NCT04146805

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Blade Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Liver Disease
• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	BLD-0409	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).
DRUG	Control: Placebo	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).

Timeline

• Start date: 2020-01-10
• Primary completion: 2020-12-03
• Completion: 2021-04-12
• First posted: 2019-10-31
• Last updated: 2021-06-04

Locations

1 site across 1 country: Australia