HealthyPhase 1NCT06999083
A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants
A Phase 1 study testing HB0043 in people with Healthy, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site in New Zealand.
Trial summary
The aim of this study is to investigate the safety and tolerability of HB0043 in healthy subjects following single-dose. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HB0043
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteNew Zealand
- Study dates
- 3 Jun 2025to 30 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subjects must meet the following criteria to be eligible for study entry:
- Healthy male or female subjects age ≥ 18 and ≤ 55 years.
- Men and women of reproductive potential, willing to practice a highly effective method of birth control for the duration of the study and continuing for 6 months after receiving the last dose of drug administration. Highly effective methods of birth control include sexual abstinence (men, women); vasectomy or a condom (men) in combination with other barrier methods, hormonal birth control or IUD (women).
- Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m².
- No clinically significant findings in the medical history and physical examination.
- No clinically significant laboratory values (including urinalysis), unless the investigator considers any abnormality to not be clinically significant.
- Normal ECG, blood pressure, respiratory rate, temperature and heart rate, unless the investigator considers any abnormality to be not clinically significant.
- Informed consent must be obtained for all subjects enrolled into the study.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from study entry:
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease.
- Current or history of malignancy.
- Family history of premature Coronary Heart Disease (CHD).
- Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ. Exposure to any prescription medication 14 days prior to randomization, to herbal remedies or over-the countermedications (except for the occasional use of acetaminophen [up to 2,000 mg per day]) 7 days prior to randomization.
- Participation in another research with any investigational product within 28 days or 5 half-lives of the drug, whichever is greater, before screening.
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- Known allergy to biologics.
- Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing
- Had a vaccination with a live attenuated vaccine within 1 months prior to dosing.
- Subjects at risk for tuberculosis (TB), specifically subjects with:
- Current clinical, radiographic or laboratorial evidence of active TB;
- Positive interferon-γ release assay (IGRA) test.
- Positive test at screening for any of the following infectious disease tests: Hepatitis B, surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), Human immunodeficiency virus antibody (HIV Ab).
- History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
- A helminth parasitic infection diagnosed within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy.
- Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
- Presence of fever (body temperature >37.5°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to the first dosing.
- History of drug abuse within 1 year prior to screening, or use of soft drugs (such as marijuana) within 3 months prior to the screening, or hard drugs (such as cocaine, phencyclidine, and crack) within 1 year prior to screening. Positive drug screen (cocaine, methamphetamine, phencyclidine, and Tetrahydrocannabinol) at screening or Day -1.
- History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening. Positive Breath Alcohol Test at screening or Day -1.
- Current cigarette smoker (cigarettes or e-cigarettes) who smoke over 5 cigarettes/day within 3 months prior to screening.
- Mental condition rendering the subject incapable of understanding the nature, scope, and possible consequences of the study.
- Pregnant or Breasting feeding subject. Women with positive pregnancy test (hCG). Or subjects who plan to donate sperms or eggs, from dosing until at least 6 months after last dose of investigational medicine.
- Adults under guardianship and people with restriction of freedom by administrative and legal decisions.
- Unlikely to comply with the clinical study protocol, e.g. uncooperative attitude, inability to return for followed-up visit, and improbability of completing the study.
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the study.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
New Zealand Clinical Research , Grafton, Auckland, 3 Ferncroft Street,
Auckland, Grafton
About this study
Official title: A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0043 in Healthy Adult Subjects
The aim of this study is to investigate the safety and tolerability of HB0043 in healthy subjects following single-dose.
Read the detailed description
This is a single-dose escalation study of HB0043 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0043.
- Conditions
- Healthy
- Being tested
- HB0043, Placebo
- Keywords
- HB0043
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0043Drug
Also called recombinant humanized IgG1 bispecific antibody targeting both IL-17A and IL-36R.
HB0043 Drug Product
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HB0043 dose group 1 | Active comparator | HB0043 single dose Receives: Drug: HB0043 |
| HB0043 dose group 2 | Active comparator | HB0043 single dose Receives: Drug: HB0043 |
| HB0043 dose group 3 | Active comparator | HB0043 single dose Receives: Drug: HB0043 |
| HB0043 dose group 4 | Active comparator | HB0043 single dose Receives: Drug: HB0043 |
| HB0043 dose group 5 | Active comparator | HB0043 single dose Receives: Drug: HB0043 |
| HB0043 dose group 6 | Active comparator | HB0043 single dose Receives: Drug: HB0043 |
| Matching placebo for each dose group | Placebo comparator | placebo, single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with drug related adverse events (AEs)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
Measured: Up to 1200 hours
Secondary outcomes (2)
Cmax
The maximum measured concentration of the analysis in plasma.
Measured: Up to 1200 hours
AUC0-infinity
The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
Measured: Up to 1200 hours
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 start3 Jun 2025
- Primary completion12 Feb 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Shanghai Huaota Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Millie Wang, Principal investigator, New Zealand Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999083
- Sponsor's protocol ID
- HB0043-HV-01-01
- Status last verified
- Jun 2026
- First submitted
- 23 May 2025
- Last updated
- 17 Jun 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0043 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06999083
- Acronym / sponsor ID
- HB0043-HV-01-01
- Conditions
- Healthy
- Keywords
- HB0043
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- 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.
The aim of this study is to investigate the safety and tolerability of HB0043 in healthy subjects following single-dose.
Detailed description
This is a single-dose escalation study of HB0043 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0043.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| HB0043 dose group 1 | Active comparator | Drug: HB0043HB0043 single dose |
| HB0043 dose group 2 | Active comparator | Drug: HB0043HB0043 single dose |
| HB0043 dose group 3 | Active comparator | Drug: HB0043HB0043 single dose |
| HB0043 dose group 4 | Active comparator | Drug: HB0043HB0043 single dose |
| HB0043 dose group 5 | Active comparator | Drug: HB0043HB0043 single dose |
| HB0043 dose group 6 | Active comparator | Drug: HB0043HB0043 single dose |
| Matching placebo for each dose group | Placebo comparator | Drug: Placeboplacebo, single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects must meet the following criteria to be eligible for study entry:
Key exclusion criteria (25 listed)
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease.
- Current or history of malignancy.
- Family history of premature Coronary Heart Disease (CHD).
- Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ. Exposure to any prescription medication 14 days prior to randomization, to herbal remedies or over-the countermedications (except for the occasional use of acetaminophen [up to 2,000 mg per day]) 7 days prior to randomization.
- Participation in another research with any investigational product within 28 days or 5 half-lives of the drug, whichever is greater, before screening.
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 |
|---|---|---|
| HB0043Also: recombinant humanized IgG1 bispecific antibody targeting both IL-17A and IL-36R.HB0043 Drug Product | Drug | HB0043 dose group 1, HB0043 dose group 2, HB0043 dose group 3, HB0043 dose group 4, HB0043 dose group 5, HB0043 dose group 6 |
| PlaceboPlacebo | Drug | Matching placebo for each dose group |
Primary outcome
Percentage of subjects with drug related adverse events (AEs)
Time frame: Up to 1200 hours
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
2 secondary outcomes
Cmax
Time frame: Up to 1200 hours
AUC0-infinity
Time frame: Up to 1200 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 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. This study is not recruiting at the moment.
Millie Wang principal investigator
New Zealand Clinical Research
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 HB0043 in people with Healthy, run by Shanghai Huaota Biopharmaceutical Co., Ltd. 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 8 inclusion and 25 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: finished, as of the sponsor's last update on 17 Jun 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of subjects with drug related adverse events (AEs) (time frame: Up to 1200 hours). 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 17 Jun 2026.