Study of JMKX003142 Injection in Chinese Healthy Subjects

NCT06344533 | Not Yet Recruiting Phase 1

• 1 other identifier: JMKX003142iv-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (2)

• Number of the Adverse Events that are related to the single dose treatment

  single dose safety single dose safety

  From Baseline to Day7

• Number of the Adverse Events that are related to the multiple dose treatment

  multiple dose safety multiple dose safety

  From Baseline to Day12

Study Arms (2)

JMKX003142 Injection

EXPERIMENTAL

Single and multiple doses of JMKX003142 Injection administered intravenously.

Drug: JMKX003142 Injection

Placebo

PLACEBO COMPARATOR

Placebo administered intravenously.

Drug: Placebo

Interventions

JMKX003142 Injection DRUG

JMKX003142 Injection will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.

JMKX003142 Injection

Placebo DRUG

Matching placebo will be administered intravenously once in SAD cohorts and once daily in MAD cohorts for 5 consecutive days.

Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female subjects aged 18-45 years (including boundary values).
• Able to sign a written informed consent form.
• Physical examination, clinical laboratory examination value, Virology examination, vital signs and ECG examination are confirmed by the researcher to be normal or abnormal without clinical significance
• The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol

You may not qualify if:

• Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, as well as habitual constipation, gastrointestinal bleeding history, which is judged to be inappropriate for the study by the investigators
• Participants in any other clinical study within 3 months prior to the first administration of this study
• The investigators believe that the subject has other factors that are not suitable for participating in this experiment
• Pregnant or lactating women

Sponsors & Collaborators

• Jemincare: lead
• Zhejiang Hangyu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Central Study Contacts

Yiming Dong, MD

CONTACT

021-58306003; dongyiming@jemincare.com

Haiyan Li, MD

CONTACT

010-82266226; haiyanli1027@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 3, 2024
• Study Start: April 10, 2024
• Primary Completion: January 31, 2025
• Study Completion: May 30, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)