A Safety and Pharmacokinetics Study of ZB004 in Healthy Participants

NCT ID: NCT05794516

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-19
• Study Completion Date: 2024-03-21

Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of single-ascending doses of ZB004.

Detailed Description

Up to approximately 40 healthy volunteers across 5 cohorts randomized to receive ZB004 or placebo as single doses.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ZB004

Group Type: EXPERIMENTAL

ZB004

Intervention Type: DRUG

ZB004 single doses administered subcutaneously as solution

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo single doses administered subcutaneously as solution

Interventions

ZB004

ZB004 single doses administered subcutaneously as solution

Intervention Type: DRUG

Placebo

Placebo single doses administered subcutaneously as solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male or female participants 18 to 55 years of age.
• Body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants; body mass index of 18 to 35 kg/m^2 for both male and female participants.
• Considered in good health as determined by the Investigator.
• Female participants of child-bearing potential must agree to abstinence or use an highly effective form of contraception. Female participants must also refrain from donation of eggs from the signing of the informed consent to 6 months after receiving their dose of study drug.
• Male participants must be surgically sterile or agree to use effective contraception. Male participants must also agree not to donate sperm from the signing of the informed consent to 6 months after the last scheduled dose of the study drug.
• Willing and able to understand the characteristics and purposes of the study, including possible risks involved, and willing to comply with all the study requirements and provide written informed consent for the study.

Exclusion Criteria

• Surgery within 4 weeks before Screening or planned surgery during the clinical study.
• Use of prescription medications, biological products, or other medicines within 2 weeks before Study Day 1 or 5 half-lives of the product, whichever is greater. Use of over-the-counter medications or vitamins/dietary supplements within 7 days of dosing unless considered by the Investigator to not pose a risk or impact the study results.
• Clinically significant ECG abnormality.
• Positive for HIV, active hepatitis C or B, Covid-19 virus, tuberculosis.
• Bacteria, viruses, systemic fungi, parasites, or other opportunistic infections within 30 days before Study Day 1.
• History of drug abuse in the previous 12 months before Screening, or positive for urine drug Screening (Day -28 to Day -1).
• Donated blood (including component blood) or lost > 400 mL within 3 months before Screening or received a transfusion within 3 months of Screening.
• History of relevant allergies (including allergy to any murine or human-derived protein or immunoglobulin products, rubber or latex, or other allergies that in the opinion of the Investigator make inclusion in the study inappropriate).
• Average daily smoking > 10 cigarettes/day (or equivalent) within 6 months of Screening.
• Consume > 14 standard units of alcohol per week (1 standard unit is equivalent to approximately 360 mL of beer, 45 mL of spirits with 40% alcohol, or 150 mL of wine) or a positive alcohol breath test on Day -1.
• Any disease that might interfere with the safety evaluation of the investigational product.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zenas BioPharma (USA), LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NZCR New Zealand Clinical Research

Christchurch, , New Zealand

Countries

New Zealand

Other Identifiers

ZB004-01-001

Identifier Type: -

Identifier Source: org_study_id