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
1 other identifier
interventional
56
1 country
1
Brief Summary
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Dec 2021
Typical duration 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
October 1, 2021
CompletedStudy Start
First participant enrolled
December 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedSeptember 14, 2022
November 1, 2021
9 months
September 22, 2021
September 12, 2022
Conditions
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 2000 hours
Secondary Outcomes (1)
Cmax
up to 2000 hours
Other Outcomes (1)
AUC0-infinity
up to 2000 hours
Study Arms (8)
HB0034 dose group 1
ACTIVE COMPARATORHB0034 single dose
HB0034 dose group 2
ACTIVE COMPARATORHB0034 single dose
HB0034 dose group 3
ACTIVE COMPARATORHB0034 single dose
HB0034 dose group 4
ACTIVE COMPARATORHB0034 single dose
HB0034 dose group 5
ACTIVE COMPARATORHB0034 single dose
HB0034 dose group 6
ACTIVE COMPARATORHB0034 single dose
HB0034 dose group 7
ACTIVE COMPARATORHB0034 single dose
Matching placebo for each dose group
PLACEBO COMPARATORplacebo, single dose
Interventions
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Eligibility Criteria
You may qualify if:
- 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.
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 (HCG).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New zealand Clinical Research
Auckland, New Zealand
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Schwabe
NZCR OpCo limited AKL
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2021
First Posted
October 1, 2021
Study Start
December 3, 2021
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
September 14, 2022
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share