A Study to Evaluate JL18008 in Subject With HIV Immunological Non-Responders

NCT07579741 | Not Yet Recruiting Phase 1

• 1 other identifier: JL18008-HV/HIV INR-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The Phase Ib clinical trial is an add-on study based on combination antiretroviral therapy (cART). It adopts a multicenter, randomized, double-blind, placebo-controlled, multiple-dose design to evaluate the safety and efficacy of multiple intramuscular injections of JL18008 added to cART in HIV immunological non-responders (INRs). Based on the Phase Ia clinical data, three dose groups are planned for the Phase Ib trial: 20, 40, and 70 μg/kg of JL18008. Each group is planned to enroll 10 subjects (8 receiving active drug and 2 receiving placebo). All subjects must maintain their original cART regimen unchanged. Subjects in the active treatment groups will receive JL18008 injection in addition to cART, while those in the control group will receive placebo (JL18008 injection buffer) in addition to cART. The dosing regimen is tentatively once weekly (QW) for 4 consecutive weeks, which constitutes one treatment cycle, followed by an observation/follow-up period. The study drug will be administered by intramuscular injection.

Conditions

HIV Infections

Keywords

HIV Infections; Ib; Immunological Non-Responders

Outcome Measures

Primary Outcomes (7)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by DAIDS v2.1

  The incidence and severity of adverse events (AEs) and serious adverse events (SAEs). Adverse events are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1. Assessed from first dose up to Week 24.

  Up to 24 weeks

• Change from Baseline in Vital Signs: Pulse Rate (bpm)

  Change from baseline in pulse rate. Measured in beats per minute (bpm). Assessed at baseline and Weeks 1, 4, 8, 12, 16, 20, and 24.

  Up to 24 weeks

• Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (mmHg)

  Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP). Both measured in millimeters of mercury (mmHg). Assessed at baseline and Weeks 1, 4, 8, 12, 16, 20, and 24.

  Up to 24 weeks

• Change from Baseline in Hematology Parameters

  Change from baseline in hematology parameters including white blood cell count (10\^9/L), hemoglobin (g/L), platelet count (10\^9/L), neutrophil count (10\^9/L), lymphocyte count (10\^9/L), and red blood cell count (10\^12/L). Assessed at baseline and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.

  Up to 24 weeks

• Change from Baseline in Serum Chemistry Parameters

  hange from baseline in serum chemistry parameters including alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L), creatinine (μmol/L), triglycerides (mmol/L), total cholesterol (mmol/L), glucose (mmol/L), and electrolytes (Na⁺, K⁺, Cl-, Ca²⁺, Mg²⁺, Pi). Assessed at baseline and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.

  Up to 24 weeks

• Change from Baseline in Coagulation Parameters

  Change from baseline in coagulation parameters including international normalized ratio (INR), activated partial thromboplastin time (APTT, seconds), prothrombin time (PT, seconds), and fibrinogen (g/L). Assessed at baseline and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.

  Up to 24 weeks

• Change from Baseline in ECG Parameter: QTcF Interval

  Change from baseline in the QT interval corrected for heart rate using Fridericia's formula (QTcF). Measured in milliseconds (ms). Assessed at baseline and Weeks 1, 4, 8, 12, 16, 20, and 24.

  Up to 24 weeks

Secondary Outcomes (32)

• Proportion of Participants with CD4⁺ T Cell Count Increase ≥100 cells/μL from Baseline

  Up to 24 weeks

• Proportion of Participants Achieving CD4⁺ T Cell Count ≥500 cells/μL

  Up to 24 weeks

• Proportion of Participants with Average CD4⁺ T Cell Count Increase ≥100 cells/μL over 12 Weeks

  Baseline through Week 12

• Proportion of Participants with Average CD4⁺ T Cell Count ≥500 cells/μL over 12 Weeks

  Baseline through Week 12

• Proportion of Participants with Average CD4⁺ T Cell Count Increase ≥100 cells/μL over 24 Weeks

  Baseline through Week 24

Study Arms (6)

JL18008 20 μg/kg

EXPERIMENTAL

Participants receive JL18008 20 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen.

Drug: JL18008 20 μg/kg

Placebo (for 20 μg/kg Group)

PLACEBO COMPARATOR

Participants receive placebo (JL18008 injection buffer) intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen.

Drug: Placebo (for 20 μg/kg Group)

JL18008 40 μg/kg

EXPERIMENTAL

Participants receive JL18008 40 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen.

Drug: JL18008 40 μg/kg

Placebo (for 40 μg/kg Group)

PLACEBO COMPARATOR

Participants receive placebo (JL18008 injection buffer) intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen.

Drug: Placebo (for 40 μg/kg Group)

JL18008 70 μg/kg

EXPERIMENTAL

Participants receive JL18008 70 μg/kg intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen.

Drug: JL18008 70 μg/kg

Placebo (for 70 μg/kg Group)

PLACEBO COMPARATOR

Participants receive placebo (JL18008 injection buffer) intramuscularly once weekly for 4 weeks, in addition to their stable cART regimen.

Drug: Placebo (for 70 μg/kg Group)

Interventions

JL18008 20 μg/kg DRUG

Participants receive JL18008 20 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

JL18008 20 μg/kg

Placebo (for 40 μg/kg Group) DRUG

Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

Placebo (for 40 μg/kg Group)

JL18008 70 μg/kg DRUG

Participants receive JL18008 70 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

JL18008 70 μg/kg

Placebo (for 70 μg/kg Group) DRUG

Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

Placebo (for 70 μg/kg Group)

Placebo (for 20 μg/kg Group) DRUG

Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

Placebo (for 20 μg/kg Group)

JL18008 40 μg/kg DRUG

Participants receive JL18008 40 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

JL18008 40 μg/kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years (inclusive), male or female.
• Body mass index (BMI) 18.0 to 32.0 kg/m² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females.
• Receiving combination antiretroviral therapy (cART) for at least 48 months, with a stable antiretroviral regimen for at least 3 months prior to enrollment.
• Maintained HIV-1 RNA below 50 copies/mL for at least 36 months (the earliest test date more than 36 months before enrollment), including transient viral blips (single HIV-1 RNA measurement between 50 and 200 copies/mL after excluding laboratory error). At least two HIV-1 RNA results \<50 copies/mL must be available (one may be from screening).
• Immunological non-responder criteria: CD4⁺ T cell count ≤350 cells/μL within 1 year before screening. At least three CD4⁺ T cell counts ≤350 cells/μL within 4 years before enrollment, with intervals of ≥3 months between tests (the third may be from screening).
• Willing to use effective non-pharmacological contraception with partner from screening until 3 months after study completion, and no plan for sperm/egg donation during this period.
• Able to understand and provide written informed consent, and willing to comply with all protocol-specified visits and procedures.

You may not qualify if:

• Known allergy to the study drug or any of its excipients.
• Receipt of immunosuppressants, immunomodulators, or systemic cytotoxic therapy within 3 months before screening.
• Receipt of hormone therapy within 1 month before screening, except for daily doses ≤10 mg prednisone or equivalent.
• History of severe autoimmune disease requiring systemic treatment or hospitalization, or any active autoimmune disease requiring treatment (including multiple sclerosis).
• History of systemic infection (viral, bacterial, parasitic, or fungal) requiring systemic treatment and/or hospitalization, or other opportunistic infection, within 30 days before screening.
• Active tuberculosis lesion within 30 days before screening.
• Blood disorders associated with hypersplenism (e.g., thalassemia, hereditary spherocytosis, Gaucher's disease, autoimmune hemolytic anemia) or history of splenectomy.
• Chronic diarrhea.
• Severe cardiovascular disease within 6 months before screening, including myocardial infarction, unstable angina, congestive heart failure (NYHA class ≥II), or arrhythmia requiring medication.
• Uncontrolled hypertension, defined as resting systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg on at least two repeated measurements on different days despite antihypertensive treatment.
• Positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCV-Ab) with detectable HCV-RNA, or active syphilis.
• Any of the following laboratory abnormalities at screening: hemoglobin \<90 g/L; neutrophil count \<1.5×10⁹/L; platelet count \<100×10⁹/L; serum creatinine \>1.5× upper limit of normal (ULN); alanine aminotransferase \>2.5×ULN; aspartate aminotransferase \>2.5×ULN; alkaline phosphatase \>2.5×ULN; total bilirubin \>1.5×ULN; international normalized ratio \>1.5; activated partial thromboplastin time \>1.5×ULN.
• Diagnosis of cancer within the screening period.
• Severe neurological or psychiatric disease, or history of seizures.
• History of drug abuse within 3 months before screening, or positive urine drug screen (including morphine, methamphetamine, ketamine, MDMA, THC, cocaine), or history of alcohol abuse.

Sponsors & Collaborators

• Jecho Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

HIV Infections

Interventions

WW Domain-Containing Oxidoreductase; Population Groups

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Demography; Population Characteristics

Central Study Contacts

Prof. Taisheng Li

CONTACT

+86-10-69156114; litsh@263.net

Study Design

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

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 12, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): July 21, 2027
• Study Completion (Estimated): September 28, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)