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Recruiting NCT07525947

A Single Dose, Phase 1 Study of JADE101 in Healthy Japanese and Chinese Participants

Phase I Interventional Healthy Volunteers (HV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JADE101.
Who it may be relevant to
Registry conditions: Healthy Volunteers (HV). Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JADE101 Administered Subcutaneously in Healthy Japanese and Chinese Participants.

Overview

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of JADE101 in healthy Japanese and Chinese participants.

Interventions

  • Drug JADE101
    JADE101 is supplied as sterile solution to be administered by SC injection

Primary outcome measures

  • Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants [Time frame: Day 1 through 48 weeks]
  • Cmax [Time frame: Day 1 through 48 weeks]
  • Tmax [Time frame: Day 1 through 48 weeks]
  • AUClast [Time frame: Day 1 through 48 weeks]
  • T1/2 [Time frame: Day 1 through 48 weeks]
Secondary outcome measures (1)
  • Immunogenicity of JADE101 in healthy Japanese and Chinese participants [Time frame: Day 1 through 48 weeks]

Eligibility criteria

Inclusion criteria

  • Healthy male or female participants 18-55 years of age, inclusive
  • First-generation Japanese or Chinese participants born in Japan/China
  • A body weight between 40-100 kg and a body mass index (BMI) between 18.0 - 32.0 kg/m2 (all inclusive) at screening
  • Willing and able to comply with the study site stay, scheduled visits, and study procedures
  • Willing and able to comply with contraceptive and lifestyle requirements from admission through the end of the study

Exclusion criteria

  • Harmful alcohol use
  • Smoking/vaping or heavy tobacco use within 2 years prior to screening
  • Known history of abuse of illicit drugs
  • Nursing, lactating or pregnant, or who have plans to become pregnant during the study
  • Known history of clinically significant disease
  • Known history of immunodeficiency disorder
  • History of clinically significant allergic reactions or hypersensitivity

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Parexel Early Phase Clinical Unit (EPCU) — Glendale

Identifiers

NCT: NCT07525947 · JADE101-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗