Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy Subjects

Safety and Tolerability Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003002 in Single and Multiple Ascending Dose Randomized，Doubled-blind Phase 1 Study in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907382
• Other study ID #: JY-JM3002-101
• Status: Recruiting
• Phase: Phase 1
• Start date: May 9, 2023
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: Jemincare
• Contact: Jing Xu
• Phone: 021-52887926
• Email: xujing2[@]jimincare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002 in single and multiple ascending dose randomized，doubled-blind phase 1 study in healthy subjects

Description:

Pharmacokinetic (PK) parameters, Pharmacodynamics

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects aged 18-45 years (inclusive);-

2. With normal or abnormal but clinically insignificant comprehensive physical examination (vital signs, physical examination), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function test) and, 12-lead ECG;

3. Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form.

Exclusion Criteria:

1. Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial

2. Subjects with history of or current malignancy;

3. Participant who the researchers believe that there are volunteers who are not suitable for

Related Conditions & MeSH terms

• Safety and Tolerability

Intervention

Drug:
• JMKX003002 will be administered orally
oral once
• JMKX003002 will be administered orally
oral once
• JMKX003002 will be administered orally
oral once
• Placebo in Cohorts 1 to 5
oral once
• Placebo in 2 Cohorts
oral once

Locations

Country	Name	City	State
China	Huashan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jemincare

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of the Adverse Events that are related to the single dose treatment	single dose safety	from baseline to Day 11
Primary	Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18	multiple dose safety	from baseline to Day 18