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

NCT05542303 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-04-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Zenas BioPharma (USA), LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-16
Primary Completion
2023-04-04
Completion
2023-04-04

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05542303 on ClinicalTrials.gov