A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects

Last updated: November 28, 2023
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Pain (Pediatric)

Headaches

Chronic Pain

Treatment

Placebo

JS010 injection

Clinical Study ID

NCT06158737
JS010-001
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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 the experiment, 8 in each group.They will be randomly assigned to receive JS010 injection and matching placebo in a ratio of 3:1. In accordance with the dose-escalation principle,Starting from the lowest initial dose, increasing to the higher dose and proceeding in sequence. Each subject can receive only one dose Level of single subcutaneous administration.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 signinginformed 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. documentedhysterectomy, bilateral transfusion; Blood pregnancy detection knot during ovular tubule resection or ligation, or menopause formore than 1 year), or screening of fertile persons' results were negative, and they werewilling to use strict and effective contraceptive methods (such as medication or barriermethods) 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 withthe trial, and can maintain a stable diet, exercise and ohter lifestyle habits during thetrial.

Exclusion

Exclusion Criteria:

  • Subjects' forearm skin could not be stimulated by capsaicin, or was unresponsive orabnormally responsive to capsaicin stimulation.
  • There is medical history or clinical evidence that the subject has a serious acute orchronic illness (including, but not limited to: Heart, kidney, nerve, endocrine, blood, immune, infection, metabolic dysfunction, etc.), byinvestigator judged that participating in the study could confound the results or put thesubjects at risk.
  • There is obvious concomitant disease, or physical examination, laboratory examination,chest X-ray, abdominal B-ultrasound, and electrocardiogram which reveals anyclinically significant abnormalities, discomfort or disease. According to theresearchers, it is not in line with clinical practice.
  • There is a history of malignancy, except for carcinoma in situ that has beencompletely 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/orsyphilis antibodies at screening;
  • Known history of hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection, orhepatitis 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 priorto 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 torandomization.
  • 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 5half-lives, whichever is older Remedies, including Chinese herbs, vitamins and dietary supplements (hormones used incontraception 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 inthe study, such as the subject having potential compliance problems; Unable tocomplete all inspections and evaluations as required by the programme

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
May 09, 2023
Estimated Completion Date:
September 21, 2024

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

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