A Phase I Clinical Trial of JH013 Injection

NCT06633055 | Not Yet Recruiting Phase 1

• 1 other identifier: BPL-JH013-HV-1001
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase I clinical trial with a single dose escalation to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JH013 injection in healthy subjects

Conditions

Healthy Subjects (HS)

Keywords

Dose escaltion

Outcome Measures

Primary Outcomes (1)

• Safety metrics

  Including Adverse events defined by CTCAE 5.0（Common Terminology Criteria for Adverse Events Version 5.0) Version 5.0）

  from Administration to Day57.

Secondary Outcomes (7)

• t1/2

  from Administration to Day57.

• Cmax

  from Administration to Day57.

• CD45+CD19+ B cell

  from Administration to Day57.

• B cell activation factor (BAFF)

  from Administration to Day57.

• JH013 antibody

  from Administration to Day57.

Study Arms (4)

JH013 injections 75mg

EXPERIMENTAL

6 subjects receive JH013 at a dose of 75 mg and 2 subjects receive the same volume placebo

Drug: JH013 injection; Drug: Placebo

JH013 injections 150mg

EXPERIMENTAL

6 subjects will receive JH013 injections 150mg，2 subjects receive the same volume placebo

Drug: JH013 injection; Drug: Placebo

JH013 injections 300mg

EXPERIMENTAL

6 subjects receive JH013 at a dose of 300 mg and 2 subjects receive the same volume placebo

Drug: JH013 injection; Drug: Placebo

JH013 injections 500mg

EXPERIMENTAL

6 subjects receive JH013 at a dose of 500 mg and 2 subjects receive the same volume placebo

Drug: JH013 injection; Drug: Placebo

Interventions

JH013 injection DRUG

JH013 injection is a BAFF-R inhibitor monoclonal antibody

Also known as: JH013

JH013 injections 150mg; JH013 injections 300mg; JH013 injections 500mg; JH013 injections 75mg

Placebo DRUG

JH013 injections placebo

Also known as: JH013 Placebo

JH013 injections 150mg; JH013 injections 300mg; JH013 injections 500mg; JH013 injections 75mg

Eligibility Criteria

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

You may qualify if:

• Healthy adult male or female aged 18-55 years (age including cut-off values);
• There were no abnormalities in clinically significant vital signs, physical examination, laboratory tests, and 12-lead ECG;
• Weight ≥ 50 kg for males and ≥45 kg for females; Body mass index (BMI) between 18.0 and 26 kg/m2 (including cut-off values, body mass index = weight/height2);
• Females of potential childbearing potential with a negative blood β-HCG test within 72 hours prior to dosing (postmenopausal women who have amenorrhea for at least 12 months are considered non-childbearing and women who are known to have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or ligation, and a pregnancy test is not required);
• Subjects understand and comply with the study process, participate voluntarily, and sign the informed consent form

You may not qualify if:

• Subject has a history of malignancy prior to screening, or has been screened for malignancy, and the possibility of malignancy cannot be reasonably ruled out
• Subject has a history of autoimmune disease prior to screening
• γ interferon release assay results ≥ 2 times the upper limit of normal
• Any history of infection requiring hospitalization or receiving antivirals, antibiotics, antifungals, antiparasitic drugs, or vaccinations within 4 weeks prior to the application of the study drug
• Those who have positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody or syphilis antibody
• Patients with a history of previous and/or current heart disease (including New York Heart Association Class III/IV heart failure), gastrointestinal, renal, endocrine, neurological, autoimmune, hematologic (including pancytopenia, aplastic anemia or anaemia, etc.), metabolic (including diabetes), severe lung disease and psychiatric illness
• History of organ transplantation: such as heart, lung, kidney, liver, or hematopoietic stem cell transplantation

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Officials

• chen Rui, Dr

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Yucheng, Master

CONTACT

010-51571020; wangyucheng@biotechplc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 9, 2024
• Study Start: October 31, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share