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OpenTrials
Completed

NCT Number: NCT05542303

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Mental Health Center

Shanghai, 200030, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ZB001 for injection

Drug

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

Primary outcomes

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

    Time frame: during the study, up to 4 weeks

Secondary outcomes

  1. ZB001 concentrations in the blood over time

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

    PK parameters in the blood over time.

  2. Serum ZB001 antidrug antibody (ADA) titers

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

    antidrug antibody (ADA) titers of ZB001

Sponsors and collaborators

Lead sponsor

Zenas BioPharma (USA), LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2022
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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