MedDataX Logo

A Study to Evaluate HB0034 in Healthy Adult Participants

NCT ID: NCT05064345

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-03

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06999083

Healthy
RECRUITING PHASE1

A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants

NCT05460455

Healthy
COMPLETED PHASE1

A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

NCT06716151

Healthy
RECRUITING PHASE1

A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants

NCT06612970

Healthy
RECRUITING PHASE1

A Study of Injection HB0017 in Adult Healthy Volunteers

NCT04505033

Healthy Subjects
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HB0034 dose group 1

HB0034 single dose

Group Type ACTIVE_COMPARATOR

HB0034

Intervention Type DRUG

Recombinant Humanized Anti-IL-36R Monoclonal antibody

HB0034 dose group 2

HB0034 single dose

Group Type ACTIVE_COMPARATOR

HB0034

Intervention Type DRUG

Recombinant Humanized Anti-IL-36R Monoclonal antibody

HB0034 dose group 3

HB0034 single dose

Group Type ACTIVE_COMPARATOR

HB0034

Intervention Type DRUG

Recombinant Humanized Anti-IL-36R Monoclonal antibody

HB0034 dose group 4

HB0034 single dose

Group Type ACTIVE_COMPARATOR

HB0034

Intervention Type DRUG

Recombinant Humanized Anti-IL-36R Monoclonal antibody

HB0034 dose group 5

HB0034 single dose

Group Type ACTIVE_COMPARATOR

HB0034

Intervention Type DRUG

Recombinant Humanized Anti-IL-36R Monoclonal antibody

HB0034 dose group 6

HB0034 single dose

Group Type ACTIVE_COMPARATOR

HB0034

Intervention Type DRUG

Recombinant Humanized Anti-IL-36R Monoclonal antibody

HB0034 dose group 7

HB0034 single dose

Group Type ACTIVE_COMPARATOR

HB0034

Intervention Type DRUG

Recombinant Humanized Anti-IL-36R Monoclonal antibody

Matching placebo for each dose group

placebo, single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Palcebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HB0034

Recombinant Humanized Anti-IL-36R Monoclonal antibody

Intervention Type DRUG

Placebo

Palcebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

no other invention names no other invention names

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

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 (HCG).
* Further exclusions criteria apply.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Huaota Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian Schwabe

Role: PRINCIPAL_INVESTIGATOR

NZCR OpCo limited AKL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New zealand Clinical Research

Auckland, , New Zealand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

New Zealand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HB0034-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study to Evaluate Safety and PK of NTM-1634 vs Placebo Administered Intravenously in Healthy Adults
NCT03046550 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers
NCT04238364 COMPLETED PHASE1
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SIM0811 Injection in Healthy Chinese Adult Subjects
NCT07345364 NOT_YET_RECRUITING PHASE1
Study to Evaluate HT-4253 in Healthy Subjects
NCT06537817 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INCB054707
NCT05068466 COMPLETED PHASE1
Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, & Food Effect of Oral INCB000631 to Healthy Adult Participants
NCT06775327 COMPLETED PHASE1
A Phase I Study of XH-S004 in Healthy Volunteers
NCT06236841 NOT_YET_RECRUITING PHASE1
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
NCT03285620 COMPLETED PHASE1
A Phase 1, Randomized, Placebo-controlled, Single & Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Healthy Chinese Volunteers
NCT02750553 COMPLETED PHASE1
A Placebo-controlled Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
NCT04608513 COMPLETED PHASE1
Phase 1 Single Dose Escalation Study of CTB-001
NCT01647893 UNKNOWN PHASE1
A Study of Safety, Tolerability, and Pharmacokinetics of Single Doses of PHP-303 in Healthy Subjects
NCT03627845 COMPLETED PHASE1
Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB000631 When Administered Orally to Healthy Adult Participants
NCT07039929 TERMINATED PHASE1
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BT-114143 Injection in Healthy Subjects
NCT07169240 COMPLETED PHASE1
Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects
NCT06063291 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple s.c Doses HS-20004 in Healthy Chinese Volunteers
NCT02746315 COMPLETED PHASE1
Phase I Study to Evaluate Safety, Tolerability, and Pharmacokinetics of HS-10360 in Healthy Subjects.
NCT04986436 UNKNOWN PHASE1
Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
NCT02145234 COMPLETED PHASE1
A Trial of CRB4101 in Healthy Subjects
NCT05641181 UNKNOWN PHASE1
A Phase I Study of AG-348 in Healthy Volunteers
NCT02149966 COMPLETED PHASE1
Study to Evaluate HZN-457 in Healthy Volunteers
NCT05565768 COMPLETED PHASE1
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Administration of HS-10356 in Healthy Volunteers
NCT04652297 UNKNOWN PHASE1
Study of JMKX003142 Injection in Chinese Healthy Subjects
NCT06344533 NOT_YET_RECRUITING PHASE1
A Study of ALPN-303 in Adult Healthy Volunteers
NCT05034484 COMPLETED PHASE1
A Phase I Study of AG-348 in Healthy Volunteers
NCT02108106 COMPLETED PHASE1