A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-13

Study Completion Date

2023-12-08

Brief Summary

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The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following multiple-dose.

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Detailed Description

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This is a multi-dose escalation study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HB0034 dose group 1

8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo

Group Type ACTIVE_COMPARATOR

Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo

Intervention Type DRUG

HB0034 and Placebo

HB0034 dose group 2

8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo

Group Type ACTIVE_COMPARATOR

Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo

Intervention Type DRUG

HB0034 and Placebo

HB0034 dose group 3

8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo

Group Type ACTIVE_COMPARATOR

Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo

Intervention Type DRUG

HB0034 and Placebo

Interventions

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Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo

HB0034 and Placebo

Intervention Type DRUG

Other Intervention Names

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no other names

Eligibility Criteria

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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 .
* Further exclusions criteria apply.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes