FibrosisPhase 1NCT03559166
First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
A Phase 1 study testing BLD-2660 in people with Fibrosis, run by Blade Therapeutics at 1 site in Australia.
Trial summary
First in Human single ascending dose followed by multiple ascending doses in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrosis
- What is being tested?
- BLD-2660
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Jul 2018to 4 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.
- Conditions
- Fibrosis
- Being tested
- BLD-2660
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLD-2660Drug
Also called Placebo
Randomized to active product or placebo
| Study group | Role | What they receive |
|---|---|---|
| cohort 1a - starting dose | Experimental | Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers Receives: Drug: BLD-2660 |
| cohort 1b- first SAD escalation | Placebo comparator | Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation) Receives: Drug: BLD-2660 |
| 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. Receives: Drug: BLD-2660 |
| cohort 1d-3rd SAD escalation | Placebo comparator | Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation) Receives: Drug: BLD-2660 |
| 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). Receives: Drug: BLD-2660 |
| cohort 2a-1st MAD cohort | Placebo comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers Receives: Drug: BLD-2660 |
| cohort 2b-2nd MAD escalation | Placebo comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. Receives: Drug: BLD-2660 |
| cohort 2c-3rd MAD escalation | Placebo comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. Receives: Drug: BLD-2660 |
| cohort 2d-4th MAD escalation | Placebo comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. Receives: Drug: BLD-2660 |
| cohort 2e-5th MAD escalation | Placebo comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. Receives: Drug: BLD-2660 |
| cohort 2F-6th MAD escalation | Placebo comparator | Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. Receives: Drug: BLD-2660 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start11 Jul 2018
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blade Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Snyder, MD, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559166
- Sponsor's protocol ID
- B-2660-101
- Status last verified
- Mar 2020
- First submitted
- 24 Apr 2018
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03559166
- Acronym / sponsor ID
- B-2660-101
- Conditions
- Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Blade TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| cohort 1a - starting dose | Experimental | Drug: BLD-2660Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers |
| cohort 1b- first SAD escalation | Placebo comparator | Drug: BLD-2660Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation) |
| cohort 1c-2nd SAD escalation | Placebo comparator | Drug: BLD-2660Single 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. |
| cohort 1d-3rd SAD escalation | Placebo comparator | Drug: BLD-2660Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation) |
| cohort 1e-4th SAD escalation | Placebo comparator | Drug: BLD-2660Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe). |
| cohort 2a-1st MAD cohort | Placebo comparator | Drug: BLD-2660Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers |
| cohort 2b-2nd MAD escalation | Placebo comparator | Drug: BLD-2660Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. |
| cohort 2c-3rd MAD escalation | Placebo comparator | Drug: BLD-2660Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. |
| cohort 2d-4th MAD escalation | Placebo comparator | Drug: BLD-2660Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. |
| cohort 2e-5th MAD escalation | Placebo comparator | Drug: BLD-2660Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. |
| cohort 2F-6th MAD escalation | Placebo comparator | Drug: BLD-2660Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLD-2660Also: PlaceboRandomized to active product or placebo | Drug | cohort 1a - starting dose, cohort 1b- first SAD escalation, cohort 1c-2nd SAD escalation, cohort 1d-3rd SAD escalation, cohort 1e-4th SAD escalation, cohort 2F-6th MAD escalation, cohort 2a-1st MAD cohort, cohort 2b-2nd MAD escalation, cohort 2c-3rd MAD escalation, cohort 2d-4th MAD escalation, cohort 2e-5th MAD escalation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Snyder, MD principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BLD-2660 in people with Fibrosis, run by Blade Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.