First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
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ClinicalTrials.gov Identifier: NCT03559166 |
Recruitment Status :
Completed
First Posted : June 18, 2018
Last Update Posted : March 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibrosis | Drug: BLD-2660 | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: cohort 1a - starting dose
Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers
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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 |
- Incidence of adverse events (AEs) [ Time Frame: 2 weeks ]AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559166
Australia, Victoria | |
Nucleus Network | |
Melbourne, Victoria, Australia, 3004 |
Principal Investigator: | Ben Snyder, MD | Nucleus Network |
Responsible Party: | Blade Therapeutics |
ClinicalTrials.gov Identifier: | NCT03559166 |
Other Study ID Numbers: |
B-2660-101 |
First Posted: | June 18, 2018 Key Record Dates |
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 |
Liver Cirrhosis Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases |