Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05757596
Other study ID # VSA001-1001
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Visirna Therapeutics HK Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy adult volunteers. Eligible enrolled participants will initially receive VSA001 injection at the assigned dose level.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date December 31, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. The subjects voluntarily participate in this study who are able to read, understand, and sign the ICF before participation; and have a full understanding of the content, process and possible adverse reactions of the study and are able to complete the study in accordance with the requirements of the protocol. 2. Healthy male and female subjects aged between 18 and 55 years (both inclusive) at the time of informed consent. 3. Body mass index (BMI) = weight (kg)/height (m)2, within the range of 19.0-30.0 kg/m2 (both inclusive), and body weight no less than 50 kg. 4. In good general health and without clinically significant abnormalities as judged by the investigator, based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory results. 5. Negative serum pregnancy test within 72 h prior to initiation of study treatment in all premenopausal females and females who have been amenorrheic for less than 12 months. (Serum pregnancy test is not required for females who have undergone surgical sterilization, such as hysterectomy and/or bilateral oophorectomy, or those who have not experienced menses for 12 consecutive months and are judged to be postmenopausal based on factors such as age and castration therapy). 6. Subjects and their partners must agree to use adequate contraceptive methods prior to initiation of study treatment, during the study, and for at least 3 months after discontinuation of study treatment. 7. Fasting serum TGs >80 mg/dL (>0.903 mmol/L) at screening. Exclusion Criteria: 1. History or presence of significant or clinically significant diseases/abnormality, including but not limited to cardiac/cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, gallbladder, dermatological, hematological, immunological, neurologic, or psychiatric diseases/abnormality, or the disease that, in the judgement of the investigator, present a safety concern or affects the pharmacokinetic evaluation. 2. A family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death. 3. Subjects who are with acute exacerbation of any significant acute or chronic disease as judged by the investigator. 4. AST and ALT >2×upper limit of normal (ULN) , or total bilirubin >ULN at screening. 5. Serum creatinine estimated eGFR < 60 ml/min/1.73 m2 per MDRD formula. 6. Cardiac troponin (troponin I) above ULN at Screening. 7. Fasting serum TGs >300 mg/dL (>3.38 mmol/L) at screening. 8. Presence of other conditions or treatments that may affect the study results and interfere with the subject's participation in the study as assessed by the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VSA001 injection
The active drug is VSA001 injection. The active pharmaceutical ingredient (API) contained in VSA001 is a synthetic, double-stranded, hepatocyte targeted NAG-conjugated RNAi.
Placebo
0.9% Saline, volume matched

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Visirna Therapeutics HK Limited Arrowhead Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability Incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), and the relationship with VSA-01001.
Clinically significant abnormalities in laboratory tests, vital signs, physical examination, 12-lead electrocardiograms (ECG).
85 days
Secondary Pharmacokinetics parameter: Cmax Maximum plasma concentration (Cmax) 48 hours
Secondary Pharmacokinetics parameter: Tmax Time to maximum plasma concentration (Tmax) 48 hours
Secondary Pharmacokinetics parameter: AUC0-t Area under the plasma concentration-time curve from the time 0 to the last quantifiable time point (AUC0-t). 48 hours
Secondary Pharmacokinetics parameter: t1/2 Half-life (t1/2). 48 hours
Secondary Pharmacokinetics parameter: CL/F Apparent clearance (CL/F). 48 hours
Secondary Pharmacokinetics parameter: Vz/F Apparent volume of distribution (Vz/F). 48 hours
Secondary Pharmacodynamic (PD) parameters Change from baseline over time in fasting serum APOC3 and triglycerides (TGs). 85 days
See also
  Status Clinical Trial Phase
Withdrawn NCT06034899 - A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants Phase 1
Completed NCT05162274 - Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers. Phase 1
Completed NCT03748758 - Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers Phase 1
Recruiting NCT06008652 - A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers Phase 1
Terminated NCT02079480 - Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects Phase 1
Completed NCT01651325 - Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects Phase 1
Completed NCT01657838 - Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects Phase 1
Completed NCT01354379 - Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Administered by Sprayer Phase 1
Completed NCT01129466 - Effects of 2 Different Broccoli Sprout Containing Supplements on Nasal Cells in Healthy Volunteers N/A
Completed NCT04856969 - Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers Phase 1
Completed NCT01333462 - Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Phase 1
Completed NCT02942771 - A MAD Study of TT301/MW189 in Healthy Volunteers Phase 1
Completed NCT02822898 - Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults Phase 4
Completed NCT05017987 - Clinical Trial to Compare Pharmacokinetics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012 Phase 1
Completed NCT05074368 - Efficacy and Safety of Heterologous and Homologous COVID-19 Vaccination N/A
Completed NCT01672242 - Assessment of End Expiratory Lung Volumes in Healthy Subjects Using High Flow Oxygen (Vapotherm®) N/A
Completed NCT03878693 - 4-methylpyrazole and Acetaminophen Metabolism Early Phase 1
Completed NCT04204772 - A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers Early Phase 1
Completed NCT05154461 - Intestinal Ketone Bodies Interfere With the Glycemic Control N/A
Active, not recruiting NCT02058472 - Pharmacokinetic/Pharmacodynamic & Safety Study of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers Phase 1