HealthyPhase 1NCT05064345
A Study to Evaluate HB0034 in Healthy Adult Participants
A Phase 1 study testing HB0034 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 HB0034 in healthy subjects following a 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?
- HB0034
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNew Zealand
- Study dates
- 3 Dec 2021to 1 Sep 2022
- 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
- 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 (HCG).
- Further exclusions criteria apply.
Trial locations and contacts
1 site in 1 country.
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 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.
Read the detailed description
This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.
- Conditions
- Healthy
- Being tested
- HB0034, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0034Drug
Also called no other invention names
Recombinant Humanized Anti-IL-36R Monoclonal antibody
PlaceboDrug
Also called no other invention names
Palcebo
| Study group | Role | What they receive |
|---|---|---|
| HB0034 dose group 1 | Active comparator | HB0034 single dose Receives: Drug: HB0034 |
| HB0034 dose group 2 | Active comparator | HB0034 single dose Receives: Drug: HB0034 |
| HB0034 dose group 3 | Active comparator | HB0034 single dose Receives: Drug: HB0034 |
| HB0034 dose group 4 | Active comparator | HB0034 single dose Receives: Drug: HB0034 |
| HB0034 dose group 5 | Active comparator | HB0034 single dose Receives: Drug: HB0034 |
| HB0034 dose group 6 | Active comparator | HB0034 single dose Receives: Drug: HB0034 |
| HB0034 dose group 7 | Active comparator | HB0034 single dose Receives: Drug: HB0034 |
| 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 2000 hours
Secondary outcomes (1)
Cmax
The maximum measured concentration of the analysis in plasma
Measured: up to 2000 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start3 Dec 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Schwabe, Principal investigator, NZCR OpCo limited AKL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064345
- Sponsor's protocol ID
- HB0034-01
- Status last verified
- Nov 2021
- First submitted
- 22 Sep 2021
- Last updated
- 14 Sep 2022
- 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 14 Sep 2022. 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 HB0034 in Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT05064345
- Acronym / sponsor ID
- HB0034-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 1 Oct 2021 (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.
Detailed description
This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HB0034 dose group 1 | Active comparator | Drug: HB0034HB0034 single dose |
| HB0034 dose group 2 | Active comparator | Drug: HB0034HB0034 single dose |
| HB0034 dose group 3 | Active comparator | Drug: HB0034HB0034 single dose |
| HB0034 dose group 4 | Active comparator | Drug: HB0034HB0034 single dose |
| HB0034 dose group 5 | Active comparator | Drug: HB0034HB0034 single dose |
| HB0034 dose group 6 | Active comparator | Drug: HB0034HB0034 single dose |
| HB0034 dose group 7 | Active comparator | Drug: HB0034HB0034 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 (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 (6 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 (HCG).
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 |
|---|---|---|
| HB0034Also: no other invention namesRecombinant Humanized Anti-IL-36R Monoclonal antibody | Drug | HB0034 dose group 1, HB0034 dose group 2, HB0034 dose group 3, HB0034 dose group 4, HB0034 dose group 5, HB0034 dose group 6, HB0034 dose group 7 |
| PlaceboAlso: no other invention namesPalcebo | Drug | Matching placebo for each dose group |
Primary outcome
Percentage of subjects with drug related adverse events (AEs)
Time frame: up to 2000 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
1 secondary outcome
Cmax
Time frame: up to 2000 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 14 Sep 2022.
- 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.
Christian Schwabe principal investigator
NZCR OpCo limited AKL
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 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 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: finished, as of the sponsor's last update on 14 Sep 2022. 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 2000 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 14 Sep 2022.