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| Column | Value |
|---|---|
| Trial registration number | NCT05167279 |
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Full text link
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
yajie_wang@junshipharma.com |
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Registration date
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
2021-12-22 |
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Recruitment status
Last imported at : Aug. 2, 2023, 8 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Sequential assignment |
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Masking
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: 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. |
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Exclusion criteria
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
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. |
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Number of arms
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
7 |
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Funding
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Shanghai Junshi Bioscience Co., Ltd. |
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Inclusion age min
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
60 |
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Countries
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
48 |
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primary outcome
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Safety: Incidence and severity of any adverse events (AEs) occurring during the clinical trial per CTCAE V5.0 |
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Notes
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Phase 1 |
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Arms
Last imported at : Dec. 30, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "30 mg", "treatment_id": 2091, "treatment_name": "Js026", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "100mg", "treatment_id": 2091, "treatment_name": "Js026", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "300mg", "treatment_id": 2091, "treatment_name": "Js026", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "600mg", "treatment_id": 2091, "treatment_name": "Js026", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1000mg", "treatment_id": 2091, "treatment_name": "Js026", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1200mg+300mg", "treatment_id": 2093, "treatment_name": "Js016+js026", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "1200mg+600mg", "treatment_id": 2093, "treatment_name": "Js016+js026", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}] |