Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infections

Keywords

HIV InfectionsIbImmunological 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

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
+27 more secondary outcomes

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.

Interventions

JL18008 20 μg/kgDrug

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 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).

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Jecho Biopharmaceuticals Co., Ltd.
Industrylead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

WW Domain-Containing OxidoreductasePopulation Groups

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital Diseases

Central Study Contacts

Prof. Taisheng Li

CONTACT

+86-10-69156114 litsh@263.net

Study Design

Study Type: interventional
Phase: phase 1 2
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

May 26, 2026

Actual (reported)

Primary Completion

February 12, 2027

Estimated

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.
+4 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (32)

Study Arms (6)

JL18008 20 μg/kg

Placebo (for 20 μg/kg Group)

JL18008 40 μg/kg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Placebo (for 40 μg/kg Group)

JL18008 70 μg/kg

Placebo (for 70 μg/kg Group)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (32)

Study Arms (6)

JL18008 20 μg/kg

Placebo (for 20 μg/kg Group)

JL18008 40 μg/kg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Placebo (for 40 μg/kg Group)

JL18008 70 μg/kg

Placebo (for 70 μg/kg Group)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations