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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05542303
• Other study ID #: ZB001-01-001
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2022
• Est. completion date: April 4, 2023

Study information

• Verified date: September 2023
• Source: Zenas BioPharma (USA), LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ZB001 for injection
Dose Cohort1 (3mg/kg) ZB001 of single IV injection
• ZB001 for injection
Dose Cohort2 (10mg/kg) ZB001 of single IV injection
• ZB001 for injection
Dose Cohort3 (20mg/kg) ZB001 of single IV injection

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zenas BioPharma (USA), LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0		during the study, up to 4 weeks
Secondary	ZB001 concentrations in the blood over time	PK parameters 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
Secondary	Serum ZB001 antidrug antibody (ADA) titers	antidrug antibody (ADA) titers of ZB001	Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks