Healthy VolunteersPhase 1NCT06999720
Study of HX15001 in Adult Healthy Volunteers.
A Phase 1 study testing HX15001 (SAD) and HX15001 (MAD) in people with Healthy Volunteers, run by Helixon Biotechnology (Suzhou) Co., Ltd at 1 site in Australia.
Trial summary
This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult 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?
- HX15001 (SAD) and HX15001 (MAD)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Jun 2025to 30 Sep 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
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
- Have a Body mass index (BMI) of 18-32 kg/m2 , inclusive; with body weight ≥50 kg during the screening.
- In good health, as determined by the investigator at Screening procedures, with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.
- Subjects 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 breastfeeding during the trial.
- Has a positive result of pregnancy test at Screening or Baseline
- History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCV Ab or serological reaction of syphilis
- Subjects at risk for tuberculosis (TB).
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;
- Has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days or 5 half-lives prior to dosing, or plan to receive another experimental agent during the duration of this trial;
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- Subjects who have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days prior to dosing, or those who plan to donate blood during the study period 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) prior to dosing
- Triplicate 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- Has clinically significant interventional therapies (surgery, paracentesis, etc.) within 6 months prior to dosing, or plan to have any surgeries during the duration the trial.
- History of any hypersensitivity or allergic reaction to drugs;
- Has any other conditions that would, in the opinion of the investigator, put the subjects 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
Q-Pharm Pty Ltd.
Herston, Queensland, 4006
Richard Friend, (07) 3707 2720, r.friend@nucleusnetwork.com.au
About this study
Official title: A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Dose and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HX15001 in Adult Healthy Volunteers.
This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants.
The study consists of two parts: Part A involves single-dose escalation (Cohorts 1-7), and Part B involves multiple-dose escalation (Cohorts 8-9).
The primary objective of this study is to characterize the safety and tolerability of single and multiple doses of HX15001 in healthy subjects.
Read the detailed description
This study consists of two parts. Part A: This part includes seven sequential ascending-dose cohorts, designated as Cohorts 1 through 7. Cohort 1 and Cohort 6 will enroll four healthy subjects in each cohort. Cohort 2 will enroll six healthy subjects. The remaining four cohorts will enroll eight healthy subjects each.
On Day 1, after final eligibility has been determined, subjects in Cohorts 1-5 will be randomly assigned to receive a single subcutaneous dose (which may be split into multiple dosing syringes) of HX15001 or placebo, while subjects in Cohorts 6 and 7 will be randomly assigned to receive a single intravenous infusion of HX15001 or placebo. The doses for Cohorts 1-7 will be administered as per the protocol.
Part B: This part consists of two multiple-dose cohorts (Cohorts 8 and 9), each enrolling eight healthy subjects. Subjects in these cohorts will receive subcutaneous doses of HX15001 or placebo on Days 1, 15, and 43. Dosing will be followed by safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments.
Study Period Part A: Screening：Up to 28 days Treatment：Day 1 single dose Follow up: 112 days including Day 1 (Cohort 1-3) 140 days including Day 1 (Cohort 4-7) Part B: Screening：Up to 28 days Treatment：Day 1, Day 15, Day 43 (single dose on each visit) Follow up: 20 weeks (Day 183) The final follow-up visit will be determined based on the safety and PK data derived from the previous SAD and MAD cohorts, which may be earlier or later than Day 183 (±7 days
- Conditions
- Healthy Volunteers
- Being tested
- HX15001 (SAD), Placebo, HX15001 (MAD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX15001 (SAD)Drug
Part A (Single Ascending Dose), participants will receive a single intravenous dose of HX15001 at escalating dose levels in sequential cohorts (Cohorts 1-7).
PlaceboDrug
Participants will receive matching placebo across cohorts 1-7 of the study.
HX15001 (MAD)Drug
In Part B (Multiple Ascending Dose), participants will receive multiple intravenous doses of HX15001 in cohorts 8 and 9 to assess safety, tolerability, and pharmacokinetics.
PlaceboDrug
Participants will receive matching placebo across cohorts 8-9 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Single-Ascending Dose (SAD) | Experimental | Participants will receive a single intravenous dose of HX15001 (Cohort 1-7). Receives: Drug: HX15001 (SAD) |
| Placebo SAD Cohorts (1-7) | Placebo comparator | Participants will receive multiple intravenous dose of Placebo Receives: Drug: Placebo |
| Part B - Multiple Ascending Dose (MAD) | Experimental | Participants will receive multiple intravenous doses of HX15001 (Cohort 8-9). Receives: Drug: HX15001 (MAD) |
| Placebo MAD Cohorts (8-9) | Placebo comparator | Participants will receive multiple intravenous dose of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 1-3
Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)
Measured: Up to day 113
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 4-7
Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)
Measured: Up to day 141
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 8-9
Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)
Measured: Up to day 183
Secondary outcomes (5)
Cmax
Maximum concentration after single and multiple ascending doses
Measured: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)
Tmax
Time to reach maximum concentration after single and multiple ascending doses
Measured: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)
t1/2
Half life after single and multiple ascending doses
Measured: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)
AUC
Area under the curve after single and multiple ascending doses
Measured: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)
ADA
Incidence of anti-drug antibody after single and multiple ascending doses
Measured: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start11 Jun 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 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
- NCT06999720
- Sponsor's protocol ID
- HXN-IMM-001-I
- Status last verified
- Aug 2025
- First submitted
- 22 May 2025
- Last updated
- 24 Aug 2025
- 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Dose and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HX15001 in Adult Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT06999720
- Acronym / sponsor ID
- HXN-IMM-001-I
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Helixon Biotechnology (Suzhou) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 31 May 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 I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants.
The study consists of two parts: Part A involves single-dose escalation (Cohorts 1-7), and Part B involves multiple-dose escalation (Cohorts 8-9).
The primary objective of this study is to characterize the safety and tolerability of single and multiple doses of HX15001 in healthy subjects.
Detailed description
This study consists of two parts. Part A: This part includes seven sequential ascending-dose cohorts, designated as Cohorts 1 through 7. Cohort 1 and Cohort 6 will enroll four healthy subjects in each cohort. Cohort 2 will enroll six healthy subjects. The remaining four cohorts will enroll eight healthy subjects each.
On Day 1, after final eligibility has been determined, subjects in Cohorts 1-5 will be randomly assigned to receive a single subcutaneous dose (which may be split into multiple dosing syringes) of HX15001 or placebo, while subjects in Cohorts 6 and 7 will be randomly assigned to receive a single intravenous infusion of HX15001 or placebo. The doses for Cohorts 1-7 will be administered as per the protocol.
Part B: This part consists of two multiple-dose cohorts (Cohorts 8 and 9), each enrolling eight healthy subjects. Subjects in these cohorts will receive subcutaneous doses of HX15001 or placebo on Days 1, 15, and 43. Dosing will be followed by safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments.
Study Period Part A: Screening：Up to 28 days Treatment：Day 1 single dose Follow up: 112 days including Day 1 (Cohort 1-3) 140 days including Day 1 (Cohort 4-7) Part B: Screening：Up to 28 days Treatment：Day 1, Day 15, Day 43 (single dose on each visit) Follow up: 20 weeks (Day 183) The final follow-up visit will be determined based on the safety and PK data derived from the previous SAD and MAD cohorts, which may be earlier or later than Day 183 (±7 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A - Single-Ascending Dose (SAD) | Experimental | Drug: HX15001 (SAD)Participants will receive a single intravenous dose of HX15001 (Cohort 1-7). |
| Placebo SAD Cohorts (1-7) | Placebo comparator | Drug: PlaceboParticipants will receive multiple intravenous dose of Placebo |
| Part B - Multiple Ascending Dose (MAD) | Experimental | Drug: HX15001 (MAD)Participants will receive multiple intravenous doses of HX15001 (Cohort 8-9). |
| Placebo MAD Cohorts (8-9) | Placebo comparator | Drug: PlaceboParticipants will receive multiple intravenous dose of Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
- Have a Body mass index (BMI) of 18-32 kg/m2 , inclusive; with body weight ≥50 kg during the screening.
- In good health, as determined by the investigator at Screening procedures, with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.
- Subjects must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.
Key exclusion criteria (12 listed)
- Females who are pregnant, planning to become pregnant, or breastfeeding during the trial.
- Has a positive result of pregnancy test at Screening or Baseline
- History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCV Ab or serological reaction of syphilis
- Subjects at risk for tuberculosis (TB).
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;
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 |
|---|---|---|
| HX15001 (SAD)Part A (Single Ascending Dose), participants will receive a single intravenous dose of HX15001 at escalating dose levels in sequential cohorts (Cohorts 1-7). | Drug | Part A - Single-Ascending Dose (SAD) |
| PlaceboParticipants will receive matching placebo across cohorts 1-7 of the study. | Drug | Placebo SAD Cohorts (1-7) |
| HX15001 (MAD)In Part B (Multiple Ascending Dose), participants will receive multiple intravenous doses of HX15001 in cohorts 8 and 9 to assess safety, tolerability, and pharmacokinetics. | Drug | Part B - Multiple Ascending Dose (MAD) |
| PlaceboParticipants will receive matching placebo across cohorts 8-9 of the study. | Drug | Placebo MAD Cohorts (8-9) |
Primary outcome
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 1-3
Time frame: Up to day 113
Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 4-7
Time frame: Up to day 141
Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)
Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 8-9
Time frame: Up to day 183
Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)
5 secondary outcomes
Cmax
Time frame: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)
Tmax
Time frame: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)
t1/2
Time frame: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)
AUC
Time frame: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)
ADA
Time frame: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)
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 Aug 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.
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 HX15001 (SAD) and HX15001 (MAD) in people with Healthy Volunteers, 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 5 inclusion and 12 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 Aug 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 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 (AEs) and Serious Adverse Events (SAEs) cohort 1-3 (time frame: Up to day 113). The study lists 3 primary outcomes in all. 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 Aug 2025.