FibrosisPhase 1NCT04001998
Healthy Volunteer Study Comparing Tablet and Capsule Formulations
A Phase 1 study testing BLD-2660 in people with Fibrosis, run by Blade Therapeutics at 1 site in Australia.
Trial summary
Single center, randomized, open label, two-part crossover study designed to evaluate the PK, food effect, dose proportionality, safety, and tolerability of BLD-2660 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 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?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2021to Jul 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- 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
- Normal BMI (18 to ≤ 35 kg/m2)
- 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 90 days following completion of dosing
- Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test on Day -1
- Be in general good health
- Clinical laboratory values within normal range
Who cannot join
- Recent wound, or presence of an ongoing non-healing skin wound
- 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 30 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
Show all 15Show fewer
- 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 2 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
- Antibiotic treatment within 3 months
- Chronic medical condition
- Any acute illness within 30 days prior
- Other protocol defined inclusion/exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part, Open Label, Complete Crossover Study to Compare the Tablet and Capsule Formulations of BLD-2660, Including a Food Effect Assessment of the Tablet Formulation, and to Assess Dose Proportionality Following Single Oral Doses of BLD-2660 in Tablet Formulation
Single center, randomized, open label, two-part crossover study designed to evaluate the PK, food effect, dose proportionality, safety, and tolerability of BLD-2660 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
Randomized to active product
| Study group | Role | What they receive |
|---|---|---|
| Tablet vs Capsule Formulation | Experimental | Single oral dose of BLD-2660 capsule or tablet formulation Receives: Drug: BLD-2660 |
| Dose Proportionality | Experimental | Single oral dose of BLD-2660 tablet formulation Receives: Drug: BLD-2660 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Measured by plasma concentration
Measured: Up to 40 days
AUC from time 0 to infinity (AUC0-inf)
Measured by plasma concentration
Measured: Up to 40 days
Maximum observed drug concentration (Cmax)
Measured by plasma concentration
Measured: Up to 40 days
Time of the maximum drug concentration (Tmax)
Measured by plasma concentration
Measured: Up to 40 days
Apparent terminal half-life (t½)
Measured by plasma concentration
Measured: Up to 40 days
Apparent terminal elimination rate constant (Kel)
Measured by plasma concentration
Measured: Up to 40 days
Secondary outcomes (1)
Incidence of adverse events (AEs)
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study startFeb 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Why it stopped: On hold to determine chosen formulations
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blade Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlotte Lemech, MD, Principal investigator, Scientia Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001998
- Sponsor's protocol ID
- B-2660-102
- Status last verified
- Sep 2020
- First submitted
- 26 Jun 2019
- Last updated
- 30 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Open Label, Complete Crossover Study to Compare the Tablet and Capsule Formulations of BLD-2660, Including a Food Effect Assessment of the Tablet Formulation, and to Assess Dose Proportionality Following Single Oral Doses of BLD-2660 in Tablet Formulation
- ClinicalTrials.gov ID
- NCT04001998
- Acronym / sponsor ID
- B-2660-102
- Conditions
- Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: On hold to determine chosen formulations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Blade TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 28 Jun 2019 (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.
Single center, randomized, open label, two-part crossover study designed to evaluate the PK, food effect, dose proportionality, safety, and tolerability of BLD-2660 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet vs Capsule Formulation | Experimental | Drug: BLD-2660Single oral dose of BLD-2660 capsule or tablet formulation |
| Dose Proportionality | Experimental | Drug: BLD-2660Single oral dose of BLD-2660 tablet formulation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Able to provide written informed consent
- Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
- Normal BMI (18 to ≤ 35 kg/m2)
- 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 90 days following completion of dosing
Key exclusion criteria (15 listed)
- Recent wound, or presence of an ongoing non-healing skin wound
- 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 30 days prior to the first study drug administration
- Plasma donation within 7 days prior to the first study drug administration
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-2660Randomized to active product | Drug | Dose Proportionality, Tablet vs Capsule Formulation |
Primary outcome
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Time frame: Up to 40 days
Measured by plasma concentration
AUC from time 0 to infinity (AUC0-inf)
Time frame: Up to 40 days
Measured by plasma concentration
Maximum observed drug concentration (Cmax)
Time frame: Up to 40 days
Measured by plasma concentration
Time of the maximum drug concentration (Tmax)
Time frame: Up to 40 days
Measured by plasma concentration
Apparent terminal half-life (t½)
Time frame: Up to 40 days
Measured by plasma concentration
Apparent terminal elimination rate constant (Kel)
Time frame: Up to 40 days
Measured by plasma concentration
1 secondary outcome
Incidence of adverse events (AEs)
Time frame: Up to 40 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Charlotte Lemech, MD principal investigator
Scientia Clinical Research
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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 30 Oct 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) (time frame: Up to 40 days). The study lists 6 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 30 Oct 2020.