Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-02-21 @ 8:56 PM
Study NCT ID:
NCT04146805
Status:
COMPLETED
Last Update Posted:
2021-06-04
First Post:
2019-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Subjects
Sponsor:
Blade Therapeutics
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: