First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis

• ClinicalTrials.gov Identifier: NCT03559166
• Recruitment Status: Completed
• First Posted: June 18, 2018
• Last Update Posted: March 19, 2020
• Sponsor: Blade Therapeutics
• Information provided by (Responsible Party): Blade Therapeutics

Study Description

Brief Summary:

First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.

Condition or disease	Intervention/treatment	Phase
Fibrosis	Drug: BLD-2660	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Randomized, double-blind, placebo controlled
• Primary Purpose: Treatment
• Official Title: A Phase Ia/Ib, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BLD-2660 in Healthy Volunteers and Patients With Lung Fibrosis or Liver Fibrosis
• Actual Study Start Date: July 11, 2018
• Actual Primary Completion Date: October 4, 2019
• Actual Study Completion Date: October 4, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: cohort 1a - starting dose; Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 1b- first SAD escalation; Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation)	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 1c-2nd SAD escalation; Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (2nd dose escalation) in fasting state, followed by washout period and then single oral dose of BLD-2660 or placebo administered to healthy volunteers in fed state.	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 1d-3rd SAD escalation; Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation)	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 1e-4th SAD escalation; Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe).	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 2a-1st MAD cohort; Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 2b-2nd MAD escalation; Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 2c-3rd MAD escalation; Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 2d-4th MAD escalation; Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 2e-5th MAD escalation; Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 2F-6th MAD escalation; Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events (AEs) [ Time Frame: 2 weeks ]
   AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
2. Any observed changes in clinical safety laboratory results [ Time Frame: 2 weeks ]
   Assessed by reviewing any observed changes in CBC, serum chemistry or urinalysis from baseline by dose. Results in subjects dosed with BLD-2660 treatment will be compared to those dosed with placebo.
3. Any observed changes in physical examinations [ Time Frame: 2 weeks ]
   Assessed by reviewing any observed changes in physical examinations from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.
4. Any observed changes in vital signs [ Time Frame: 2 weeks ]
   Assessed by reviewing any observed changes in vital signs from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.
5. Any observed changes in ECG [ Time Frame: 2 weeks ]
   Assessed by reviewing any observed changes in ECG from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Able to provide written informed consent
• Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
• 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 30 days following completion of dosing
• Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1
• Normal BMI except liver fibrosis participants (BMI 18 to ≤35 kg/m2)
• Be in general good health
• Clinical laboratory values within normal range
• Lung fibrosis participants-a diagnosis of lung fibrosis,
• Liver fibrosis participants-a diagnosis of liver fibrosis; some abnormal laboratory values will be acceptable for the following; platelet count, albumin, serum creatinine and neutrophil-leukocyte ration

Exclusion Criteria:

• 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 60 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 5 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
• Chronic obstructive pulmonary disease
• Antibiotic treatment within 3 months
• Chronic medical condition

Contacts and Locations

Locations

Australia, Victoria

Nucleus Network

Melbourne, Victoria, Australia, 3004

Sponsors and Collaborators

Blade Therapeutics

Investigators

• Principal Investigator: Ben Snyder, MD; Nucleus Network

More Information

• Responsible Party: Blade Therapeutics
• ClinicalTrials.gov Identifier: NCT03559166
• Other Study ID Numbers: B-2660-101
• First Posted: June 18, 2018
• Last Update Posted: March 19, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Liver Cirrhosis; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases