Study of the Safety, Tolerability, and Pharmacokinetics of LV232 Capsules in Chinese Healthy Volunteers

Healthy Subjects Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-Controlled, Single-Centre,Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LV232 Capsules in Chinese Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06070857
• Other study ID #: LV232-01
• Status: Recruiting
• Phase: Phase 1
• Start date: October 5, 2023
• Est. completion date: July 2024

Study information

• Verified date: September 2023
• Source: Vigonvita Life Sciences
• Contact: Huaqing Duan
• Phone: +86-18061926005
• Email: huaqing.duan[@]vigonvita.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study consists of 10 dose groups, 8 subjects in each group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and pharmacokinetics characteristics.

Description:

The dose levels are planned at 1 mg, 2 mg, 4 mg, 8 mg, 15 mg, 25 mg,40 mg, 60 mg ,90 mg and 120mg. 6 subjects in each group will receive LV232 tablets and 2 subjects will receive placebo. The subject number of single dose group may increase or decrease depending on the safety and PK data obtained.1 mg dose group will be given by sentinel administration (i.e. 1 study drug, 1 placebo). Subjects who receive sentinel administration will be observed for 48 hours and investigator will evaluate the safety parameters (including symptoms, vital signs, physical examination, etc.).Based on observed tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels in the clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Aged 18 to 45 years old, males or females;

2. Body weight no less than 50.0 kg for male, no less than 45.0 kg for female,Body Mass Index of 19.0 to 26.0kg/m2;

3. Physical examination, vital signs examination, laboratory examination, electrocardiogram examination and B-ultrasound examination results were normal or abnormal without clinical significant;

4. Subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed;

5. Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.

Exclusion Criteria:

1. Subjects with hypersensitivity to LV232 or any of the excipients;

2. Subjects with allergic diseases or allergic constitution;

3. Subjects with skin diseases or a history of skin allergies;

4. Subjects with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, Hematologic System, metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;

5. Blood donation or blood loss = 400 mL within 3 months , or have a history of blood product use history

6. Subjects who have participated in clinical trials of other drugs within 3 months before screening;

7. Subjects who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products orally within 2 weeks before screening;

8. Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit ˜200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content);

9. Subjects who smoked more than 10 cigarettes or equivalent amounts of tobacco a day within one year before screening;

10. Subjects who can't quit smoking and drinking during the experiment;

11. Subjects who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody (TPPA) or human immunodeficiency virus antibody (Anti-HIV);

12. Abnormal and clinically significant chest radiographs (anteroposterior);

13. B ultrasound examination showed moderate to severe fatty liver;

14. Pregnant or lactating woman or male subjects whose spouse has a child care plan within 3 months;

15. The investigator believes that there are other factors that are not suitable for participating in this trial.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• LV232
Drug: LV232 1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg
• Placebo
Placebo:1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Vigonvita Life Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Adverse Events	7 days after treatment
Primary	Cmax	maximum observed plasma concentration	48 hours after administration
Primary	AUC0-t	area under the plasma concentration time curve from time zero to the last	48 hours after administration
Primary	AUC0-8	area under the plasma concentration time curve from time zero to infinity	48 hours after administration
Primary	AUC0-24h	area under the plasma concentration time curve from time zero to 24 hours	48 hours after administration
Primary	Tmax	time at which Cmax occurs	48 hours after administration
Primary	t1/2	half life of elimination	48 hours after administration
Primary	CL/F	apparent clearance	48 hours after administration
Primary	Vd/F	apparent volume of distribution during the terminal phase	48 hours after administration
Primary	Ke	elimination rate constant	48 hours after administration
Primary	MRT	mean Resident Time	48 hours after administration
Primary	BP	Blood Plasma Ratio	48 hours after administration
Primary	BRPP	binding rate of plasma protein	48 hours after administration
Secondary	structural of metabolites	Structure of main metabolites of LV232 in plasma, feces and urine	From time zero up to 96 hours post-dose following oral administration
Secondary	Ae	Cumulative excretion of LV232 and major metabolites in feces and urine	From time zero up to 96 hours post-dose following oral administration
Secondary	Fe%	Percentage of LV232 and major metabolites in feces and urine	From time zero up to 96 hours post-dose following oral administration
Secondary	CLr	renal clearance rate	From time zero up to 72 hours post-dose following oral administration
Secondary	Genetic polymorphisms in drug metabolism	Influence of genetic polymorphisms in drug metabolism enzymes on pharmacokinetics and safety	Before administration