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

Zenas BioPharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ZB001 for injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05542303

ZB001-01-001

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

ZB001 for injection

Experimental group

Description:

Treated different dose cohorts with single intravenous injection of ZB001

Treatment:

Drug: ZB001 for injection

Drug: ZB001 for injection

Drug: ZB001 for injection