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

NCT04876924 | Completed Phase 1 FDA Drug

• 1 other identifier: ORF-01-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Incidence of Adverse Events (AEs)

  Baseline to Day 20

Secondary Outcomes (7)

• Pharmacokinetic Assessments: Cmax

  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

  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

  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

• Pharmacodynamic Assessment: Percentage change from baseline plasma glycolate

  Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD

Study Arms (6)

BBP-711 for SAD

EXPERIMENTAL

A single dose of BBP-711 will be administered orally.

Drug: BBP-711

Placebo for SAD

PLACEBO COMPARATOR

A single dose of matching placebo will be administered orally.

Drug: Placebo

BBP-711 for MAD

EXPERIMENTAL

A dose of BBP-711 will be administered orally for multiple days.

Drug: BBP-711

Placebo for MAD

PLACEBO COMPARATOR

A dose of matching placebo will be administered orally for multiple days.

Drug: Placebo

BBP-711 for SAD Food Effect

EXPERIMENTAL

A single dose of BBP-711 will be administered orally.

Drug: BBP-711

Placebo for SAD Food Effect

PLACEBO COMPARATOR

A single dose of matching placebo will be administered orally.

Drug: Placebo

Interventions

BBP-711 DRUG

BBP-711, oral suspension

BBP-711 for MAD; BBP-711 for SAD; BBP-711 for SAD Food Effect

Placebo DRUG

Placebo matching BBP-711

Placebo for MAD; Placebo for SAD; Placebo for SAD Food Effect

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cantero Therapeutics, a BridgeBio company: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Study Officials

• Terry O'Reilly, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 7, 2021
• Study Start: April 29, 2021
• Primary Completion: February 27, 2022
• Study Completion: February 27, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)