HealthyPhase 1NCT06716151
A Study to Evaluate HB0034 in Healthy Chinese Adult Participants
A Phase 1 study testing HB0034 in people with Healthy, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HB0034
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2024to 20 Nov 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects age ≥ 18 and ≤ 55 years.
- Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².
- Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
Who cannot join
- 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)
- History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
- Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
- Further exclusion criterias apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Central Hospital affiliated to Shandong First Medical University
Jinan, Shandong
Li Cuigang, +860531-55566416, zxyyywsy@163.com
Qing Wen
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single/mulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult Healthy Subjects
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.
Read the detailed description
This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.
- Conditions
- Healthy
- Being tested
- HB0034, HB0034 matching placebo
- Keywords
- Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0034Drug
Recombinant Humanized Anti-IL-36R Monoclonal antibody
HB0034 matching placeboDrug
HB0034 matching Palcebo
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: HB0034 dose group 1 | Experimental | 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody Receives: Drug: HB0034 |
| Active Comparator: HB0034 dose group 2 | Experimental | 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody Receives: Drug: HB0034 |
| Active Comparator: HB0034 dose group 3 | Experimental | 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody Receives: Drug: HB0034 |
| Active Comparator: HB0034 dose group 4 | Experimental | 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody Receives: Drug: HB0034 |
| Active Comparator: HB0034 dose group 5 | Experimental | 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody Receives: Drug: HB0034 |
| Active Comparator: HB0034 dose group 6 | Experimental | 8 subjects receive a multi-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody Receives: Drug: HB0034 |
| Active Comparator: HB0034 dose group 7 | Experimental | 8 subjects receive a multi-dose of HB0034 a recombinant humanized anti-IL-36R IgG1 monoclonal antibody Receives: Drug: HB0034 |
| Placebo group | Placebo comparator | 17 subjects receive placebo Receives: Drug: HB0034 matching 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 the investigational drug
Measured: up to 113 days
Secondary outcomes (2)
Cmax
The maximum measured concentration of the analysis in plasma
Measured: Up to 113 days
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 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start6 Dec 2024
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716151
- Sponsor's protocol ID
- HB0034-HV-01-03
- Status last verified
- Jan 2025
- First submitted
- 29 Nov 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Single/mulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT06716151
- Acronym / sponsor ID
- HB0034-HV-01-03
- Conditions
- Healthy
- Keywords
- Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 4 Dec 2024 (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 HB0034 in healthy subjects following a single dose or multiple dose.
Detailed description
This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: HB0034 dose group 1 | Experimental | Drug: HB00346 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
| Active Comparator: HB0034 dose group 2 | Experimental | Drug: HB00346 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
| Active Comparator: HB0034 dose group 3 | Experimental | Drug: HB00346 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
| Active Comparator: HB0034 dose group 4 | Experimental | Drug: HB00346 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
| Active Comparator: HB0034 dose group 5 | Experimental | Drug: HB00346 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
| Active Comparator: HB0034 dose group 6 | Experimental | Drug: HB00348 subjects receive a multi-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
| Active Comparator: HB0034 dose group 7 | Experimental | Drug: HB00348 subjects receive a multi-dose of HB0034 a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
| Placebo group | Placebo comparator | Drug: HB0034 matching placebo17 subjects receive placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects age ≥ 18 and ≤ 55 years.
- Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg/m².
- Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
Key exclusion criteria (5 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)
- History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
- Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
- Further exclusion criterias apply.
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 |
|---|---|---|
| HB0034Recombinant Humanized Anti-IL-36R Monoclonal antibody | Drug | Active Comparator: HB0034 dose group 1, Active Comparator: HB0034 dose group 2, Active Comparator: HB0034 dose group 3, Active Comparator: HB0034 dose group 4, Active Comparator: HB0034 dose group 5, Active Comparator: HB0034 dose group 6, Active Comparator: HB0034 dose group 7 |
| HB0034 matching placeboHB0034 matching Palcebo | Drug | Placebo group |
Primary outcome
Percentage of subjects with drug related adverse events (AEs)
Time frame: up to 113 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational drug
2 secondary outcomes
Cmax
Time frame: Up to 113 days
AUC0-infinity
Time frame: up to 113 days
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 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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 HB0034 in people with Healthy, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site in China.
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 5 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 20 Jan 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 China. 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 Yuan Tang (+86 15821321563, yuan.tang@huaota.com), or a site near the patient. 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 113 days). 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 20 Jan 2025.