A Safety, Tolerability, and Pharmacokinetics Study of ZB002 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single-ascending doses of ZB002.

Detailed Description
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Up to approximately 48 healthy volunteers across 6 cohorts randomized to receive ZB002 or placebo as single doses.

Official Title
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A Phase 1 Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of ZB002 in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ZB002
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 effective form of contraception. Male participants must be surgically sterile or agree to use effective contraception. 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. Main 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. Treatment with any investigational drug within 30 days or 5 half-lives, whichever is greater, before the first dose of the study drug, or currently enrolled in another clinical study. Clinically significant ECG abnormality. Positive for HIV infection, active hepatitis C, or hepatitis B. Positive for COVID-19 virus. Positive QuantiFERON®-TB Gold or T-SPOT® test for Mycobacterium tuberculosis. Bacteria, viruses, systemic fungi, parasites, or other opportunistic infections within 30 days before Study Day 1. Documented history of drug abuse in the previous 12 months before Screening, or positive for urine drug screen on Screening and/or 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 or cigarette equivalents per day 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 condition that might interfere with study assessments or the safety evaluation of the investigational product. Any condition or other reason that, in the opinion of the Investigator, will make the participant not appropriate for enrollment or may prevent the participant from completing the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZB002<br> | Drug: ZB002<br>* ZB002 Single doses administered subcutaneously as solution<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo Single doses administered subcutaneously as solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | To evaluate the safety and tolerability of ZB002 in healthy participants by assessing the number, severity and type of adverse events, including changes in laboratory safety tests and electrocardiogram (ECG) | Day 1 through Day 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) | Pharmacokinetics | Day 1 through Day 120 | 
| Time for Cmax (Tmax) | Pharmacokinetics | Day 1 through Day 120 | 
| Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) | Pharmacokinetics | Day 1 through Day 120 | 
| AUC from time 0 to the last quantifiable concentration (AUClast) | Pharmacokinetics | Day 1 through Day 120 | 
| Terminal half-life (t1/2) | Pharmacokinetics | Day 1 through Day 120 | 
| Apparent clearance following extravascular dosing (CL/F) | Pharmacokinetics | Day 1 through Day 120 | 
| Apparent volume of distribution following extravascular administration (Vz/F) | Pharmacokinetics | Day 1 through Day 120 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Healthy Subjects, Healthy Participants