Status:
UNKNOWN
A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Migraine
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study adopts a dose escalation design with six preset dose levels, namely 3mg, 30mg, 150mg, 300mg,600mg, 900mg, single subcutaneous injection. A total of 48 healthy subjects will be enrolled in t...
Eligibility Criteria
Inclusion
- Subject understands and voluntarily signs a written informed consent form (ICF).
- Healthy male or female subjects aged 18-45 years (inclusive) at the time of signing informed consent.
- The body mass index (BMI) at screening was in the range of 18.5\~28.0kg/m2 (inclusive).
- Female subjects must meet the following conditions: no fertility (e.g. documented hysterectomy, bilateral transfusion;
- Blood pregnancy detection knot during ovular tubule resection or ligation, or menopause for more than 1 year), or screening of fertile persons' results were negative, and they were willing to use strict and effective contraceptive methods (such as medication or barrier methods) during the study period.
- Male subjects were required to consent to a strict and effective form of contraception.
- · Subjects are willing and able to complete the procedures and examinations associated with the trial, and can maintain a stable diet, exercise and ohter lifestyle habits during the trial.
Exclusion
- Subjects' forearm skin could not be stimulated by capsaicin, or was unresponsive or abnormally responsive to capsaicin stimulation.
- There is medical history or clinical evidence that the subject has a serious acute or chronic illness (including, but not limited to:
- Heart, kidney, nerve, endocrine, blood, immune, infection, metabolic dysfunction, etc.), by investigator judged that participating in the study could confound the results or put the subjects at risk.
- There is obvious concomitant disease, or physical examination, laboratory examination, chest X-ray, abdominal B-ultrasound, and electrocardiogram which reveals any clinically significant abnormalities, discomfort or disease. According to the researchers, it is not in line with clinical practice.
- There is a history of malignancy, except for carcinoma in situ that has been completely resected surgically.
- Drug abuse or alcohol dependence within the last 1 year.
- A known history of HIV and/or syphilis infection, or a positive test for HIV and/or syphilis antibodies at screening;
- Known history of hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection, or hepatitis B surface at the time of screening
- Antigen (HBsAg) and/or hepatitis C antibody positive.
- Had undergone abdominal surgery or endoscopic intestinal surgery within 6 months prior to randomization.
- Had undergone major surgical treatment within 6 months prior to randomization.
- Had received hospitalization within 3 months prior to randomization.
- Blood donation or blood loss ≥300ml in the 3 months prior to randomization.\[17\] Previously received drugs that target CGRP or CGRP receptors.
- Use of any therapeutic or investigational biologics in the 6 months prior to randomization.
- Participated in any of the trial drug interventions within 3 months or 5 half-lives (whichever is older) prior to randomization
- The clinical study.
- · Had used any prescription drugs or drugs within 30 days prior to randomization or 5 half-lives, whichever is older
- Remedies, including Chinese herbs, vitamins and dietary supplements (hormones used in contraception for women of childbearing age)
- Except for birth control pills).
- Received live vaccine within 30 days prior to randomization.
- A history of allergy to biological agents, including monoclonal antibodies.
- A history of severe allergies to food, drugs, insect bites, etc.
- Pregnant and lactating women.
- Any other situation in which the investigator deems it inappropriate to participate in the study, such as the subject having potential compliance problems; Unable to complete all inspections and evaluations as required by the programme
Key Trial Info
Start Date :
May 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 21 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06158737
Start Date
May 9 2023
End Date
September 21 2024
Last Update
December 6 2023
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191