Clinical trial NCT06999083: A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants
Official title: A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0043 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: HB0043
Lead sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-31
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate the safety and tolerability of HB0043 in healthy subjects following single-dose.

Detailed description: This is a single-dose escalation study of HB0043 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0043.

Eligibility criteria: Inclusion Criteria:

* Subjects must meet the following criteria to be eligible for study entry:

  1. Healthy male or female subjects age ≥ 18 and ≤ 55 years.
  2. Men and women of reproductive potential, willing to practice a highly effective method of birth control for the duration of the study and continuing for 6 months after receiving the last dose of drug administration. Highly effective methods of birth control include sexual abstinence (men, women); vasectomy or a condom (men) in combination with other barrier methods, hormonal birth control or IUD (women).
  3. Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m².
  4. No clinically significant findings in the medical history and physical examination.
  5. No clinically significant laboratory values (including urinalysis), unless the investigator considers any abnormality to not be clinically significant.
  6. Normal ECG, blood pressure, respiratory rate, temperature and heart rate, unless the investigator considers any abnormality to be not clinically significant.
  7. Informed consent must be obtained for all subjects enrolled into the study.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from study entry:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease.
2. Current or history of malignancy.
3. Family history of premature Coronary Heart Disease (CHD).
4. Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ. Exposure to any prescription medication 14 days prior to randomization, to herbal remedies or over-the countermedications (except for the occasional use of acetaminophen \[up to 2,000 mg per day\]) 7 days prior to randomization.
5. Participation in another research with any investigational product within 28 days or 5 half-lives of the drug, whichever is greater, before screening.
6. Known allergy to biologics.
7. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing
8. Had a vaccination with a live attenuated vaccine within 1 months prior to dosing.
9. Subjects at risk for tuberculosis (TB), specifically subjects with:

   * Current clinical, radiographic or laboratorial evidence of active TB;
   * Positive interferon-γ release assay (IGRA) test.
10. Positive test at screening for any of the following infectious disease tests: Hepatitis B, surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), Human immunodeficiency virus antibody (HIV Ab).
11. History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
12. A helminth parasitic infection diagnosed within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy.
13. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
14. Presence of fever (body temperature \>37.5°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to the first dosing.
15. History of drug abuse within 1 year prior to screening, or use of soft drugs (such as marijuana) within 3 months prior to the screening, or hard drugs (such as cocaine, phencyclidine, and crack) within 1 year prior to screening. Positive drug screen (cocaine, methamphetamine, phencyclidine, and Tetrahydrocannabinol) at screening or Day -1.
16. History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months before screening. Positive Breath Alcohol Test at screening or Day -1.
17. Current cigarette smoker (cigarettes or e-cigarettes) who smoke over 5 cigarettes/day within 3 months prior to screening.
18. Mental condition rendering the subject incapable of understanding the nature, scope, and possible consequences of the study.
19. Pregnant or Breasting feeding subject. Women with positive pregnancy test (hCG). Or subjects who plan to donate sperms or eggs, from dosing until at least 6 months after last dose of investigational medicine.
20. Adults under guardianship and people with restriction of freedom by administrative and legal decisions.
21. Unlikely to comply with the clinical study protocol, e.g. uncooperative attitude, inability to return for followed-up visit, and improbability of completing the study.
22. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the study.

Primary outcomes:
measure: Percentage of subjects with drug related adverse events (AEs)
timeFrame: Up to 1200 hours
Secondary outcomes:
measure: Cmax
timeFrame: Up to 1200 hours
measure: AUC0-infinity
timeFrame: Up to 1200 hours
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research , Grafton, Auckland, 3 Ferncroft Street,
state: Grafton
Study officials:
affiliation: New Zealand Clinical Research
name: Millie Wang
role: PRINCIPAL_INVESTIGATOR
References: