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
- Phase
- Phase 1
- Intervention
- HB0056
- Conditions
- Healthy
- Sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Percentage of subjects with drug related adverse events (AEs)
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Investigators
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.
Arms & Interventions
HB0056 dose group 1
HB0056 single dose
Intervention: HB0056
HB0056 dose group 2
HB0056 single dose
Intervention: HB0056
HB0056 dose group 3
HB0056 single dose
Intervention: HB0056
HB0056 dose group 4
HB0056 single dose
Intervention: HB0056
HB0056 dose group 5
HB0056 single dose
Intervention: HB0056
HB0056 dose group 6
HB0056 single dose
Intervention: HB0056
HB0056 dose group 7
HB0056 single dose
Intervention: HB0056
Matching placebo for each dose group
placebo, single dose
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of subjects with drug related adverse events (AEs)
Time Frame: Up to 2700 hours
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
Secondary Outcomes
- Cmax(Up to 2700 hours)
- AUC0-infinity(Up to 2700 hours)