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A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT04876924
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : May 12, 2021
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
Cantero Therapeutics, a BridgeBio company

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: BBP-711 Drug: Placebo Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : December 20, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: BBP-711 for SAD
A single dose of BBP-711 will be administered orally.
 Drug: BBP-711
BBP-711, oral suspension
Placebo Comparator: Placebo for SAD
A single dose of matching placebo will be administered orally.
 Drug: Placebo
Placebo matching BBP-711
Experimental: BBP-711 for MAD
A dose of BBP-711 will be administered orally for multiple days.
 Drug: BBP-711
BBP-711, oral suspension
Placebo Comparator: Placebo for MAD
A dose of matching placebo will be administered orally for multiple days.
 Drug: Placebo
Placebo matching BBP-711
Experimental: BBP-711 for SAD Food Effect
A single dose of BBP-711 will be administered orally.
 Drug: BBP-711
BBP-711, oral suspension
Placebo Comparator: Placebo for SAD Food Effect
A single dose of matching placebo will be administered orally.
 Drug: Placebo
Placebo matching BBP-711


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: Baseline to Day 20 ]
    Incidence of Adverse Events (AEs)


Secondary Outcome Measures :
  1. 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 ]
    Maximum observed plasma concentration (Cmax)

  2. 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 ]
    Minimum observed plasma concentration (Cmin)

  3. 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 ]
    Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC(0-last)) computed using the linear trapezoidal rule

  4. Pharmacodynamic Assessment: Baseline plasma glycolate [ Time Frame: Baseline ]
    Baseline plasma glycolate

  5. 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 ]
    Percentage change from baseline plasma glycolate

  6. Pharmacodynamic Assessment: Baseline 24 Hour urinary glycolate:creatinine ratio [ Time Frame: Baseline ]
    Baseline 24 Hour urinary glycolate:creatinine ratio

  7. 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 ]
    Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04876924


Contacts
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Contact: Zaira Bencomo +1 602-437-0097 info@celerion.com

Locations
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United States, Arizona
Celerion Recruiting
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Cantero Therapeutics, a BridgeBio company
Celerion
Investigators
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Principal Investigator: Terry O'Reilly, MD Celerion
More Information
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Responsible Party: Cantero Therapeutics, a BridgeBio company
ClinicalTrials.gov Identifier: NCT04876924    
Other Study ID Numbers: ORF-01-001
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No