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

Cantero Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BBP-711

Study type: Interventional

Funder types: Industry

Identifiers

NCT04876924

ORF-01-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

92 participants in 6 patient groups, including a placebo group

BBP-711 for SAD

Experimental group

Description:

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

Treatment:

Drug: BBP-711

Placebo for SAD

Placebo Comparator group

Description:

A single dose of matching placebo will be administered orally.

Treatment:

Drug: Placebo

BBP-711 for MAD

Experimental group

Description:

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

Treatment:

Drug: BBP-711

Placebo for MAD

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

BBP-711 for SAD Food Effect

Experimental group

Description:

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

Treatment:

Drug: BBP-711

Placebo for SAD Food Effect

Placebo Comparator group

Description:

A single dose of matching placebo will be administered orally.

Treatment:

Drug: Placebo