Clinical trial NCT05794516: A Safety and Pharmacokinetics Study of ZB004 in Healthy Participants
Official title: A Single Ascending Dose (SAD) Study to Evaluate the Safety and Pharmacokinetics (PK) of ZB004 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Zenas BioPharma (USA), LLC
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs) to evaluate Safety and Tolerability of ZB004
timeFrame: Day 1 through Day 99
Secondary outcomes:
measure: Number of participants with treatment-emergent serious adverse events (SAEs)
timeFrame: Day 1 through Day 99
measure: Number of participants with laboratory abnormalities
timeFrame: Day 1 through Day 99
measure: Number of participants with Electrocardiogram (ECG) abnormalities
timeFrame: Day 1 through Day 99
measure: Maximum observed serum concentration (Cmax)
timeFrame: Day 1 through Day 99
measure: Time for Cmax (Tmax)
timeFrame: Day 1 through Day 99
measure: Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)
timeFrame: Day 1 through Day 99
measure: AUC from time 0 to the last quantifiable concentration (AUClast)
timeFrame: Day 1 through Day 99
measure: Terminal half-life (t½)
timeFrame: Day 1 through Day 99
measure: Apparent clearance following extravascular dosing (CL/F)
timeFrame: Day 1 through Day 99
measure: Apparent volume of distribution following extravascular administration (Vz/F)
timeFrame: Day 1 through Day 99
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: NZCR New Zealand Clinical Research
Study officials:
References: