A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects

A Single Ascending Dose, Safety, and Pharmacokinetic Study of ZB001 in Healthy Chinese Subjects

The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody (mAb) targeting human IGF-1R. This clinical trial will examine the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of ZB001 in healthy Chinese subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ZB001 for injection; Drug: ZB001 for injection; Drug: ZB001 for injection

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200030
    • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy Chinese subjects between 18 and 55 years old (inclusive) at Screening
2. Free of any clinically significant disease or medical condition at screening as determinedby the Investigator
3. Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 32 kg/m2
4. Women must be of non-childbearing potential:Surgically sterile; no menses for ≥ 12 months AND a follicle-stimulating hormone level>40 IU/L at screening; or meeting the definition of "postmenopausal range" based onscreening laboratory results
5. Willing and able to comply with all the study requirements and provide written informedconsent for the study

Exclusion Criteria:

1. Donated blood or experienced significant blood loss
2. Has inadequate venous access or unsuitable veins for venipuncture and IV administrationof the study drug
3. History of or have any evidence of diabetes mellitus
4. History of renal impairment or inflammatory bowel disease
5. History of clinically significant ear pathology, ear surgery, or hearing impairment
6. Active infection
7. History of malignancy
8. Have undergone a surgical procedure within 3 months prior to study entry or have anysurgical procedure anticipated to be required during the study.
9. Any clinically significant abnormality at screening that, inthe opinion of the Investigator, would exclude them from the study
10. Received the last dose of an investigational drug or treatment with a medical devicewithin 30 days or 5 half-lives prior to screening or currentlyparticipating in another study of an investigational drug or medical device
11. Previously participated in a study of IGF-1 or IGF-1R-related products
12. Any medical condition or laboratory abnormality, that in the opinion of the Investigator, would prevent the subject from completing the study, pose a risk to the subject, or confound the ability to interpret study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZB001 for injection; Treated different dose cohorts with single intravenous injection of ZB001	Drug: ZB001 for injection; Dose Cohort1 (3mg/kg) ZB001 of single IV injection; Drug: ZB001 for injection; Dose Cohort2 (10mg/kg) ZB001 of single IV injection; Drug: ZB001 for injection; Dose Cohort3 (20mg/kg) ZB001 of single IV injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0	during the study, up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ZB001 concentrations in the blood over time	PK parameters in the blood over time.	Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks
Serum ZB001 antidrug antibody (ADA) titers	antidrug antibody (ADA) titers of ZB001	Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks

Collaborators and Investigators

• Sponsor: Zenas BioPharma (USA), LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2022
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ZB001-01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No