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

• 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 followed by multi dose in participants with lung or liver fibrosis.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated 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
Estimated Primary Completion Date :	April 2019
Estimated Study Completion Date :	May 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: cohort 1 a-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 (optional cohort); 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 2 a-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 3a; Therapeutic oral dose (as determined by SAD and MAD data) of BLD-2660 or placebo capsule(s) administered to participants with lung fibrosis	Drug: BLD-2660; Randomized to active product or placebo; Other Name: Placebo
Placebo Comparator: cohort 3 b; Therapeutic oral dose (as determined by SAD and MAD data) of BLD-2660 or placebo capsule(s) administered to participants with liver fibrosis	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

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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

Contacts

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Contact: Nancy Havrilla, MS, RN	530.417.0496	nhavrilla@blademed.com
Contact: Shaily Jaini Garg	650.521.4496	sgarg@blademed.com

Locations

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Australia, New South Wales
Scientia Clinical Research	Recruiting
Randwick, New South Wales, Australia, 2031
Contact: James Kuo, MD +61 1800 727 874
Australia, Victoria
Nucleus Network	Recruiting
Melbourne, Victoria, Australia, 3004

Sponsors and Collaborators

Blade Therapeutics

Investigators

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Principal Investigator:	Ben Snyder, MD	Nucleus Network

More Information

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Responsible Party:	Blade Therapeutics
ClinicalTrials.gov Identifier:	NCT03559166 History of Changes
Other Study ID Numbers:	B-2660-101
First Posted:	June 18, 2018
Last Update Posted:	January 15, 2019
Last Verified:	January 2019

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

Additional relevant MeSH terms:

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