Healthy Volunteer Study Comparing Tablet and Capsule Formulations

A Two-Part, Open Label, Complete Crossover Study to Compare the Tablet and Capsule Formulations of BLD-2660, Including a Food Effect Assessment of the Tablet Formulation, and to Assess Dose Proportionality Following Single Oral Doses of BLD-2660 in Tablet Formulation

Single center, randomized, open label, two-part crossover study designed to evaluate the PK, food effect, dose proportionality, safety, and tolerability of BLD-2660 in healthy volunteers.

Study Overview

• Status: Withdrawn
• Conditions: Fibrosis
• Intervention / Treatment: Drug: BLD-2660

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Scientia Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to provide written informed consent
• Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
• Normal BMI (18 to ≤ 35 kg/m2)
• Have a negative urine drug screen/alcohol breath test on admission to clinic
• Agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 90 days following completion of dosing
• Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test on Day -1
• Be in general good health
• Clinical laboratory values within normal range

Exclusion Criteria:

• Recent 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
• History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period
• Blood donation or significant blood loss within 30 days prior to the first study drug administration
• Plasma donation within 7 days prior to the first study drug administration
• Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer
• Females who are pregnant or lactating
• Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant
• Failure to satisfy the PI of fitness to participate for any other reason
• Active infection or history of recurrent infections
• Active malignancy and history of malignancy in the past 2 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
• Antibiotic treatment within 3 months
• Chronic medical condition
• Any acute illness within 30 days prior

Other protocol defined inclusion/exclusion criteria could apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tablet vs Capsule Formulation; Single oral dose of BLD-2660 capsule or tablet formulation	Drug: BLD-2660; Randomized to active product
Experimental: Dose Proportionality; Single oral dose of BLD-2660 tablet formulation	Drug: BLD-2660; Randomized to active product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)	Measured by plasma concentration	Up to 40 days
AUC from time 0 to infinity (AUC0-inf)	Measured by plasma concentration	Up to 40 days
Maximum observed drug concentration (Cmax)	Measured by plasma concentration	Up to 40 days
Time of the maximum drug concentration (Tmax)	Measured by plasma concentration	Up to 40 days
Apparent terminal half-life (t½)	Measured by plasma concentration	Up to 40 days
Apparent terminal elimination rate constant (Kel)	Measured by plasma concentration	Up to 40 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events	Up to 40 days

Collaborators and Investigators

• Sponsor: Blade Therapeutics
• Investigators: Principal Investigator: Charlotte Lemech, MD, Scientia Clinical Research

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: B-2660-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No