Healthy Volunteers (HV)Phase 1NCT07449741
Phase I Study of HXN6005 in Adult Healthy Participants
A Phase 1 study testing HXN6005 in people with Healthy Volunteers (HV), run by Helixon Biotechnology (Suzhou) Co., Ltd at 1 site in Australia.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HXN6005 in Healthy Participants. Researchers will compare HXN6005 to a placebo (a look-alike substance that contains no drug). 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 (HV)
- What is being tested?
- HXN6005
- 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 siteAustralia
- Study dates
- 27 Apr 2026to 13 Mar 2027
- 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 sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedure.
- Male and female participants aged between 18 to 55 years, inclusive.
- Participants must have a body mass index between 18 to 35 kg/m2, inclusive.
- Healthy participants, in the opinion of the Investigator and as determined by medical history, with normal or clinically acceptable physical examination, clinical laboratory tests and ECG results at Screening and before randomization.
- Female participants must be postmenopausal, surgically sterile, or, if of childbearing potential, agree to use highly effective contraception combined with a condom from screening until 180 days post-dose, and refrain from egg donation or in vitro fertilization during this period.
- Male participants, with their female partner of childbearing potential, agree to use a condom as well as highly effective contraception, and refrain from sperm donation and in vitro fertilization until 180 days after the dosing of the study drug.
- Participants must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.
Who cannot join
- Females who are pregnant, planning to become pregnant, or lactating during the trial;
- History of febrile illness or evidence of any active or suspected infection within 30 days before randomization;
- Participant at risk for tuberculosis;
- History of malignancy within 5 years before randomization, except for non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been successfully treated/excised for more than 12 months;
- Have known type I/II diabetes;
- Positive for human immunodeficiency virus antibodies, syphilis antibodies, hepatitis B surface antigen, or hepatitis C antibodies;
Show all 18Show fewer
- Positive for drugs use before randomization;
- Have used nicotine or tobacco containing products within 3 months prior to dosing, or unwilling to abstain from the use of tobacco or nicotine containing products during confinement in the CRU;
- Have a history of alcohol abuse (alcohol consumption in excess of 14 units per week (1 unit contains 14g alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) in the past one year before randomization, or unwilling to abstain from alcohol for 48 hours prior to admission to the CRU;
- Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days or 5 half-lives before randomization, or plan to receive another experimental agent during the trial;
- Known exposure to any type of antibody or anti-TSLP therapy within 5 half-lives before randomization;
- Have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days before randomization, or those who plan to donate blood during the trial or within 30 days after the end of the study;
- Use of prescription or over-the-counter drugs or dietary or herbal supplements within 7 days or 5 half-lives (whichever is longer) before randomization;
- Recent exposure to live vaccines within 30 days, or non-live vaccines (including mRNA COVID/flu) within 2 weeks before randomization, or plan to receive vaccines during the trial;
- Participants with herpes zoster reactivation or cytomegalovirus that resolved within 60 days before randomization;
- Have clinically significant interventional therapies (surgery, paracentesis, etc.) within 6 months before randomization, or plan to have any surgeries during the trial;
- History of clinically significant hypersensitivity reactions to biologic agents, therapeutic proteins, or to specific excipients relevant to the study drug formulation.
- Have any other conditions that would, in the opinion of the investigator, put the participants at increased risk for participation in this trial.
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
Veritus Research
Bayswater, Victoria, 3153
Veritus Research, 03 8736 1758, info@veritusresearch.com
Emir Redzepagic, Dr.
About this study
Official title: A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HXN6005 in Healthy Participants
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HXN6005 in Healthy Participants.
Researchers will compare HXN6005 to a placebo (a look-alike substance that contains no drug).
Participants will take a single dose of HXN6005 or placebo on Day 1, and visit the clinic for followup and tests per the protocol scheme.
Read the detailed description
This study consists of 4 Cohorts, including three sequential ascending-dose cohorts (Cohort 1,2 and 4), and one paralleled cohorts (Cohort 3).
The investigator and participants will be blinded to treatment assignment. Participants in different dose groups will be enrolled from the low-dose group to the high-dose group.
Eight healthy participants will be randomly enrolled per cohort. In cohort 1,2 and 4 there will be a sentinel group comprising two participants who will be randomized in a 1:1 ratio to receive either HXN6005 or placebo. In Cohort 3, eight participants will be randomized in a 6:2 ratio to receive HXN6005 or placebo.
Following dosing on Day 1, blood samples will be collected according to the protocol. Participants in Cohorts 1-4 will be followed up to Day 141. The final follow-up visit will be determined based on the safety and PK data derived from the previous single ascending dose (SAD) cohorts, which may be earlier or later than Day 141 (±7 days).
- Conditions
- Healthy Volunteers (HV)
- Being tested
- HXN6005, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HXN6005Drug
participants will receive a single subcutaneous dose of HXN6005 at escalating dose levels in Cohort 1-4,
PlaceboDrug
Participants will receive matching placebo across cohorts 1-4 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Single-Ascending Dose (SAD) of HXN6005 | Experimental | Participants will receive a single dose of HXN6005 (Cohort 1-4) Receives: Drug: HXN6005 |
| Single-Ascending Dose (SAD) of placebo | Placebo comparator | Participants will receive single dose of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Day 141
Secondary outcomes (5)
Cmax
Maximum concentration after single ascending dose
Measured: Up to Day 141
Tmax
Time to reach maximum concentration after single ascending dose
Measured: Up to Day 141
t1/2
Half life after single ascending dose
Measured: Up to Day 141
AUC
Area under the concentration-time curve after single ascending dose
Measured: Up to Day 141
ADA
Incidence of anti-drug antibody after single ascending dose
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 posted4 Mar 2026
- Study start27 Apr 2026 (estimated)
- Primary completion13 Mar 2027 (estimated)
- Study completion13 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (HV)Studies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT07449741
- Sponsor's protocol ID
- HXN6005-A1-101
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 24 Apr 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HXN6005 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07449741
- Acronym / sponsor ID
- HXN6005-A1-101
- Conditions
- Healthy Volunteers (HV)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Helixon Biotechnology (Suzhou) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2026 (estimated)
- Primary completion
- 13 Mar 2027 (estimated)
- Study completion
- 13 Mar 2027 (estimated)
- First posted
- 4 Mar 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.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HXN6005 in Healthy Participants.
Researchers will compare HXN6005 to a placebo (a look-alike substance that contains no drug).
Participants will take a single dose of HXN6005 or placebo on Day 1, and visit the clinic for followup and tests per the protocol scheme.
Detailed description
This study consists of 4 Cohorts, including three sequential ascending-dose cohorts (Cohort 1,2 and 4), and one paralleled cohorts (Cohort 3).
The investigator and participants will be blinded to treatment assignment. Participants in different dose groups will be enrolled from the low-dose group to the high-dose group.
Eight healthy participants will be randomly enrolled per cohort. In cohort 1,2 and 4 there will be a sentinel group comprising two participants who will be randomized in a 1:1 ratio to receive either HXN6005 or placebo. In Cohort 3, eight participants will be randomized in a 6:2 ratio to receive HXN6005 or placebo.
Following dosing on Day 1, blood samples will be collected according to the protocol. Participants in Cohorts 1-4 will be followed up to Day 141. The final follow-up visit will be determined based on the safety and PK data derived from the previous single ascending dose (SAD) cohorts, which may be earlier or later than Day 141 (±7 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Ascending Dose (SAD) of HXN6005 | Experimental | Drug: HXN6005Participants will receive a single dose of HXN6005 (Cohort 1-4) |
| Single-Ascending Dose (SAD) of placebo | Placebo comparator | Drug: PlaceboParticipants will receive single dose of Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedure.
- Male and female participants aged between 18 to 55 years, inclusive.
- Participants must have a body mass index between 18 to 35 kg/m2, inclusive.
- Healthy participants, in the opinion of the Investigator and as determined by medical history, with normal or clinically acceptable physical examination, clinical laboratory tests and ECG results at Screening and before randomization.
- Female participants must be postmenopausal, surgically sterile, or, if of childbearing potential, agree to use highly effective contraception combined with a condom from screening until 180 days post-dose, and refrain from egg donation or in vitro fertilization during this period.
Key exclusion criteria (18 listed)
- Females who are pregnant, planning to become pregnant, or lactating during the trial;
- History of febrile illness or evidence of any active or suspected infection within 30 days before randomization;
- Participant at risk for tuberculosis;
- History of malignancy within 5 years before randomization, except for non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been successfully treated/excised for more than 12 months;
- Have known type I/II diabetes;
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 |
|---|---|---|
| HXN6005participants will receive a single subcutaneous dose of HXN6005 at escalating dose levels in Cohort 1-4, | Drug | Single-Ascending Dose (SAD) of HXN6005 |
| PlaceboParticipants will receive matching placebo across cohorts 1-4 of the study. | Drug | Single-Ascending Dose (SAD) of placebo |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Up to Day 141
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
5 secondary outcomes
Cmax
Time frame: Up to Day 141
Tmax
Time frame: Up to Day 141
t1/2
Time frame: Up to Day 141
AUC
Time frame: Up to Day 141
ADA
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 24 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers (HV)
RecruitingObservational study
Imaging Techniques in MRI
Cardiac Risk Factors, Healthy
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
RecruitingObservational study
Defining the Brain Phenotype of Children With Williams Syndrome
Williams Syndrome, Duplication
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 HXN6005 in people with Healthy Volunteers (HV), 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 7 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 24 Apr 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 Gang Tong ((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?
Number of Participants Experiencing 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 24 Apr 2026.