Fibrosis
Conditions
Brief summary
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.
Interventions
DRUGBLD-2660
Randomized to active product
Sponsors
Blade Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed drug concentration (Cmax) | Up to 40 days | Measured by plasma concentration |
| AUC from time 0 to infinity (AUC0-inf) | Up to 40 days | Measured by plasma concentration |
| Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) | Up to 40 days | Measured by plasma concentration |
| Apparent terminal elimination rate constant (Kel) | Up to 40 days | Measured by plasma concentration |
| Time of the maximum drug concentration (Tmax) | Up to 40 days | Measured by plasma concentration |
| Apparent terminal half-life (t½) | Up to 40 days | Measured by plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 40 days | AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events |
Countries
Australia
Outcome results
None listed