A Phase I Study of XJ101 in Chinese Healthy Subjects

NCT06014736 | Unknown Phase 1

• 1 other identifier: XJ101-I
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.

Conditions

Staphylococcus Aureus Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

• Any adverse events that occurred among all subjects during the clinical trial, including clinical symptoms, vital signs or physical examination abnormalities, laboratory tests or 12-lead electrocardiogram abnormalities.

  From the time of informed consent through 92 days post dose.

Secondary Outcomes (10)

• Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity])

  From Day 1 through 92 days post dose.

• Area Under the Serum Concentration Time Curve from Time Zero to Last Measurable Concentration (AUC [0-Last])

  From Day 1 through 92 days post dose.

• Maximum Observed Serum Concentration (Cmax)

  From Day 1 through 92 days post dose.

• Terminal Phase Elimination Half-life (t1/2)

  From Day 1 through 92 days post dose.

• Elimination Rate Constant (Kel)

  From Day 1 through 92 days post dose.

Study Arms (2)

XJ101 for Injection

EXPERIMENTAL

XJ101 via intravenous(IV).

Drug: XJ101 for Injection

Placebo

PLACEBO COMPARATOR

Placebo via intravenous(IV).

Drug: Placebo

Interventions

XJ101 for Injection DRUG

XJ101 is a recombinant humanized single domain antibody-Fc (human immunoglobulin G1 type) fusion protein.

XJ101 for Injection

Placebo DRUG

Placebo contains only excipients.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 through 45 years at screening.
• Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (including critical values).
• The subjects have no pregnancy plan and voluntarily avoid pregnancy from signing the informed consent form until the end of the trail.
• Healthy on the basis of physical examination and medical and surgical history and twelve-lead electrocardiogram (ECG) without clinically relevant abnormalities.
• Written informed consent and any locally required authorization (eg, HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.

You may not qualify if:

• Subjects with any abnormalities of respiratory system, circulatory system, digestive system, nervous system, skeletal muscle system, blood and lymphatic system, immune system and endocrine system.
• History of allergy to drugs or biological products.
• Acute infection within 4 weeks prior to study entry.
• Suffer from diseases caused by Staphylococcus aureus within one year, such as bacteremia, sepsis and pyemia.
• Receipt of any standard vaccine within 4 weeks prior to investigational product dosing or plan to vaccinate during the study period.
• Receipt of any major surgery within 3 months prior to the start of the trial, or have not recovered from surgery, or plan to have a surgical during the trial.
• Those who cannot tolerate venipuncture, or have a history of injector and blood sickness, or are not suitable for venous blood collection.
• Subjects with a history of drug abuse or drug use, or those with positive urine drug screening.
• Blood donation or massive blood loss (\> 200 mL) within three months prior to screening or plan to donate blood, receive blood transfusions, or use blood products during the trial period or within 1 month after the end of the trial.
• Pregnant or lactating women.
• Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 14 days prior to screening.
• Smoke more than 5 cigarettes per day within three months prior to screening
• Frequent drinkers in the three months before screening, i.e. those who drink more than or equal to 14 units of alcohol per week on average (1 unit=17.7 ml ethanol, 1 unit=354 ml beer with 5% alcohol, 44.25 ml spirits with 40% alcohol, or 147.5 ml wine with 12% alcohol), or those who do not agree to ban alcohol during the study period.
• Evidence of infection with HBV, hepatitis C, HIV, or syphilis.
• Positive alcohol breath test.

Sponsors & Collaborators

• Starmab biologics（Shanghai）Co,.ltd: lead

Study Sites (1)

Shanghai General Hospita

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ding xueying

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 28, 2023
• Study Start: August 15, 2023
• Primary Completion: March 26, 2024
• Study Completion: September 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-01

Locations

CN (1)