A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants

NCT06999083 | Recruiting Phase 1

• 1 other identifier: HB0043-HV-01-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

HB0043

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 1200 hours

Secondary Outcomes (2)

• Cmax

  Up to 1200 hours

• AUC0-infinity

  Up to 1200 hours

Study Arms (7)

HB0043 dose group 1

ACTIVE COMPARATOR

HB0043 single dose

Drug: HB0043

HB0043 dose group 2

ACTIVE COMPARATOR

HB0043 single dose

Drug: HB0043

HB0043 dose group 3

ACTIVE COMPARATOR

HB0043 single dose

Drug: HB0043

HB0043 dose group 4

ACTIVE COMPARATOR

HB0043 single dose

Drug: HB0043

HB0043 dose group 5

ACTIVE COMPARATOR

HB0043 single dose

Drug: HB0043

HB0043 dose group 6

ACTIVE COMPARATOR

HB0043 single dose

Drug: HB0043

Matching placebo for each dose group

PLACEBO COMPARATOR

placebo, single dose

Drug: Placebo

Interventions

HB0043 DRUG

HB0043 Drug Product

Also known as: recombinant humanized IgG1 bispecific antibody targeting both IL-17A and IL-36R.

HB0043 dose group 1; HB0043 dose group 2; HB0043 dose group 3; HB0043 dose group 4; HB0043 dose group 5; HB0043 dose group 6

Placebo DRUG

Placebo

Matching placebo for each dose group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet the following criteria to be eligible for study entry:
• Healthy male or female subjects age ≥ 18 and ≤ 55 years.
• 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).
• Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m².
• No clinically significant findings in the medical history and physical examination.
• No clinically significant laboratory values (including urinalysis), unless the investigator considers any abnormality to not be clinically significant.
• Normal ECG, blood pressure, respiratory rate, temperature and heart rate, unless the investigator considers any abnormality to be not clinically significant.
• Informed consent must be obtained for all subjects enrolled into the study.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from study entry:
• 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).
• 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.
• Participation in another research with any investigational product within 28 days or 5 half-lives of the drug, whichever is greater, before screening.
• Known allergy to biologics.
• 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
• Had a vaccination with a live attenuated vaccine within 1 months prior to dosing.
• 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.
• 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).
• History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
• 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.

Sponsors & Collaborators

• Shanghai Huaota Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

New Zealand Clinical Research , Grafton, Auckland, 3 Ferncroft Street,

Auckland, Grafton, New Zealand

RECRUITING

MeSH Terms

Interventions

Interleukin-1 Receptor Accessory Protein

Intervention Hierarchy (Ancestors)

Receptors, Interleukin-1; Receptors, Interleukin; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Millie Wang

  New Zealand Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xuewen Gan

CONTACT

086 17384481068; xuewen.gan@huaota.com

xueqiong wu

CONTACT

086 15040367023; xueqiong.wu@huaota.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: May 31, 2025
• Study Start: June 3, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)