A Study of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants

Healthy Clinical Trial

Official title:

Phase 1, Open-label, Single Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04712006
• Other study ID #: CR108840
• Secondary ID: 64304500CRD1003
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 30, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: August 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the pharmacokinetic following single subcutaneous administration of Dose 1 or Dose 2 of JNJ-64304500 in healthy Chinese adult participants.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male or female Chinese participants whose parents and maternal and paternal grandparents are of Chinese ethnicity

• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and until Day 113

• A male participant must agree not to donate sperm for the purpose of reproduction and must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and until Day 113

• A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) at screening and a negative urine pregnancy test on Day -1 and while enrolled in this study

• Nonsmoker or agree to smoke no more than 10 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day throughout the study, if the inpatient unit allows. However, if smoking is not allowed in the inpatient unit, smokers will not be allowed to smoke while inpatient and cannot use nicotine replacement products during the inpatient period

Exclusion Criteria:

• History of any clinically significant medical illness or medical disorders the investigator considers should be exclude the participant, including (but not limited to) liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

• Had major illness or surgery, (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or until Day 113

• Plans to undergo non-major elective surgery within 4 weeks prior to study intervention administration through the end of the study

• Known or suspected allergies, hypersensitivity or intolerance to JNJ-64304500 or any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, mAbs or antibody fragments, or to any components of the formulation of JNJ-64304500 and its excipients used in this study

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-64304500
Participants will be administered with JNJ-64304500 SC (Dose 1 or 2) injection on Day 1.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Concentration of JNJ-64304500	Serum samples will be analyzed to determine concentrations of JNJ-64304500 using a validated, specific and sensitive immunoassay method.	Up to Day 113
Secondary	Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.	Up to Day 113
Secondary	Number of Participants with Antibodies to JNJ-64304500	Number of participants with antibodies to JNJ-64304500 will be reported.	Up to Day 113

External Links

•   To learn how to participate in this trial please click here.