A First-in-Human Study of BNZ132-1-40

Bioniz Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: BNZ132-1-40

Study type: Interventional

Funder types: Industry

Identifiers

NCT03046459

BNZ-CT-101

Details and patient eligibility

About

This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family.

Full description

This is a open-label study of single doses of intravenous BNZ132-1-40 administered to healthy adult subjects. Subjects are followed for 30 days after treatment for collection of safety, PK and PD data. Cohorts of up to 6 subjects will be enrolled for each dose level.

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• males and non-pregnant, non-lactating females
• no ongoing clinically significant medical condition
• willing and able to provide informed consent
• no use of Rx or OTC medications, other than oral contraceptives

Exclusion criteria

• Recent systemic infections
• Clinically-significant abnormal clinical labs, ECG or physical examination
• Immunization 30 days prior to study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

BNZ132-1-40

Experimental group

Description:

a range of IV doses

Treatment:

Biological: BNZ132-1-40