Clinical trial NCT05542303: A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects
Official title: A Single Ascending Dose, Safety, and Pharmacokinetic Study of ZB001 in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Zenas BioPharma (USA), LLC
Sponsor class: INDUSTRY
First posted: 2022-09-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
timeFrame: during the study, up to 4 weeks
Secondary outcomes:
measure: ZB001 concentrations in the blood over time
timeFrame: Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks
measure: Serum ZB001 antidrug antibody (ADA) titers
timeFrame: Before and after drug administration, performed according to the protocol visit time specified in the plan. Up to 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
References: