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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Subjects

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

NCT04146805•Blade Therapeutics

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects are eligible to be included in the study only if all the following criteria apply:
•Age and Gender
•1. Male and female subjects 18-55 years of age (inclusive) at the time of signing the PICF.
•Diagnosis and disease characteristics
•2. 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.
•3. 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.
•4. 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.
•5. 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.
•6. 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.
•7. 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.
+2 more criteria

Exclusion Criteria

•Medical Conditions
•1. Recent (less than 6 weeks) wound, or presence of an ongoing non-healing skin wound.
•2. 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.
•3. 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.
•4. Serious local or systemic infection within 1 month of Screening requiring antibiotic treatment or history of recurrent infections.
•5. Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant.
•Diagnostic Assessments
•6. Positive for human immunodeficiency virus (HIV) antibody or antigen.
•7. Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
•8. 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.
+31 more criteria

Locations (1)

Scientia Clinical Research

Randwick, New South Wales, Australia

Key Dates

Start Date

January 10, 2020

Primary Completion Date

December 3, 2020

Completion Date

April 12, 2021

Last Updated

June 4, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Liver DiseaseNASH - Nonalcoholic Steatohepatitis

Interventions

BLD-0409

DRUG

Control: Placebo

DRUG

Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry

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Chronic Liver Disease and ACLF

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RECRUITING

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Advanced Chronic Liver Disease

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RECRUITINGPHASE4

Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry

LSM and SSM for the Diagnosis of CSPH: a Prospective Cohort Study

Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

Albumin Modifications as Early Biomarkers of Chronic Liver Diseases

Non-invasive Methods for Predicting Decompensation of Chronic Liver Disease