CClinicalTrials.gg
WithdrawnNCT04712006Updated Sep 1, 2021

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

A Phase 1 interventional study of JNJ-64304500 in Healthy, sponsored by Janssen Research & Development, LLC. Withdrawn at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-01.

Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Sponsor Decision.
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Cohort 1: JNJ-64304500

    Participants will receive single subcutaneous (SC) Dose 1 of JNJ-64304500 on Day 1.

    Drug: JNJ-64304500

  • Experimental
    Cohort 2: JNJ-64304500

    Participants will receive single SC Dose 2 of JNJ-64304500 on Day 1.

    Drug: JNJ-64304500

Interventions

  • DrugJNJ-64304500

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

06

What researchers measure

Primary outcomes

  1. Serum Concentration of JNJ-64304500

    Serum samples will be analyzed to determine concentrations of JNJ-64304500 using a validated, specific and sensitive immunoassay method.

    Time frame: Up to Day 113

Secondary outcomes

  1. 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.

    Time frame: Up to Day 113

  2. Number of Participants with Antibodies to JNJ-64304500

    Number of participants with antibodies to JNJ-64304500 will be reported.

    Time frame: Up to Day 113

07

Study locations

1 site
  • Peking University Third Hospital
    Beijing, 100089, China
08

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04712006
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Jan 15, 2021
Start date
May 30, 2021 (estimated)
Primary completion
Aug 27, 2021 (estimated)
Completion
Oct 30, 2021 (estimated)
Last update
Sep 1, 2021

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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