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CompletedNCT05064345Updated Sep 14, 2022

A Study to Evaluate HB0034 in Healthy Adult Participants

A Phase 1 interventional study of HB0034 and Placebo in Healthy, sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd.. Completed at 1 site in New Zealand. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-14.

Sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd. is the lead sponsor of 16 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    HB0034 dose group 1

    HB0034 single dose

    Drug: HB0034

  • Active comparator
    HB0034 dose group 2

    HB0034 single dose

    Drug: HB0034

  • Active comparator
    HB0034 dose group 3

    HB0034 single dose

    Drug: HB0034

  • Active comparator
    HB0034 dose group 4

    HB0034 single dose

    Drug: HB0034

  • Active comparator
    HB0034 dose group 5

    HB0034 single dose

    Drug: HB0034

  • Active comparator
    HB0034 dose group 6

    HB0034 single dose

    Drug: HB0034

  • Active comparator
    HB0034 dose group 7

    HB0034 single dose

    Drug: HB0034

  • Placebo comparator
    Matching placebo for each dose group

    placebo, single dose

    Drug: Placebo

Interventions

  • DrugHB0034

    Recombinant Humanized Anti-IL-36R Monoclonal antibody

    Also known as: no other invention names

  • DrugPlacebo

    Palcebo

    Also known as: no other invention names

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 2000 hours

Secondary outcomes

  1. Cmax

    The maximum measured concentration of the analysis in plasma

    Time frame: up to 2000 hours

Other outcomes

  1. AUC0-infinity

    The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity

    Time frame: up to 2000 hours

07

Study locations

1 site
  • New zealand Clinical Research
    Auckland, New Zealand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05064345
Lead sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 1, 2021
Start date
Dec 3, 2021
Primary completion
Sep 1, 2022
Completion
Sep 1, 2022
Last update
Sep 14, 2022

Study contacts

Christian Schwabe
principal investigator · NZCR OpCo limited AKL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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