A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 [during the study, up to 4 weeks]
Secondary Outcome Measures
- 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]
PK parameters in the blood over time.
- 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]
antidrug antibody (ADA) titers of ZB001
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy Chinese subjects between 18 and 55 years old (inclusive) at Screening
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Free of any clinically significant disease or medical condition at screening as determinedby the Investigator
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Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 32 kg/m2
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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
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Willing and able to comply with all the study requirements and provide written informedconsent for the study
Exclusion Criteria:
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Donated blood or experienced significant blood loss
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Has inadequate venous access or unsuitable veins for venipuncture and IV administrationof the study drug
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History of or have any evidence of diabetes mellitus
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History of renal impairment or inflammatory bowel disease
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History of clinically significant ear pathology, ear surgery, or hearing impairment
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Active infection
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History of malignancy
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Have undergone a surgical procedure within 3 months prior to study entry or have anysurgical procedure anticipated to be required during the study.
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Any clinically significant abnormality at screening that, inthe opinion of the Investigator, would exclude them from the study
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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
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Previously participated in a study of IGF-1 or IGF-1R-related products
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Mental Health Center | Shanghai | China | 200030 |
Sponsors and Collaborators
- Zenas BioPharma (USA), LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZB001-01-001