A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension

NCT06328400 | Completed Phase 1

• 1 other identifier: VV116-RSV-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a multi dose, randomized, double-blind, placebo-controlled, single center Phase I clinical study. The purpose of this study is to evaluate the safety, tolerability, and PK characteristics of Deuteromide Hydrobromide for Suspension administered multiple times in healthy volunteers.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events

  From Day1 to Day10 after administration

Secondary Outcomes (5)

• Cmax

  168 hours after administration

• Tmax

  168 hours after administration

• AUC0- t

  168 hours after administration

• AUC0-∞

  168 hours after administration

• t1/2

  168 hours after administration

Study Arms (3)

Deuremidevir Hydrobromide for Suspension 900mg group, twice a day

EXPERIMENTAL

9 subjects will receive Deuremidevir Hydrobromide for Suspension 900mg, orally, Q12h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 900mg, orally, Q12h, 5.5 days.

Drug: Deuremidevir Hydrobromide for Suspension; Drug: Deuremidevir Hydrobromide for Suspension Placebo

Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day

EXPERIMENTAL

9 subjects will receive Deuremidevir Hydrobromide for Suspension 900mg, orally, Q8h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 900mg, orally, Q8h, 5.5 days.

Drug: Deuremidevir Hydrobromide for Suspension; Drug: Deuremidevir Hydrobromide for Suspension Placebo

Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day

EXPERIMENTAL

9 subjects will receive Deuremidevir Hydrobromide for Suspension 1200mg, orally, Q12h, 5.5 days; 3 subjects will receive Deuremidevir Hydrobromide for Suspension Placebo 1200mg, orally, Q12h, 5.5 days.

Drug: Deuremidevir Hydrobromide for Suspension; Drug: Deuremidevir Hydrobromide for Suspension Placebo

Interventions

Deuremidevir Hydrobromide for Suspension DRUG

Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, twice a day Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day Experimental: Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day

Also known as: VV116

Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day; Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day; Deuremidevir Hydrobromide for Suspension 900mg group, twice a day

Deuremidevir Hydrobromide for Suspension Placebo DRUG

Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, twice a day Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day Experimental: Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day

Also known as: VV116 Placebo

Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day; Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day; Deuremidevir Hydrobromide for Suspension 900mg group, twice a day

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 45 years old, males or females;
• Body weight no less than 45 kg, Body Mass Index of 18 to 25 kg/m2;
• Vital signs examination, physical examination, laboratory examination and electrocardiogram examination results were normal or abnormal without clinical significance;
• Subjects who are willing to take proper contraceptive during the study and within 3 months after the last administration;
• Subjects who are able to understand and follow the study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.

You may not qualify if:

• Subjects with hypersensitivity to deuremidevir hydrobromide for suspension or any of the excipients;
• Subjects with allergic diseases or allergic constitution;
• 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;
• Subjects with acute upper respiratory tract infection within 2 weeks before screening;
• Subjects who have received blood transfusion or used blood products within 3 months before screening or who have lost more than ≥400 mL of blood due to other reasons (except female physiological blood loss);
• Subjects who have participated in clinical trials of other drugs within 90 days before screening;
• Subjects who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 2 weeks before screening;
• Subjects who have consumed grapefruits, pomelos, oranges, etc. within the previous 7 days before screening and do not agree to stop consuming the above fruits and beverages during the trial period;
• Being a drug addict or alcohol addict within one year before screening,being an alcoholic at present or in the past (drinking more than 14 standard units per week, and one standard unit contains 14 g of alcohol,such as 360 mL of beer or 45 mL of strong liquor with 40% alcohol content or 150 mL of wine), or being positive in the alcohol breath tests;
• Subjects who smoked more than 5 cigarettes a day within one year before screening;
• Subjects who can't quit smoking or drinking during the trial period;
• 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);
• Abnormal chest X-ray or CT results with clinical significance;
• Pulse rate\>100 beats per minute, or systolic blood pressure ≥ 140 mmHg or\<90 mmHg, or diastolic blood pressure ≥ 90 mmHg or\<50 mmHg at screening or baseline;
• Total bilirubin (TBIL) \> upper limit of normal value (ULN), Alanine transaminase (ALT) or aspartate transaminase (AST) \> 1.5 times ULN at screening or baseline;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Hushan Hospital Fudan university

Shanghai, Shanghai Municipality, 201900, China

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Suspensions; GS-621763

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Xiaojie Wu

  Hushan Hospital Fudan university

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: March 27, 2024
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-02

Locations

CN (1)