A Study to Evaluate HB0034 in Healthy Chinese Adult Participants
A Phase I, Randomized, Double-blind, Placebo-controlled, Single/mulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult Healthy Subjects
1 other identifier
interventional
60
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 or multiple 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 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
November 29, 2024
CompletedFirst Posted
Study publicly available on registry
December 4, 2024
CompletedStudy Start
First participant enrolled
December 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2025
CompletedJanuary 20, 2025
January 1, 2025
12 months
November 29, 2024
January 16, 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 the investigational drug
up to 113 days
Secondary Outcomes (2)
Cmax
Up to 113 days
AUC0-infinity
up to 113 days
Study Arms (8)
Active Comparator: HB0034 dose group 1
EXPERIMENTAL6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 2
EXPERIMENTAL6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 3
EXPERIMENTAL6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 4
EXPERIMENTAL6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 5
EXPERIMENTAL6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 6
EXPERIMENTAL8 subjects receive a multi-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Active Comparator: HB0034 dose group 7
EXPERIMENTAL8 subjects receive a multi-dose of HB0034 a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Placebo group
PLACEBO COMPARATOR17 subjects receive placebo
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Hospital affiliated to Shandong First Medical University
Jinan, Shandong, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2024
First Posted
December 4, 2024
Study Start
December 6, 2024
Primary Completion
November 20, 2025
Study Completion
November 20, 2025
Last Updated
January 20, 2025
Record last verified: 2025-01