A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants
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.
1 other identifier
interventional
46
1 country
1
Brief Summary
The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Nov 2024
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2024
CompletedFirst Posted
Study publicly available on registry
September 25, 2024
CompletedStudy Start
First participant enrolled
November 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedSeptember 8, 2025
September 1, 2025
7 months
September 23, 2024
September 5, 2025
Conditions
Keywords
Outcome Measures
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
Up to 2700 hours
Secondary Outcomes (2)
Cmax
Up to 2700 hours
AUC0-infinity
Up to 2700 hours
Study Arms (8)
HB0056 dose group 1
ACTIVE COMPARATORHB0056 single dose
HB0056 dose group 2
ACTIVE COMPARATORHB0056 single dose
HB0056 dose group 3
ACTIVE COMPARATORHB0056 single dose
HB0056 dose group 4
ACTIVE COMPARATORHB0056 single dose
HB0056 dose group 5
ACTIVE COMPARATORHB0056 single dose
HB0056 dose group 6
ACTIVE COMPARATORHB0056 single dose
HB0056 dose group 7
ACTIVE COMPARATORHB0056 single dose
Matching placebo for each dose group
PLACEBO COMPARATORplacebo, single dose
Interventions
HB0056 Injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Zealand Clinical Research
Christchurch, 8011, New Zealand
Study Officials
- PRINCIPAL INVESTIGATOR
Cory Sellwood
New Zealand Clinical Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2024
First Posted
September 25, 2024
Study Start
November 18, 2024
Primary Completion
June 13, 2025
Study Completion
October 1, 2025
Last Updated
September 8, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share