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

NCT06158737 | Unknown Phase 1

• 1 other identifier: JS010-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Incidence and severity of adverse events (AE) and serious adverse events (SAE) , as well as abnormalities in vital signs, electrocardiogram and laboratory tests.

  up to 168 days post-dose

Secondary Outcomes (6)

• Peak Plasma Concentration (Cmax)

  up to 168 days post-dose

• Time to Maximum Plasma Concentration (Tmax)

  up to 168 days post-dose

• Terminal Elimination Half-Life (t1/2)

  up to 168 days post-dose

• Area Under the Plasma Concentration Versus Time Curve (AUC)

  up to 168 days post-dose

• Cutaneous blood flow

  up to 168 days post-dose

Study Arms (2)

Experimental: JS010 injection

EXPERIMENTAL

Drug: JS010 injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JS010 injection DRUG

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 were enrolled in the experiment, 8 in each group.They were 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.

Experimental: JS010 injection

Placebo DRUG

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 were enrolled in the experiment, 8 in each group.They were 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Haiyan Li, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyan Li, PhD

CONTACT

+86 10-68966677; haiyanli1027@hotmail.com

Fangfang Wang, PhD

CONTACT

+86 10-68966677; doctorfancy@126.com

Study Design

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

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: December 6, 2023
• Study Start: May 9, 2023
• Primary Completion: June 29, 2024
• Study Completion: September 21, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)