A Study to Evaluate HB0034 in Healthy Adult Participants

September 12, 2022 updated by: Shanghai Huaota Biopharmaceutical Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • New Zealand Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HB0034 dose group 1
HB0034 single dose
Drug: HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Other Names:
  • no other invention names
Active Comparator: HB0034 dose group 2
HB0034 single dose
Drug: HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Other Names:
  • no other invention names
Active Comparator: HB0034 dose group 3
HB0034 single dose
Drug: HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Other Names:
  • no other invention names
Active Comparator: HB0034 dose group 4
HB0034 single dose
Drug: HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Other Names:
  • no other invention names
Active Comparator: HB0034 dose group 5
HB0034 single dose
Drug: HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Other Names:
  • no other invention names
Active Comparator: HB0034 dose group 6
HB0034 single dose
Drug: HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Other Names:
  • no other invention names
Active Comparator: HB0034 dose group 7
HB0034 single dose
Drug: HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Other Names:
  • no other invention names
Placebo Comparator: Matching placebo for each dose group
placebo, single dose
Drug: Placebo
Palcebo
Other Names:
  • no other invention names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 2000 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: up to 2000 hours
The maximum measured concentration of the analysis in plasma
up to 2000 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-infinity
Time Frame: up to 2000 hours
The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
up to 2000 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • HB0034-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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