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

NCT05542303 | Completed Phase 1

• 1 other identifier: ZB001-01-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0

  during the study, up to 4 weeks

Secondary Outcomes (2)

• ZB001 concentrations 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

  Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks

Study Arms (1)

ZB001 for injection

EXPERIMENTAL

Treated different dose cohorts with single intravenous injection of ZB001

Drug: ZB001 for injection

Interventions

ZB001 for injection DRUG

Dose Cohort1 (3mg/kg) ZB001 of single IV injection

ZB001 for injection

Eligibility Criteria

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

You may qualify if:

• Healthy Chinese subjects between 18 and 55 years old (inclusive) at Screening
• Free of any clinically significant disease or medical condition at screening as determinedby the Investigator
• Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 32 kg/m2
• 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
• Willing and able to comply with all the study requirements and provide written informedconsent for the study

You may not qualify if:

• Donated blood or experienced significant blood loss
• Has inadequate venous access or unsuitable veins for venipuncture and IV administrationof the study drug
• History of or have any evidence of diabetes mellitus
• History of renal impairment or inflammatory bowel disease
• History of clinically significant ear pathology, ear surgery, or hearing impairment
• Active infection
• History of malignancy
• Have undergone a surgical procedure within 3 months prior to study entry or have anysurgical procedure anticipated to be required during the study.
• Any clinically significant abnormality at screening that, inthe opinion of the Investigator, would exclude them from the study
• 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
• Previously participated in a study of IGF-1 or IGF-1R-related products
• 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

Sponsors & Collaborators

• Zenas BioPharma (USA), LLC: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 15, 2022
• Study Start: October 16, 2022
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)