Status:
COMPLETED
A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers
Lead Sponsor:
Cantero Therapeutics, a BridgeBio company
Collaborating Sponsors:
Celerion
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04876924
Start Date
April 29 2021
End Date
February 27 2022
Last Update
March 21 2022
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283