A Study of JS026 and JS026 Together With JS016 for Treatment of COVID-19

NCT05167279 | Completed Phase 1

• 1 other identifier: JS026-001-I
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single-center phase I clinical trial of JS026 and JS026 + JS016 Injection. The objective of the study is to evaluate the safety, tolerability, PK profile and immunogenicity of a single intravenous infusion of JS026 and JS026 + JS016 Injection in healthy subjects. In this study, the single ascending dose design will be adopted, JS026 will be administered sequentially from low dose group to high dose group, and each subject can only receive an intravenous infusion at one dose level. Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) will be set to receive an intravenous infusion of JS026, and two dose groups (300 mg JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set for JS026 + JS016. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1. Four subjects will be enrolled in each of JS026 30 mg and 100 mg groups, and 8 subjects will be enrolled in each of other dose groups, totally 48 subjects.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence and severity of any adverse events (AEs) occurring during the clinical trial per CTCAE V5.0

  Incidence and severity of any adverse events (AEs) occurring during the clinical trial, including serious adverse events (SAEs), and adverse events of special interest (AESIs), as well as abnormalities in clinical symptoms, vital signs, physical examination, laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs will be observed for all the subjects, the their clinical manifestations and features, severity, time to onset, end time, therapeutic measures and outcomes will be recorded, and the correlation of the adverse events with the investigational product will be judged.

  85 days

Secondary Outcomes (7)

• Pharmacokinetics: AUC

  Day 1 to D85

• Pharmacokinetics: Tmax

  Day 1 to D85

• Pharmacokinetics: Cmax

  Day 1 to D85

• Pharmacokinetics: Vd

  Day 1 to D85

• Pharmacokinetics: CLt

  Day 1 to D85

Study Arms (7)

JS026/placebo 30 mg

PLACEBO COMPARATOR

4 patients will be enrolled in this arm.

Biological: JS026/placebo; Biological: JS016/placebo

JS026/placebo 100 mg

PLACEBO COMPARATOR

4 patients will be enrolled in this arm.

Biological: JS026/placebo; Biological: JS016/placebo

JS026/placebo 300 mg

PLACEBO COMPARATOR

8 patients will be enrolled in this arm.

Biological: JS026/placebo; Biological: JS016/placebo

JS026/placebo 600 mg

PLACEBO COMPARATOR

8 patients will be enrolled in this arm.

Biological: JS026/placebo; Biological: JS016/placebo

JS026/placebo 1000 mg

PLACEBO COMPARATOR

8 patients will be enrolled in this arm.

Biological: JS026/placebo; Biological: JS016/placebo

JS026/placebo 300 mg + JS016/placebo1200 mg

PLACEBO COMPARATOR

8 patients will be enrolled in this arm.

Biological: JS026/placebo; Biological: JS016/placebo

JS026/placebo 600 mg + JS016/placebo 1200 mg

PLACEBO COMPARATOR

8 patients will be enrolled in this arm.

Biological: JS026/placebo; Biological: JS016/placebo

Interventions

JS026/placebo BIOLOGICAL

Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) will be set to receive an intravenous infusion of JS026/placebo on Day1, and two dose groups (300 mg JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set to receive an intravenous infusion of JS026/placebo + JS016/placebo on Day1. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1.

JS026/placebo 100 mg; JS026/placebo 1000 mg; JS026/placebo 30 mg; JS026/placebo 300 mg; JS026/placebo 300 mg + JS016/placebo1200 mg; JS026/placebo 600 mg; JS026/placebo 600 mg + JS016/placebo 1200 mg

JS016/placebo BIOLOGICAL

Two dose groups (300 mg + 1200 mg, and 600 mg + 1200 mg) will be set to receive an intravenous infusion of JS026/placebo + JS016/placebo on Day1. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1.

JS026/placebo 100 mg; JS026/placebo 1000 mg; JS026/placebo 30 mg; JS026/placebo 300 mg; JS026/placebo 300 mg + JS016/placebo1200 mg; JS026/placebo 600 mg; JS026/placebo 600 mg + JS016/placebo 1200 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female healthy subjects
• Body weight ≥ 50 kg for males and ≥ 45 kg for females
• Female subjects must meet the following criteria: not of childbearing potential (e.g., documented hysterectomy, bilateral salpingectomy or ligation, or more than 1 year of amenorrhea), or of childbearing potential with a negative blood pregnancy test at screening, and willing to take strict and effective contraceptive measures (e.g., abstinence, medication, or barrier method \[e.g., contraceptive sponge, vaginal cuff, vaginal diaphragm, cervical cap, etc.\]) for 6 months after dosing. Male subjects must agree to take strict and effective contraceptive measures (eg, abstinence, drug, or barrier method \[e.g., male condom\]) for 6 months after dosing.
• Results of medical evaluations, including physical examination, vital signs, laboratory tests, and other auxiliary examinations (chest imaging, abdominal B ultrasound, ECG, etc.) are normal or abnormal without clinical significance.
• Able to read and understand the contents of the trial, willing to participate in the trial and comply with the trial protocol and procedures, and having signed the written ICF.

You may not qualify if:

• Patients with past medical history or current clinically significant concomitant diseases;
• History of malignancies within 5 years.
• Receiving any prescription drugs or over-the-counter drugs, including herbal remedies, vitamins, and dietary supplements, within 14 days prior to screening.
• Participating in any clinical trial with drug intervention within 3 months prior to screening, or the drug is within the elimination phase (5 elimination half-lives), whichever is longer.
• Receiving any therapeutic or investigational biologic within 6 months prior to screening.
• With a history of drug abuse within 1 year, or a positive result at screening.
• Females who are pregnant or lactating.
• Any other condition that the investigator deems inappropriate to participate in the trial, such as subject's mental or legal incapacity, potential compliance problems, and failure to complete the study-related procedures according to the requirements of the protocol, as determined by the investigator.

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

JS026; etesevimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 22, 2021
• Study Start: December 16, 2021
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CN (1)