Health AdultsPhase 1NCT07900568
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
A Phase 1 study testing HXN-1013 in people with Health Adults and Asthma, run by Helixon Biotechnology (Suzhou) Co., Ltd at 1 site in Australia.
Trial summary
This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study evaluating HXN-1013 in healthy participants and participants with mild-to-moderate asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adults, Asthma
- What is being tested?
- HXN-1013
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Dec 2026to 30 May 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
Who may be able to join
- Participants must be able to understand and comply with the study requirements and voluntarily sign the informed consent form (ICF).
- (Healthy participants) Male or female aged 18 to 55 years (inclusive) at signing of the ICF.
- (Healthy participants) Male participants weighing ≥ 50.0 kg or and female participants ≥ 45.0 kg, with a body mass index (BMI) between 18.0-32.0 kg/m² (inclusive).
- (Participants with asthma) Participants must have documented physician-diagnosed asthma for ≥12 months, pre-bronchodilator FEV1 ≥60% predicted, objective evidence of variable airflow limitation, and well-controlled disease (GINA) on permitted stable background therapy.
Who cannot join
- Pregnant or breastfeeding women; women planning pregnancy within 180 days after dosing.
- Active or suspected infection within 30 days prior to randomization; positive IGRA indicative of active tuberculosis; positive HIV, syphilis, HBsAg, or HCV antibody.
- History of malignancy within 5 years (except resected basal/squamous cell carcinoma of the skin).
- History of clinically significant hypersensitivity reactions (e.g., anaphylaxis, angioedema) to biologic agents or to study drug excipients.
- Use of therapeutic antibodies within 5 half-lives prior to dosing; experimental agent within 30 days or 5 half-lives; live vaccines within 30 days or non-live vaccines within 14 days.
- Clinically significant ECG abnormalities (e.g., QTcF ≥450 ms male / ≥470 ms female).
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
Veritus Research
Bayswater, Victoria, 3153
Emir Redzepagic, 03 8736 1758 ext. 0494 062 402, info@veritusresearch.com
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HXN-1013 Following Subcutaneous Administration in Healthy Participants and Participants With Mild-to-Moderate Asthma
This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study evaluating HXN-1013 in healthy participants and participants with mild-to-moderate asthma.
Read the detailed description
This study consists of four sequential single ascending dose (SAD) cohorts in healthy participants (Cohorts 1-4) and one separate cohort in participants with mild-to-moderate asthma (Cohort 5).
Approximately eight participants will be enrolled per cohort, with an overall allocation ratio of HXN-1013 to placebo of 6:2. A Safety Review Committee (SRC) will review accumulated safety, PK, and PD data before dose escalation to the next cohort. Cohort 5 (participants with asthma) will be conducted at a dose already evaluated in healthy participants.
HXN-1013 or placebo will be administered as a single subcutaneous injection on Day 1. Participants will be followed for safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity up to Day 141 (±7 days). HXN-1013 is a recombinant humanized bispecific antibody simultaneously targeting thymic stromal lymphopoietin (TSLP) and interleukin-33 (IL-33).
- Conditions
- Health Adults, Asthma
- Being tested
- HXN-1013, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HXN-1013Drug
Participants will receive a single subcutaneous dose of HXN-1013.
PlaceboDrug
Participants will receive a single subcutaneous dose of placebo.
| Study group | Role | What they receive |
|---|---|---|
| HXN-1013 (Healthy Participant) | Experimental | Healthy participants. Receives: Drug: HXN-1013 |
| Placebo (Healthy Participant) | Placebo comparator | Healthy participants. Receives: Drug: Placebo |
| HXN-1013 (Asthma) | Experimental | Participants with asthma. Receives: Drug: HXN-1013 |
| Placebo (Asthma) | Placebo comparator | Participants with asthma. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence, severity, and causal relationship of Adverse Events (AEs)
Measured: Up to day 141
Secondary outcomes (4)
Maximum Observed Plasma Concentration (Cmax)
The maximum (peak) observed drug concentration in plasma after administration.
Measured: Up to day 141
Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t)
Area under the plasma concentration-time curve from time 0 (pre-dose) to the time of the last measurable (quantifiable) plasma concentration.
Measured: Up to day 141
Time to Maximum Concentration (Tmax)
Time to reach peak serum concentration
Measured: Up to day 141
Incidence of anti-drug antibodies (ADA) against HXN-1013
Incidence of treatment-emergent ADA in serum samples
Measured: Up to day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion15 Feb 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AdultsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helixon Biotechnology (Suzhou) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900568
- Sponsor's protocol ID
- HXN-1013-A1-101
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HXN-1013 Following Subcutaneous Administration in Healthy Participants and Participants With Mild-to-Moderate Asthma
- ClinicalTrials.gov ID
- NCT07900568
- Acronym / sponsor ID
- HXN-1013-A1-101
- Conditions
- Health Adults, Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helixon Biotechnology (Suzhou) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 28 Oct 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 is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study evaluating HXN-1013 in healthy participants and participants with mild-to-moderate asthma.
Detailed description
This study consists of four sequential single ascending dose (SAD) cohorts in healthy participants (Cohorts 1-4) and one separate cohort in participants with mild-to-moderate asthma (Cohort 5).
Approximately eight participants will be enrolled per cohort, with an overall allocation ratio of HXN-1013 to placebo of 6:2. A Safety Review Committee (SRC) will review accumulated safety, PK, and PD data before dose escalation to the next cohort. Cohort 5 (participants with asthma) will be conducted at a dose already evaluated in healthy participants.
HXN-1013 or placebo will be administered as a single subcutaneous injection on Day 1. Participants will be followed for safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity up to Day 141 (±7 days). HXN-1013 is a recombinant humanized bispecific antibody simultaneously targeting thymic stromal lymphopoietin (TSLP) and interleukin-33 (IL-33).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HXN-1013 (Healthy Participant) | Experimental | Drug: HXN-1013Healthy participants. |
| Placebo (Healthy Participant) | Placebo comparator | Drug: PlaceboHealthy participants. |
| HXN-1013 (Asthma) | Experimental | Drug: HXN-1013Participants with asthma. |
| Placebo (Asthma) | Placebo comparator | Drug: PlaceboParticipants with asthma. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must be able to understand and comply with the study requirements and voluntarily sign the informed consent form (ICF).
- (Healthy participants) Male or female aged 18 to 55 years (inclusive) at signing of the ICF.
- (Healthy participants) Male participants weighing ≥ 50.0 kg or and female participants ≥ 45.0 kg, with a body mass index (BMI) between 18.0-32.0 kg/m² (inclusive).
- (Participants with asthma) Participants must have documented physician-diagnosed asthma for ≥12 months, pre-bronchodilator FEV1 ≥60% predicted, objective evidence of variable airflow limitation, and well-controlled disease (GINA) on permitted stable background therapy.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women; women planning pregnancy within 180 days after dosing.
- Active or suspected infection within 30 days prior to randomization; positive IGRA indicative of active tuberculosis; positive HIV, syphilis, HBsAg, or HCV antibody.
- History of malignancy within 5 years (except resected basal/squamous cell carcinoma of the skin).
- History of clinically significant hypersensitivity reactions (e.g., anaphylaxis, angioedema) to biologic agents or to study drug excipients.
- Use of therapeutic antibodies within 5 half-lives prior to dosing; experimental agent within 30 days or 5 half-lives; live vaccines within 30 days or non-live vaccines within 14 days.
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 |
|---|---|---|
| HXN-1013Participants will receive a single subcutaneous dose of HXN-1013. | Drug | HXN-1013 (Asthma), HXN-1013 (Healthy Participant) |
| PlaceboParticipants will receive a single subcutaneous dose of placebo. | Drug | Placebo (Asthma), Placebo (Healthy Participant) |
Primary outcome
Adverse events
Time frame: Up to day 141
Incidence, severity, and causal relationship of Adverse Events (AEs)
4 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to day 141
Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t)
Time frame: Up to day 141
Time to Maximum Concentration (Tmax)
Time frame: Up to day 141
Incidence of anti-drug antibodies (ADA) against HXN-1013
Time frame: Up to day 141
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 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Health Adults
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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 HXN-1013 in people with Health Adults and Asthma, run by Helixon Biotechnology (Suzhou) Co., Ltd 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?
The sponsor lists 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 28 Oct 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 Tong Gang (+86 13918569690, tonggang@helixon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Up to day 141). 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 28 Oct 2026.