Actively Recruiting
A Phase I Study of LX22001 for Injection in Healthy Subjects
Led by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. · Updated on 2024-08-20
70
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of LX22001 for injection in healthy subjects.
CONDITIONS
Official Title
A Phase I Study of LX22001 for Injection in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who understand the study and voluntarily sign informed consent
- Healthy Chinese males and females aged 18 to 45 years
- Body mass index between 19.0 and 26.0 kg/m2
- Weight of at least 50 kg for males and 45 kg for females
- Willing to use effective contraception and no plans for sperm or egg donation until 3 months after last dose
- Able to communicate well and comply with study requirements
You will not qualify if you...
- Allergy to multiple drugs, foods, pollen, or components of study drugs
- History of atopic allergic diseases like asthma or dermatitis
- Diseases affecting drug absorption or significant gastrointestinal conditions
- Major gastrointestinal surgery except appendicitis or prolapse surgery
- Chronic or serious illness within the last year affecting major body systems
- Clinically significant abnormalities in physical exams or lab tests
- Positive tests for HIV, hepatitis B or C, or syphilis
- Women not using effective contraception, pregnant, or breastfeeding
- History of drug abuse within 5 years or drug use within 3 months
- Smoking more than 5 cigarettes daily or nicotine use within 3 months
- Drinking more than 14 alcohol units weekly or alcohol use within 48 hours
- Medication use within 1 month before screening
- Participation in other clinical trials with investigational drugs within 3 months
- Blood donation or transfusion of more than 200 mL within 3 months
- Consumption of caffeine-containing products within 48 hours before dosing
- Consumption of grapefruit, limes, or certain fruits within 7 days before screening
- Unable to tolerate intravenous administration
- Involvement in planning or conducting this study
- Any condition that may interfere with consent, protocol adherence, safety, or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
L
Li Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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