Atopic DermatitisPhase 1BYN-001-101NCT07746817
A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis
A Phase 1 study testing BYN-001 in people with Atopic Dermatitis and Healthy Participants, run by Bionyra Pharma at 1 site in Australia.
Trial summary
This first-in-human study evaluates BYN-001, a humanized IgG1 monoclonal antibody targeting interleukin-25 (IL-25), a cytokine implicated in atopic dermatitis. Parts A and B are randomized, double-blind, placebo-controlled single and multiple ascending dose cohorts in healthy adults, that will assess safety… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Healthy Participants
- What is being tested?
- BYN-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Aug 2026to 31 Dec 2028
- 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
Part A and B Key Inclusion Criteria:
- Age 18-55 years of age
- Must be in good health with no significant medical conditions
- Willing and able to attend all study visits and comply with study requirements
- Able and willing to provide written informed consent
Part A and B Exclusion Criteria:
- Evidence of clinically significant condition or disease
- Any physical or psychosocial condition that prohibits study completion
- Know history of illicit drug use or abuse, alcoholism and/or smoking more than -5 cigarettes a day in the prior 3 months
- History of sever allergic reactions of hypersensitivity
Part C Inclusion Criteria
- Age 18-55 years of age
- Must be in good health with no significant medical conditions
- Willing and able to attend all study visits and comply with study requirements
- Able and willing to provide written informed consent
- Documented chromic atopic dermatitis within 1 year prior to screening
- Moderate to severe atopic dermatitis
Part C Key Exclusion Criteria
- Evidence of clinically significant condition or disease
- Any physical or psychosocial condition that prohibits study completion
- Know history of illicit drug use or abuse, alcoholism and/or smoking more than 5 cigarettes a day in the prior 3 months
- History of sever allergic reactions of hypersensitivity
- Incomplete washout of prior atopic dermatitis medications
- Other confounding skin diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Doherty Clinical Trials
Melbourne, Victoria, 3002
James McCarthy Prof, +61 399704209, jmccarthy@dohertyclinicaltrials.com
About this study
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BYN-001 in Healthy Adult Participants and Participants With Moderate to Severe Atopic Dermatitis
This first-in-human study evaluates BYN-001, a humanized IgG1 monoclonal antibody targeting interleukin-25 (IL-25), a cytokine implicated in atopic dermatitis. Parts A and B are randomized, double-blind, placebo-controlled single and multiple ascending dose cohorts in healthy adults, that will assess safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of BYN-001. Part C will assess BYN-001 in adults with moderate to severe atopic dermatitis.
Read the detailed description
Atopic dermatitis (AD) is a common chronic inflammatory skin disease for which current type 2 cytokine-targeted biologics leave a substantial proportion of patients with an inadequate response or residual pruritus. IL-25 acts upstream of type 2 inflammation and has been shown to drive pruritus and epidermal barrier dysfunction. BYN-001 selectively binds and neutralises IL-25 (with a long predicted terminal half-life), supporting an infrequent dosing interval.
Part A will consist of a single ascending dose (SAD) design, with administration in up to five cohorts. Part B will consist of a multiple ascending dose (MAD) design, with administration in up to three cohorts. Both parts will enroll healthy participants and will be conducted under a sentinel dosing approach, with dose escalation decisions governed by a Safety Monitoring Committee (SMC) at each escalation step.
Part C will enroll participants with moderate to severe AD.
- Conditions
- Atopic Dermatitis, Healthy Participants
- Being tested
- BYN-001, Placebo
- Keywords
- IL-25, Monoclonal antibody, First-in-human, Multiple ascending dose, Single ascending dose, Atopic dermatitis, Healthy Participant
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BYN-001Biological
BYN-001 will be administered by subcutaneous injection. In Part A, a Single Ascending Dose (SAD) design will be implemented across up to five cohorts, with healthy participants receiving a single dose of BYN-001. In Part B, a Multiple Ascending Dose (MAD) design will be implemented with healthy participants receiving multiple doses of BYN-001.
PlaceboDrug
Part A SAD healthy participants will receive a single subcutaneous injection of placebo. Part B MAD healthy participants will receive multiple doses of subcutaneous injection of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Experimental, Part A, SAD Cohorts: BYN-001 Active drug | Experimental | Healthy participants will receive a single dose of BYN-001 in a dose escalation format Receives: Biological: BYN-001 |
| Placebo Comparator, Part A, SAD Cohorts Placebo | Placebo comparator | Healthy participants will receive a single dose of placebo comparator Receives: Drug: Placebo |
| Experimental, Part B, MAD Cohorts: BYN-001 Active drug | Experimental | Healthy participants will receive a repeated doses of BYN-001 in a dose escalation format Receives: Biological: BYN-001 |
| Placebo Comparator Part B, MAD Cohorts: BYN-001 Placebo | Placebo comparator | Healthy participants will receive repeated doses of placebo comparator Receives: Drug: Placebo |
| Experimental, Part C, Participants with mild to severe atopic dermatitis, BYN-001 | Experimental | Participants with mild to severe atopic dermatitis will be randomized to receive repeat doses of BYN-001 Receives: Biological: BYN-001 |
| Placebo Comparator, Part C, Participants with mild to severe atopic dermatitis, Placebo | Placebo comparator | Participants with mild to severe atopic dermatitis will be randomized to receive repeat doses of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Includes clinically relevant findings from clinical laboratory tests (haematology, urinalysis, blood chemistry), physical examination, vital signs, and 12-lead ECG. Assessed separately for the healthy-volunteer participants (Part A and B) and the AD participants in Part C.
Measured: From first dose through end of study (up to Week 48 for BYN-001 recipients; up to 2 weeks post-unblinding for placebo recipients)
Secondary outcomes (4)
Pharmacokinetic parameters of BYN-001
Peak plasma concentration of BYN-001 may be calculated if deemed necessary.
Measured: Serial PK sampling per the Schedule of Assessments, through Week 48
Incidence of anti-drug antibodies (ADA) to BYN-001
Immunogenicity assessed using a validated methods.
Measured: Baseline through Week 48
Pharmacokinetic parameters of BYN-001
Area under the curve of BYN-001 may be calculated if deemed necessary.
Measured: Serial PK sampling per the Schedule of Assessments, through Week 48
Titer of anti-drug antibodies (ADA) to BYN-001
Immunogenicity assessed using validated methods.
Measured: Baseline through Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start17 Aug 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bionyra Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746817
- Sponsor's protocol ID
- BYN-001-101
- Acronym
- BYN-001-101
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BYN-001 in Healthy Adult Participants and Participants With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07746817
- Acronym / sponsor ID
- BYN-001-101 / BYN-001-101
- Conditions
- Atopic Dermatitis, Healthy Participants
- Keywords
- IL-25, Monoclonal antibody, First-in-human, Multiple ascending dose, Single ascending dose, Atopic dermatitis, Healthy Participant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Bionyra PharmaIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Aug 2026 (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 first-in-human study evaluates BYN-001, a humanized IgG1 monoclonal antibody targeting interleukin-25 (IL-25), a cytokine implicated in atopic dermatitis. Parts A and B are randomized, double-blind, placebo-controlled single and multiple ascending dose cohorts in healthy adults, that will assess safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of BYN-001. Part C will assess BYN-001 in adults with moderate to severe atopic dermatitis.
Detailed description
Atopic dermatitis (AD) is a common chronic inflammatory skin disease for which current type 2 cytokine-targeted biologics leave a substantial proportion of patients with an inadequate response or residual pruritus. IL-25 acts upstream of type 2 inflammation and has been shown to drive pruritus and epidermal barrier dysfunction. BYN-001 selectively binds and neutralises IL-25 (with a long predicted terminal half-life), supporting an infrequent dosing interval.
Part A will consist of a single ascending dose (SAD) design, with administration in up to five cohorts. Part B will consist of a multiple ascending dose (MAD) design, with administration in up to three cohorts. Both parts will enroll healthy participants and will be conducted under a sentinel dosing approach, with dose escalation decisions governed by a Safety Monitoring Committee (SMC) at each escalation step.
Part C will enroll participants with moderate to severe AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental, Part A, SAD Cohorts: BYN-001 Active drug | Experimental | Biological: BYN-001Healthy participants will receive a single dose of BYN-001 in a dose escalation format |
| Placebo Comparator, Part A, SAD Cohorts Placebo | Placebo comparator | Drug: PlaceboHealthy participants will receive a single dose of placebo comparator |
| Experimental, Part B, MAD Cohorts: BYN-001 Active drug | Experimental | Biological: BYN-001Healthy participants will receive a repeated doses of BYN-001 in a dose escalation format |
| Placebo Comparator Part B, MAD Cohorts: BYN-001 Placebo | Placebo comparator | Drug: PlaceboHealthy participants will receive repeated doses of placebo comparator |
| Experimental, Part C, Participants with mild to severe atopic dermatitis, BYN-001 | Experimental | Biological: BYN-001Participants with mild to severe atopic dermatitis will be randomized to receive repeat doses of BYN-001 |
| Placebo Comparator, Part C, Participants with mild to severe atopic dermatitis, Placebo | Placebo comparator | Drug: PlaceboParticipants with mild to severe atopic dermatitis will be randomized to receive repeat doses of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| BYN-001BYN-001 will be administered by subcutaneous injection. In Part A, a Single Ascending Dose (SAD) design will be implemented across up to five cohorts, with healthy participants receiving a single dose of BYN-001. In Part B, a Multiple Ascending Dose (MAD) design will be implemented with healthy participants receiving multiple doses of BYN-001. | Biological | Experimental, Part A, SAD Cohorts: BYN-001 Active drug, Experimental, Part B, MAD Cohorts: BYN-001 Active drug, Experimental, Part C, Participants with mild to severe atopic dermatitis, BYN-001 |
| PlaceboPart A SAD healthy participants will receive a single subcutaneous injection of placebo. Part B MAD healthy participants will receive multiple doses of subcutaneous injection of placebo. | Drug | Placebo Comparator Part B, MAD Cohorts: BYN-001 Placebo, Placebo Comparator, Part A, SAD Cohorts Placebo, Placebo Comparator, Part C, Participants with mild to severe atopic dermatitis, Placebo |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: From first dose through end of study (up to Week 48 for BYN-001 recipients; up to 2 weeks post-unblinding for placebo recipients)
Includes clinically relevant findings from clinical laboratory tests (haematology, urinalysis, blood chemistry), physical examination, vital signs, and 12-lead ECG. Assessed separately for the healthy-volunteer participants (Part A and B) and the AD participants in Part C.
4 secondary outcomes
Pharmacokinetic parameters of BYN-001
Time frame: Serial PK sampling per the Schedule of Assessments, through Week 48
Incidence of anti-drug antibodies (ADA) to BYN-001
Time frame: Baseline through Week 48
Pharmacokinetic parameters of BYN-001
Time frame: Serial PK sampling per the Schedule of Assessments, through Week 48
Titer of anti-drug antibodies (ADA) to BYN-001
Time frame: Baseline through Week 48
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 30 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 BYN-001 in people with Atopic Dermatitis and Healthy Participants, run by Bionyra Pharma at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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 Australia. 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?
Contact James McCarthy, Prof. (+61 3 9970 4200, jmccarthy@dohertyclinicaltrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: From first dose through end of study (up to Week 48 for BYN-001 recipients; up to 2 weeks post-unblinding for placebo recipients)). 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 30 Sep 2026.