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First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1a - starting dose | Experimental | Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers |
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| cohort 1b- first SAD escalation | Placebo Comparator | Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation) |
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| cohort 1c-2nd SAD escalation | Placebo Comparator | 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. |
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| cohort 1d-3rd SAD escalation | Placebo Comparator | Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation) |
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| cohort 1e-4th SAD escalation | Placebo Comparator | Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLD-2660 | Drug | Randomized to active product or placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events | 2 weeks |
| Any observed changes in clinical safety laboratory results | 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. | 2 weeks |
| Any observed changes in physical examinations | 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. | 2 weeks |
| Any observed changes in vital signs | 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. | 2 weeks |
| Any observed changes in ECG | 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. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Snyder, MD | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized, double-blind, placebo controlled
| cohort 2a-1st MAD cohort | Placebo Comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers |
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| cohort 2b-2nd MAD escalation | Placebo Comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. |
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| cohort 2c-3rd MAD escalation | Placebo Comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. |
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| cohort 2d-4th MAD escalation | Placebo Comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. |
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| cohort 2e-5th MAD escalation | Placebo Comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. |
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| cohort 2F-6th MAD escalation | Placebo Comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. |
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