HealthyPhase 1NCT04876924
A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers
A Phase 1 study testing BBP-711 in people with Healthy, run by Cantero Therapeutics, a BridgeBio company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BBP-711
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2021to 27 Feb 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female who is 18 to 65 years old,
- Weight >50 kg and ≤110 kg at Screening
- Body mass index (BMI) 20 to 32 kg/m2, inclusive, at Screening
- In generally good health
- Nonsmoker, or not using tobacco or nicotine-containing products for at least 6 months
Who cannot join
- Use of any over-the-counter medications, including herbals or routine vitamins or minerals, or other supplements, within 7 days before admission to the research center.
- Pregnant or breastfeeding
- eGFR <90 mL/minute
- Abnormal ECG
- Abnormal laboratory results
- Positive test result for HIV, Hepatitis B, Hepatitis C, or COVID-19
- History of substance dependency (alcohol or other drugs of abuse) in the last 2 years
- Use of study drug in any clinical trial within 30 days of admission to the research center, or in the active follow-up phase of another clinical trial involving study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-controlled, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of BBP-711 (ORF-229) in Healthy Adult Subjects
The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers.
Read the detailed description
This is a single-center, two-part, randomized, double-blinded, placebo-controlled, ascending dose study of BBP-711 in healthy male and female adult volunteers. The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers. Each volunteer will participate in the study for about 20 days.
- Conditions
- Healthy
- Being tested
- BBP-711, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBP-711Drug
BBP-711, oral suspension
PlaceboDrug
Placebo matching BBP-711
| Study group | Role | What they receive |
|---|---|---|
| BBP-711 for SAD | Experimental | A single dose of BBP-711 will be administered orally. Receives: Drug: BBP-711 |
| Placebo for SAD | Placebo comparator | A single dose of matching placebo will be administered orally. Receives: Drug: Placebo |
| BBP-711 for MAD | Experimental | A dose of BBP-711 will be administered orally for multiple days. Receives: Drug: BBP-711 |
| Placebo for MAD | Placebo comparator | A dose of matching placebo will be administered orally for multiple days. Receives: Drug: Placebo |
| BBP-711 for SAD Food Effect | Experimental | A single dose of BBP-711 will be administered orally. Receives: Drug: BBP-711 |
| Placebo for SAD Food Effect | Placebo comparator | A single dose of matching placebo will be administered orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence of Adverse Events (AEs)
Measured: Baseline to Day 20
Secondary outcomes (7)
Pharmacokinetic Assessments: Cmax
Maximum observed plasma concentration (Cmax)
Measured: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
Pharmacokinetic Assessments: Cmin
Minimum observed plasma concentration (Cmin)
Measured: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
Pharmacokinetic Assessments: AUC
Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC(0-last)) computed using the linear trapezoidal rule
Measured: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
Pharmacodynamic Assessment: Baseline plasma glycolate
Baseline plasma glycolate
Measured: Baseline
Pharmacodynamic Assessment: Percentage change from baseline plasma glycolate
Percentage change from baseline plasma glycolate
Measured: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
Pharmacodynamic Assessment: Baseline 24 Hour urinary glycolate:creatinine ratio
Baseline 24 Hour urinary glycolate:creatinine ratio
Measured: Baseline
Pharmacodynamic Assessment: Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio
Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio
Measured: Urine samples will be taken pre-dose up to Day 3 for SAD and pre-dose up to Day 7 for MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start29 Apr 2021
- Primary completion27 Feb 2022
- Study completion27 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantero Therapeutics, a BridgeBio company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Terry O'Reilly, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876924
- Sponsor's protocol ID
- ORF-01-001
- Status last verified
- Mar 2022
- First submitted
- 3 May 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blinded, Placebo-controlled, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of BBP-711 (ORF-229) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04876924
- Acronym / sponsor ID
- ORF-01-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cantero Therapeutics, a BridgeBio companyIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 7 May 2021 (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.
The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers.
Detailed description
This is a single-center, two-part, randomized, double-blinded, placebo-controlled, ascending dose study of BBP-711 in healthy male and female adult volunteers. The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers. Each volunteer will participate in the study for about 20 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BBP-711 for SAD | Experimental | Drug: BBP-711A single dose of BBP-711 will be administered orally. |
| Placebo for SAD | Placebo comparator | Drug: PlaceboA single dose of matching placebo will be administered orally. |
| BBP-711 for MAD | Experimental | Drug: BBP-711A dose of BBP-711 will be administered orally for multiple days. |
| Placebo for MAD | Placebo comparator | Drug: PlaceboA dose of matching placebo will be administered orally for multiple days. |
| BBP-711 for SAD Food Effect | Experimental | Drug: BBP-711A single dose of BBP-711 will be administered orally. |
| Placebo for SAD Food Effect | Placebo comparator | Drug: PlaceboA single dose of matching placebo will be administered orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male or female who is 18 to 65 years old,
- Weight >50 kg and ≤110 kg at Screening
- Body mass index (BMI) 20 to 32 kg/m2, inclusive, at Screening
- In generally good health
- Nonsmoker, or not using tobacco or nicotine-containing products for at least 6 months
Key exclusion criteria (8 listed)
- Use of any over-the-counter medications, including herbals or routine vitamins or minerals, or other supplements, within 7 days before admission to the research center.
- Pregnant or breastfeeding
- eGFR <90 mL/minute
- Abnormal ECG
- Abnormal laboratory results
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 |
|---|---|---|
| BBP-711BBP-711, oral suspension | Drug | BBP-711 for MAD, BBP-711 for SAD, BBP-711 for SAD Food Effect |
| PlaceboPlacebo matching BBP-711 | Drug | Placebo for MAD, Placebo for SAD, Placebo for SAD Food Effect |
Primary outcome
Safety and Tolerability
Time frame: Baseline to Day 20
Incidence of Adverse Events (AEs)
7 secondary outcomes
Pharmacokinetic Assessments: Cmax
Time frame: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
Pharmacokinetic Assessments: Cmin
Time frame: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
Pharmacokinetic Assessments: AUC
Time frame: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
Pharmacodynamic Assessment: Baseline plasma glycolate
Time frame: Baseline
Pharmacodynamic Assessment: Percentage change from baseline plasma glycolate
Time frame: Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD
Pharmacodynamic Assessment: Baseline 24 Hour urinary glycolate:creatinine ratio
Time frame: Baseline
Pharmacodynamic Assessment: Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio
Time frame: Urine samples will be taken pre-dose up to Day 3 for SAD and pre-dose up to Day 7 for MAD
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 21 Mar 2022.
- 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.
Terry O'Reilly, MD principal investigator
Celerion
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 BBP-711 in people with Healthy, run by Cantero Therapeutics, a BridgeBio company at 1 site in United States.
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 5 inclusion and 8 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 21 Mar 2022. 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 United States. 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?
Safety and Tolerability (time frame: Baseline to Day 20). 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 21 Mar 2022.