Health TrialsbyHealthPanel

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

ConditionHealthy Volunteers (HV)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorJade Biosciences, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • JADE101

    Drug

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: JADE101 Groups 1 and 2Experimental treatment 1 intervention
Group B: JADE101 Groups 3 and 4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of single dose of JADE101 in healthy Japanese and Chinese participants

Incidence of treatment-emergent adverse events

Time frame
Day 1 through 48 weeks
2

Cmax

Maximum observed serum concentration

Time frame
Day 1 through 48 weeks
3

Tmax

Time to reach Cmax

Time frame
Day 1 through 48 weeks
4

AUClast

The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration

Time frame
Day 1 through 48 weeks

Secondary outcomes

1

Immunogenicity of JADE101 in healthy Japanese and Chinese participants

Incidence and titers of serum anti-drug antibodies (ADAs)

Time frame
Day 1 through 48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jade Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
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