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Respiratory Syncytial Virus InfectionsPhase 1NCT06328400

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

A Phase 1 study testing Deuremidevir Hydrobromide for Suspension in people with Respiratory Syncytial Virus Infections, run by Vigonvita Life Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
Deuremidevir Hydrobromide for Suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteChina
Study dates
27 Mar 2024to 6 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • The glomerular filtration rate (eGFR) < 90 ml/min at screening or baseline;
  • Any of the following blood routine examination results during screening or baseline were lower than the lower limit of normal: white blood cell count, absolute value of lymphocytes, percentage of lymphocytes, percentage of neutrophils, absolute value of neutrophils;
  • Abnormal ECG at screening or baseline, including QTcF (after heart rate correction) >450 ms for males and > 470 ms for females in single examinations, and/or other abnormalities with clinical significance;
  • Pregnant or lactating females, or male volunteers whose spouses have planned pregnancy within 3 months;
  • The investigator believes that there are other unsuitable factors for this volunteer to participate this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hushan Hospital Fudan university

    Shanghai, Shanghai Municipality, 201900

Other trials in China

About this study

Official title: A Multiple-dose, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension in Chinese Healthy Volunteers

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.

Read the detailed description

Two groups are initially set up, starting from Group 1 and progressing sequentially to Group 2. After all volunteers in the first group (900 mg BID group) complete the safety follow-up on the 4th day after the last dose (i.e. D10), the safety information and PK data will be reviewed jointly by the researchers and sponsors before the second group of volunteers starting administration. The preferred dose for the second group is 900 mg TID, and if there are safety risks found after the Group 1 study, it will be adjusted to 1200 mg BID or other appropriate dosage and frequency.

A total of 24 volunteers are planned to be enrolled, with 12 volunteers in each group. The trial drug and placebo will be allocated in a 3:1 ratio, with 9 volunteers in each group receiving the trial drug and 3 volunteers receiving placebo.

Being tested
Deuremidevir Hydrobromide for Suspension, Deuremidevir Hydrobromide for Suspension Placebo
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deuremidevir Hydrobromide for SuspensionDrug

    Also called VV116

    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

  • Deuremidevir Hydrobromide for Suspension PlaceboDrug

    Also called VV116 Placebo

    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

Study groups in NCT06328400
Study groupRoleWhat they receive
Deuremidevir Hydrobromide for Suspension 900mg group, twice a dayExperimental9 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.
Receives: Drug: Deuremidevir Hydrobromide for Suspension; Drug: Deuremidevir Hydrobromide for Suspension Placebo
Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a dayExperimental9 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.
Receives: Drug: Deuremidevir Hydrobromide for Suspension; Drug: Deuremidevir Hydrobromide for Suspension Placebo
Deuremidevir Hydrobromide for Suspension 1200mg group, twice a dayExperimental9 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.
Receives: Drug: Deuremidevir Hydrobromide for Suspension; Drug: Deuremidevir Hydrobromide for Suspension Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events

    Incidence of Treatment-Emergent Adverse Events

    Measured: From Day1 to Day10 after administration

Secondary outcomes (5)

  1. Cmax

    maximum observed plasma concentration

    Measured: 168 hours after administration

  2. Tmax

    time at which Cmax occurs

    Measured: 168 hours after administration

  3. AUC0- t

    area under the plasma concentration time curve from time zero to the last quantifiable concentration

    Measured: 168 hours after administration

  4. AUC0-∞

    area under the plasma concentration time curve from time zero to infinity

    Measured: 168 hours after administration

  5. t1/2

    terminal half life

    Measured: 168 hours after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2024
  2. Study start27 Mar 2024
  3. Primary completion6 May 2024
  4. Study completion6 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06328400
Sponsor's protocol ID
VV116-RSV-02
Status last verified
Feb 2024
First submitted
18 Mar 2024
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Deuremidevir Hydrobromide for Suspension in people with Respiratory Syncytial Virus Infections, run by Vigonvita Life Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: From Day1 to Day10 after administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06328400.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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