent
- Subjects must provide signed informed consent prior to study entry and have the ability and willingness to attend and comply with the necessary visits at the study site.
Who cannot join
- Subjects meeting ANY of the following exclusion criteria are NOT eligible to be randomized into the study:
- Medical Conditions
- Recent (less than 6 weeks) wound, or presence of an ongoing non-healing skin wound.
- Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol.
- Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low grade cervical intraepithelial neoplasia.
- Serious local or systemic infection within 1 month of Screening requiring antibiotic treatment or history of recurrent infections.
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- Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant.
- Diagnostic Assessments
- Positive for human immunodeficiency virus (HIV) antibody or antigen.
- Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
- Systolic blood pressure (BP) > 150 mmHg or < 90 mmHg or diastolic BP > 90 mmHg or < 50 mmHg at Screening with one repeat allowed per the Investigator's discretion at Screening and Day -1.
- Heart rate < 40 beats per minute (bpm) or > 100 bpm at Screening.
- Prolonged QTcF (>450 ms for males and >470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting ECG, as judged by the Investigator.
- Females with heavy menstruating cycles and borderline-low iron studies. Prior Therapy
- All prescription and over the counter medications (including herbal medications), except for non-estrogen contraceptives, are prohibited within 7 days prior to the first study drug administration and throughout the entire duration of the study.
- Any estrogen-containing products, e.g., contraceptives, patch, cream, implants within 14 days prior to the first study drug administration.
- Prior/Concurrent Clinical Study Experience
- Administration of investigational product in another study within 30 days prior to the first study drug administration, or five half-lives, whichever is longer.
- Other Exclusions
- Significant weight loss or gain between Screening and first study drug administration.
- Blood donation or significant blood loss within 60 days prior to the first study drug administration.
- Plasma donation within 7 days prior to the first study drug administration.
- Females who are pregnant or breastfeeding.
- Diets that could alter metabolism (i.e., high protein, Slim Fast®, Nutrisystem®, etc.) within 7 days prior first study drug administration.
- History or presence of alcohol or drug abuse (including recreational marijuana use) within the 1 year prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period.
- Positive urine drug screen/alcohol breath test at Day -1 (admission). Repeat urine drug screens will be permitted for suspected false positive results.
- Intake of alcohol or caffeine-containing products from 48 hours before first study drug administration.
- Active smokers and users of nicotine-containing products.
- Failure to satisfy the Investigator of fitness to participate for any other reason.
- Lifestyle Considerations Meals and Dietary Restrictions
- Subjects will fast from all food and drink except water for ≥ 10 hours before morning study drug administration on Day 1.
- Except during the periods of fasting, standard meals and snacks will be provided at the discretion of the Investigator while subjects are confined in the study site.
- For food effect Cohort 1e:
- On Day 8, subjects will be provided a standard high calorie breakfast from 30 minutes before dose administration (and to be consumed entirely within that 30 minutes). The meal is to follow United States Food and Drug Administration (FDA) guidance regarding caloric content and composition. The test meal should derive approximately 150, 250 and 500 600 calories from protein, carbohydrate, and fat, respectively. An example test meal would be two eggs fried in butter, two strips of bacon, and two slices of toast with butter, four ounces of hash brown potatoes and eight ounces of whole milk. Substitutions in this test meal can be made as long as the meal provided a similar amount of calories from protein, carbohydrate and fat and has comparable meal volume and viscosity. Vegetarians may be enrolled provided that there is a consultation with a dietician regarding comparable calories, volume and viscosity.
- Water restrictions may be needed. No water is allowed 1 hour before and after dosing, after which time, water is allowed ad libitum.
- Subjects will refrain from consumption of Seville oranges, grapefruit or grapefruit juice, from 48 hours before the start of study drug until after the final PK sample is obtained.
- Subjects will refrain from diets that could alter metabolism (i.e., high protein, Slim Fast®, Nutrisystem®, etc.) within 7 days prior to dosing on Day 1.
- Caffeine, Alcohol, and Tobacco
- During each dosing session, subjects will abstain from ingesting caffeine- or xanthine-containing products (e.g., coffee, tea, cola drinks, and chocolate) for 48 hours before the start of dosing until after collection of the final pharmacokinetic (PK) and/or pharmacodynamic sample.
- During each dosing session, subjects will abstain from alcohol for 48 hours before the start of dosing until EOS visit.
- Active smokers and users of nicotine-containing products will be excluded from the study.
- Other Restrictions Subjects will avoid strenuous physical activity (e.g. weightlifting, running, bicycling) from 24 hours prior to Day 1 until discharge from the study site and for 24 hours prior to the EOS visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the 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.
- Being tested
- BLD-0409, Control: Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLD-0409Drug
For each cohort in both study parts, 8 subjects will be randomized in a 6:2 ratio to active (BLD-0409) : control (matched placebo). Study drug will be administered orally once a day, with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s).
Control: PlaceboDrug
Subjects will be randomized in a 6:2 ratio to control (matched placebo). Study drug will be administered orally once a with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s).
| Study group | Role | What they receive |
|---|---|---|
| Part 1SAD/Part 2 MAD:Active Treatment(BLD-0409) | Experimental | 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) Receives: Drug: BLD-0409 |
| Part 1SAD/Part 2 MAD:Control(Matched Placebo) | Placebo comparator | For each cohort in both study parts, 2 subjects will be randomized to control (matched placebo). Study drug will be administered orally once a day, with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s). Receives: Drug: Control: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Measured: up to 56 days
Number of subjects with treatment-related subjects changes in physical examinations
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.
Measured: up to 56 days
Number of treatment subjects with treatment-related changes in heart rate
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.
Measured: up to 56 days
Number of treatment subjects with treatment-related changes in systolic & diastolic blood pressure
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.
Measured: up to 56 days
Number of treatment subjects with treatment-related changes in body temperature
Assessed by collecting body temperature using a thermometer. Results in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Measured: up to 56 days
Number of subjects with treatment-related changes in ECG tracings
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.
Measured: up to 56 days
Number of subjects with treatment-related changes in QTc intervals
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.
Measured: up to 56 days
Number of subjects with treatment-related changes in hematology clinical laboratory test results.
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.
Measured: up to 56 days
Number of subjects with treatment-related changes in chemistry clinical laboratory test results.
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.
Measured: up to 56 days
Number of subjects with treatment-related changes in urinalysis clinical laboratory test results.
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.
Measured: up to 56 days
Number of subjects with treatment-related changes in serology clinical laboratory test results.
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.
Measured: up to 56 days
Secondary outcomes (13)
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUClast)
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
Measured: up to 56 days
Area under the drug concentration time curve from time 0 to infinity (AUC0-inf)
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.
Measured: up to 56 days
Maximum observed drug concentration (Cmax)
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.
Measured: up to 56 days
Time of the maximum drug concentration (tmax)
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.
Measured: up to 56 days
Apparent terminal elimination rate constant (kel)
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.
Measured: up to 56 days
Apparent elimination half life (t½)
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.
Measured: up to 56 days
Apparent oral clearance
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.
Measured: up to 56 days
Apparent terminal volume of distribution
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.
Measured: up to 56 days
Amount excreted during each collection interval (Ae(t'-t''))
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.
Measured: up to 56 days
Total amount of drug excreted unchanged in the urine over the entire period of sample collection
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.
Measured: up to 56 days
Percentage of dose excreted unchanged during each collection interval (Fe(t' t")) and over the entire period of sample collection
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.
Measured: up to 56 days
Renal clearance (CLr) for each collection interval and over the entire period of sample collection
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.
Measured: up to 56 days
Any observed Changes in serum Lysophosphatidic Acid Receptor (LPA) C18:2
Measured by serum in subjects dosed with BLD-0409 will be compared to those dosed with placebo.
Measured: up to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start10 Jan 2020
- Primary completion3 Dec 2020
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blade Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146805
- Sponsor's protocol ID
- B-0409-101
- Status last verified
- Feb 2021
- First submitted
- 23 Oct 2019
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04146805
- Acronym / sponsor ID
- B-0409-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Blade TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1SAD/Part 2 MAD:Active Treatment(BLD-0409) | Experimental | Drug: BLD-0409For 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) |
| Part 1SAD/Part 2 MAD:Control(Matched Placebo) | Placebo comparator | Drug: Control: PlaceboFor each cohort in both study parts, 2 subjects will be randomized to control (matched placebo). Study drug will be administered orally once a day, with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subjects are eligible to be included in the study only if all the following criteria apply:
- Age and Gender
- Male and female subjects 18-55 years of age (inclusive) at the time of signing the PICF.
- Diagnosis and disease characteristics
- Subjects must be in good general health, in the opinion of the Investigator, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, and/or before administration of the initial dose of study drug.
Key exclusion criteria (42 listed)
- Subjects meeting ANY of the following exclusion criteria are NOT eligible to be randomized into the study:
- Medical Conditions
- Recent (less than 6 weeks) wound, or presence of an ongoing non-healing skin wound.
- Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol.
- Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low grade cervical intraepithelial neoplasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLD-0409For each cohort in both study parts, 8 subjects will be randomized in a 6:2 ratio to active (BLD-0409) : control (matched placebo). Study drug will be administered orally once a day, with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s). | Drug | Part 1SAD/Part 2 MAD:Active Treatment(BLD-0409) |
| Control: PlaceboSubjects will be randomized in a 6:2 ratio to control (matched placebo). Study drug will be administered orally once a with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s). | Drug | Part 1SAD/Part 2 MAD:Control(Matched Placebo) |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: up to 56 days
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Number of subjects with treatment-related subjects changes in physical examinations
Time frame: 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 treatment subjects with treatment-related changes in heart rate
Time frame: 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 treatment subjects with treatment-related changes in systolic & diastolic blood pressure
Time frame: 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 treatment subjects with treatment-related changes in body temperature
Time frame: 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 ECG tracings
Time frame: 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.
Number of subjects with treatment-related changes in QTc intervals
Time frame: 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 hematology clinical laboratory test results.
Time frame: 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 chemistry clinical laboratory test results.
Time frame: 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 urinalysis clinical laboratory test results.
Time frame: 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 changes in serology clinical laboratory test results.
Time frame: 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.
13 secondary outcomes
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUClast)
Time frame: up to 56 days
Area under the drug concentration time curve from time 0 to infinity (AUC0-inf)
Time frame: up to 56 days
Maximum observed drug concentration (Cmax)
Time frame: up to 56 days
Time of the maximum drug concentration (tmax)
Time frame: up to 56 days
Apparent terminal elimination rate constant (kel)
Time frame: up to 56 days
Apparent elimination half life (t½)
Time frame: up to 56 days
Apparent oral clearance
Time frame: up to 56 days
Apparent terminal volume of distribution
Time frame: up to 56 days
Amount excreted during each collection interval (Ae(t'-t''))
Time frame: up to 56 days
Total amount of drug excreted unchanged in the urine over the entire period of sample collection
Time frame: up to 56 days
Percentage of dose excreted unchanged during each collection interval (Fe(t' t")) and over the entire period of sample collection
Time frame: up to 56 days
Renal clearance (CLr) for each collection interval and over the entire period of sample collection
Time frame: up to 56 days
Any observed Changes in serum Lysophosphatidic Acid Receptor (LPA) C18:2
Time frame: up to 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BLD-0409 in people with Chronic Liver Disease and NASH - Nonalcoholic Steatohepatitis, run by Blade Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: up to 56 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.