Healthy VolunteersPhase 1NCT07059312
A Phase 1 Study of JADE101 in Healthy Participants
A Phase 1 study testing JADE101 in people with Healthy Volunteers, run by Jade Biosciences, Inc. at 1 site in New Zealand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- JADE101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNew Zealand
- Study dates
- 17 Aug 2025to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- JADE101, Placebo
- Keywords
- JADE101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JADE101Drug
JADE101 is supplied as sterile solution to be administered by SC injection.
PlaceboDrug
Placebo solution to be administered at a matching volume by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| JADE101 | Experimental | Subcutaneous (SC) injection of JADE101 Receives: Drug: JADE101 |
| Placebo | Placebo comparator | Subcutaneous (SC) injection of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Single Ascending Doses of JADE101 in Healthy Participants
Incidence of treatment-emergent adverse events
Measured: Day 1 through 48 weeks
Secondary outcomes (4)
Cmax
Maximum observed serum concentration
Measured: Day 1 through 48 weeks
Tmax
Time to reach Cmax
Measured: Day 1 through 48 weeks
AUClast
The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration
Measured: Day 1 through 48 weeks
T1/2
Apparent first-order terminal elimination half-life
Measured: Day 1 through 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start17 Aug 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jade Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Li, MD, Study director, Jade Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059312
- Sponsor's protocol ID
- JADE101-01
- Status last verified
- Dec 2025
- First submitted
- 27 Jun 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07059312
- Acronym / sponsor ID
- JADE101-01
- Conditions
- Healthy Volunteers
- Keywords
- JADE101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jade Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JADE101 | Experimental | Drug: JADE101Subcutaneous (SC) injection of JADE101 |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous (SC) injection of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JADE101JADE101 is supplied as sterile solution to be administered by SC injection. | Drug | JADE101 |
| PlaceboPlacebo solution to be administered at a matching volume by SC injection. | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Li, MD study director
Jade Biosciences, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JADE101 in people with Healthy Volunteers, run by Jade Biosciences, Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Single Ascending Doses of JADE101 in Healthy Participants (time frame: Day 1 through 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.