A Study to Evaluate HB0034 in Healthy Adult Participants

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05064345

Enrollment

Registered

2021-10-01

Start date

2021-12-03

Completion date

2022-09-01

Last updated

2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGHB0034

Recombinant Humanized Anti-IL-36R Monoclonal antibody

DRUGPlacebo

Palcebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of subjects with drug related adverse events (AEs)	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

Secondary

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

Other

Measure	Time frame	Description
AUC0-infinity	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

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026