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Active, Not Recruiting

NCT Number: NCT07059312

A Phase 1 Study of JADE101 in Healthy Participants

This is a Phase 1, first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE101 compared to placebo in healthy participants.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NZCR

Auckland, New Zealand

About this study

This is a single center, Phase 1, double-blind, placebo-controlled, randomized, first-in-human (FIH), single ascending dose study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JADE101 in healthy participants. The study will enroll approximately 32 healthy volunteers. JADE101 will be administered by a subcutaneous injection. The results of this study will help inform the dosing and frequency of dosing in future studies of JADE101.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female participants 18-55 years of age, inclusive
  • A body weight between 50-100 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 using two methods of contraception (one being highly effective) 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

Treatment and study plan

JADE101

Drug

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

Placebo

Drug

Placebo solution to be administered at a matching volume by SC injection.

Primary outcomes

  1. Safety and Tolerability of Single Ascending Doses of JADE101 in Healthy Participants

    Time frame: Day 1 through 48 weeks

    Incidence of treatment-emergent adverse events

Secondary outcomes

  1. Cmax

    Time frame: Day 1 through 48 weeks

    Maximum observed serum concentration

  2. Tmax

    Time frame: Day 1 through 48 weeks

    Time to reach Cmax

  3. AUClast

    Time frame: Day 1 through 48 weeks

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

  4. T1/2

    Time frame: Day 1 through 48 weeks

    Apparent first-order terminal elimination half-life

Sponsors and collaborators

Lead sponsor

Jade Biosciences, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JADE101 Administered Subcutaneously in Healthy Volunteers

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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