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Recruiting NCT06612970

A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HB0056, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1a, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0056 in Adult Healthy Subjects.

Overview

The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.

Detailed description

This is a single-dose escalation study of HB0056 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0056.

Interventions

  • Drug HB0056
    HB0056 Injection
  • Drug Placebo
    Placebo

Primary outcome measures

  • Percentage of subjects with drug related adverse events (AEs) [Time frame: Up to 2700 hours]
Secondary outcome measures (2)
  • Cmax [Time frame: Up to 2700 hours]
  • AUC0-infinity [Time frame: Up to 2700 hours]

Eligibility criteria

Inclusion criteria

  • Healthy male or female subjects age ≥ 18 and ≤ 55 years.
  • Body Mass Index (BMI) ≥ 18 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 applied.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Other

Study locations

New Zealand · 1 center
  • New Zealand Clinical Research — Christchurch

Identifiers

NCT: NCT06612970 · HB0056-HV-01-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗