A Safety and Pharmacokinetics Study of ZB004 in Healthy Participants

NCT05794516 | Completed Phase 1

• 1 other identifier: ZB004-01-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events (TEAEs) to evaluate Safety and Tolerability of ZB004

  Day 1 through Day 99

Secondary Outcomes (10)

• Number of participants with treatment-emergent serious adverse events (SAEs)

  Day 1 through Day 99

• Number of participants with laboratory abnormalities

  Day 1 through Day 99

• Number of participants with Electrocardiogram (ECG) abnormalities

  Day 1 through Day 99

• Maximum observed serum concentration (Cmax)

  Day 1 through Day 99

• Time for Cmax (Tmax)

  Day 1 through Day 99

Study Arms (2)

ZB004

EXPERIMENTAL

Drug: ZB004

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ZB004 DRUG

ZB004 single doses administered subcutaneously as solution

ZB004

Placebo DRUG

Placebo single doses administered subcutaneously as solution

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zenas BioPharma (USA), LLC: lead

Study Sites (1)

NZCR New Zealand Clinical Research

Christchurch, New Zealand

Location

Study Design

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

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: June 19, 2023
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

NZ (1)