To Evaluate the Safety of JL18008

NCT07629310 | Completed Phase 1

• 2 other identifiers: JL18008-HV/HIV INR-101（Ia）CTR20241578
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted in healthy adult volunteers to evaluate the safety and tolerability of a single injection of an investigational drug called JL18008. The study also examines how the body processes the drug and how it affects immune cells. Participants receive one intramuscular injection of either JL18008 at one of six dose levels (1, 5, 10, 20, 40, or 70 μg/kg) or a placebo (an inactive substance). The study is randomized, double-blind, and placebo-controlled, meaning participants and study staff do not know who receives the active drug or placebo. Blood samples are collected over 56 days to measure drug levels, immune cell counts (such as CD4⁺ T cells), and any antibodies that may form against the drug. The goal is to find a safe dose that can be tested in future studies of people with HIV who have low CD4⁺ T cells despite antiviral treatment.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0

  Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). AEs graded according to NCI CTCAE version 5.0. Assessed from Day 1 through Day 56.

  Up to 56 days

Secondary Outcomes (54)

• Change from Baseline in White Blood Cell Count (WBC)

  Up to 56 days

• Change from Baseline in Neutrophil Count (NEUT)

  Up to 56 days

• Change from Baseline in Eosinophil Count (EOS)

  Up to 56 days

• Change from Baseline in Basophil Count (BASO)

  Up to 56 days

• Change from Baseline in Lymphocyte Count (LYMPH)

  Up to 56 days

Study Arms (12)

Arm 1: JL18008 1 μg/kg

EXPERIMENTAL

Single intramuscular injection of JL18008 at 1 μg/kg.

Drug: JL18008 1 μg/kg

Arm 2: Placebo (for 1 μg/kg group)

PLACEBO COMPARATOR

Single intramuscular injection of placebo (JL18008 buffer).

Drug: Placebo (for 1 μg/kg Group)

Arm 3: JL18008 5 μg/kg

EXPERIMENTAL

Single intramuscular injection of JL18008 at 5 μg/kg.

Drug: JL18008 5 μg/kg

Arm 4: Placebo (for 5 μg/kg group)

PLACEBO COMPARATOR

Single intramuscular injection of placebo.

Drug: Placebo (for 5 μg/kg Group)

Arm 5: JL18008 10 μg/kg

EXPERIMENTAL

Single intramuscular injection of JL18008 at 10 μg/kg.

Drug: JL18008 10 μg/kg

Arm 6: Placebo (for 10 μg/kg group)

PLACEBO COMPARATOR

Single intramuscular injection of placebo.

Drug: Placebo (for 10 μg/kg Group)

Arm 7: JL18008 20 μg/kg

EXPERIMENTAL

Single intramuscular injection of JL18008 at 20 μg/kg.

Drug: JL18008 20 μg/kg

Arm 8: Placebo (for 20 μg/kg group)

PLACEBO COMPARATOR

Single intramuscular injection of placebo.

Drug: Placebo (for 20 μg/kg Group)

Arm 9: JL18008 40 μg/kg

EXPERIMENTAL

Single intramuscular injection of JL18008 at 40 μg/kg.

Drug: JL18008 40 μg/kg

Arm 10: Placebo (for 40 μg/kg group)

PLACEBO COMPARATOR

Single intramuscular injection of placebo.

Drug: Placebo (for 40 μg/kg Group)

Arm 11: JL18008 70 μg/kg

EXPERIMENTAL

Single intramuscular injection of JL18008 at 70 μg/kg.

Drug: JL18008 70 μg/kg

Arm 12: Placebo (for 70 μg/kg group)

PLACEBO COMPARATOR

Single intramuscular injection of placebo.

Drug: Placebo (for 70 μg/kg Group)

Interventions

JL18008 1 μg/kg DRUG

Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 1 μg/kg.

Arm 1: JL18008 1 μg/kg

JL18008 5 μg/kg DRUG

Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 5 μg/kg.

Arm 3: JL18008 5 μg/kg

JL18008 10 μg/kg DRUG

Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 10 μg/kg.

Arm 5: JL18008 10 μg/kg

JL18008 20 μg/kg DRUG

Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 20 μg/kg.

Arm 7: JL18008 20 μg/kg

JL18008 40 μg/kg DRUG

Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 40 μg/kg.

Arm 9: JL18008 40 μg/kg

JL18008 70 μg/kg DRUG

Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 70 μg/kg.

Arm 11: JL18008 70 μg/kg

Placebo (for 1 μg/kg Group) DRUG

JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 1 μg/kg.

Arm 2: Placebo (for 1 μg/kg group)

Placebo (for 5 μg/kg Group) DRUG

JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 5 μg/kg.

Arm 4: Placebo (for 5 μg/kg group)

Placebo (for 10 μg/kg Group) DRUG

JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 10 μg/kg.

Arm 6: Placebo (for 10 μg/kg group)

Placebo (for 20 μg/kg Group) DRUG

JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 20 μg/kg.

Arm 8: Placebo (for 20 μg/kg group)

Placebo (for 40 μg/kg Group) DRUG

JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 40 μg/kg.

Arm 10: Placebo (for 40 μg/kg group)

Placebo (for 70 μg/kg Group) DRUG

JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 70 μg/kg.

Arm 12: Placebo (for 70 μg/kg group)

Eligibility Criteria

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

You may qualify if:

• Voluntary participation in the study, ability to understand and comply with the protocol requirements, and provision of written informed consent.
• Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests (hematology, urinalysis, serum chemistry, infectious disease screening, coagulation) are normal or have no clinically significant abnormality.
• Male or female, age 18 to 55 years inclusive.
• Body weight: male ≥50.0 kg, female ≥45.0 kg. Body mass index (BMI) between 18.0 and 26.0 kg/m² inclusive. BMI = weight (kg) / height (m)².
• No clinically significant history of cardiovascular, hepatic, renal, gastrointestinal, neurological, or hematological disease.
• No plans for pregnancy within 6 months, and agreement to use effective contraception with their partner from screening until 3 months after the study completion. No donation of sperm or eggs during this period.

You may not qualify if:

• Lactating women; women of childbearing potential with menstrual disorders within 90 days before dosing; women of childbearing potential who had unprotected intercourse with a male partner within 28 days before dosing.
• Participation in any clinical trial of an investigational drug within 90 days before dosing, or still within the safety washout period of a previous trial on the day of dosing.
• Non-physiological blood loss of ≥200 mL (including trauma, blood draw, blood donation) within 60 days before dosing, or plan to donate blood during the study or within 30 days after dosing.
• Any major illness considered clinically significant by the investigator within 90 days before dosing.
• Major surgery within 60 days before dosing, or any surgery within 28 days before dosing.
• Fever or infectious illness within 28 days before dosing.
• Use of any medication (including prescription, non-prescription, herbal, or dietary supplements) within 14 days before dosing.
• Vaccination within 1 month before dosing, or plan to receive vaccination during the study period.
• History or dependence of alcohol or drug abuse, or drug use, or a positive urine drug screen at screening. Alcohol abuse defined as average weekly intake \>21 standard alcohol units. One standard unit contains 14 g of alcohol (e.g., 360 mL of 5% beer, 45 mL of 40% spirits, or 120 mL of 12% wine).
• Daily smoking of more than 5 cigarettes within 3 months before screening, or unable to refrain from smoking during the study.
• Vital signs at screening meeting any of the following: systolic blood pressure \<90 mmHg or \>140 mmHg; diastolic blood pressure \<50 mmHg or \>90 mmHg; pulse rate \<50 beats/min or \>100 beats/min.
• Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis antibody.
• Clinically evident gastrointestinal, hepatic, or renal abnormality that, in the investigator's opinion, may affect drug transport, absorption, distribution, metabolism, or excretion.
• Any other condition that, in the investigator's judgment, might affect the study results or interfere with the subject's participation throughout the study, including but not limited to other medical history (e.g., psychiatric disorder), abnormalities in vital signs, physical examination, electrocardiogram, or clinical laboratory tests.

Sponsors & Collaborators

• Jecho Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 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

Study Design

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

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 5, 2026
• Study Start: June 13, 2024
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)