A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants
A Phase Ic, Randomized, Double-blind, Placebo-controlled, Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0034 in Adult Healthy Subjects.
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following multiple-dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Oct 2022
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
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 15, 2022
CompletedStudy Start
First participant enrolled
October 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2023
CompletedJanuary 23, 2024
January 1, 2024
8 months
July 13, 2022
January 21, 2024
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 (2)
Cmax
up to 2000 hours
AUC0-infinity
up to 2000 hours
Study Arms (3)
HB0034 dose group 1
ACTIVE COMPARATOR8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo
HB0034 dose group 2
ACTIVE COMPARATOR8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo
HB0034 dose group 3
ACTIVE COMPARATOR8 subjects receive a multi-dose of HB0034 and 2 subjects receive a multi-dose placebo
Interventions
HB0034 and Placebo
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 .
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
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 15, 2022
Study Start
October 13, 2022
Primary Completion
June 9, 2023
Study Completion
December 8, 2023
Last Updated
January 23, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share