Clinical trial NCT06158737: A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Migraine
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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 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 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 Criteria:

* 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: up to 168 days post-dose
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 168 days post-dose
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: up to 168 days post-dose
measure: Terminal Elimination Half-Life (t1/2)
timeFrame: up to 168 days post-dose
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: up to 168 days post-dose
measure: Cutaneous blood flow
timeFrame: up to 168 days post-dose
measure: Anti-drug antibodies (ADA)
timeFrame: up to 168 days post-dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Haiyan Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: