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Healthy VolunteerPhase 1NCT06721091

Safety, Tolerability, and Dose Response of VNA-318 in Healthy Males

A Phase 1 study testing VNA-318 in people with Healthy Volunteer, run by VANDRIA at 1 site in France.

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 is a phase 1, randomized, double-blind, placebo-controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) and multiple ascending doses (MAD) of VNA-318 in healthy male subjects. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
VNA-318
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
1 siteFrance
Study dates
3 Dec 2024to 27 Nov 2025
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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects able and willing to provide written informed consent prior any other clinical study procedures.
  • Subjects able and willing to comply with the clinical study protocol (hospitalization periods, scheduled visits, IMP administration, clinical laboratory tests, and other study procedures including lifestyle considerations) according to International Council of Harmonization (ICH) and local regulations.
  • Demography
  • Healthy male.
  • Aged 18-65 years (inclusive) on the day of signing the informed consent form (ICF). - Aged 18-45 years (inclusive) for the SAD optional exploratory cohort with CSF sampling
  • Have a body mass index (BMI) between 18.5-30.0 kg/m2 (inclusive) at screening and D 1.
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  • Health Status
  • Have normal physical examination and vital signs (VS) results within normal ranges at screening and D˗1. If outside normal ranges, it must be considered by the Investigator without clinically significant abnormal findings.
  • Have a clinical laboratory of blood and urine within normal ranges at screening and D-1. If outside normal ranges, it must be considered by the Investigator without clinically significant abnormal findings.
  • Have 12-lead ECG results without clinically significant abnormal findings confirmed by the Investigator at screening and D-1.
  • Non-smoker (and no other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (< 200 ng/mL) at screening and D-1.
  • Contraception
  • If sexually active and not sterile, with a woman of childbearing potential, the subject and his partner must commit to using a highly effective method of birth control starting at screening and throughout the entire study and for 90 days after last dose of IMP administration:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, started at least 4 weeks prior to the dosing (D1) and use of condom for the male partner.
  • Progestogen-only hormonal contraception associated with inhibition of ovulation, started at least 4 weeks prior to the dosing (D1) and use of condom for the male partner.
  • Intrauterine device placed at least 4 weeks prior to the dosing (D1), and use of condom for the male partner.
  • Intrauterine hormone-releasing system placed at least 4 weeks prior to the dosing (D1), and use of condom for the male partner.
  • Simultaneous use of a diaphragm or cervical cap with intravaginally applied spermicide and, for the male partner, a male condom.
  • Sexual abstinence (when in line with the preferred and usual subject's lifestyle).
  • Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
  • Or subject with a male partner.
  • Male subjects must agree to abstain from sperm donation starting at screening and throughout the study and for 90 days following their last dose of IMP administration.
  • Regulations
  • Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
  • Have competence in speaking, writing, and comprehending the local language(s) where the study is conducted.

Who cannot join

  • Medical History
  • Any condition or disease detected during the medical interview/physical examination that could relapse during or immediately after the study, or would render the subject unsuitable for the study, place the subject at undue risk, or interfere with the ability of the subject to complete the clinical study, as determined by the Investigator.
  • Have a history of and/or current clinically significant disease/disorder determined by the Investigator: gastrointestinal, endocrine, renal, hepatic, immunological, cardiovascular, hematological, respiratory, neurologic, metabolic, urologic, dermatologic, psychiatric disorder, or allergic disease, hypersensitivity, or allergic reactions excluding mild asymptomatic seasonal allergies (either spontaneous or following drug administration), or malignancy (including lymphoma, leukemia, and skin cancer) unless remission over 10 years.
  • Have a personal or family history of prolonged QT interval syndrome or Torsade de Pointes, or family history of sudden death.
  • Have current presence of an illness, such as a common cold, isolated headache, diarrhea, etc., within 14 days prior to D1 that is categorized as clinically significant by the Investigator.
  • History or presence of regular use of recreational or illicit drugs within 1 year before study D1.
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  • Donation of blood or blood loss (i.e., > 450 ml) within 90 days, or donated plasma within 7 days prior to D-1.
  • Known significant hypersensitivity or other contraindication to any of the components of the study drug.
  • History of suicidal behavior or any risk of suicidal behavior in the opinion of a certified clinician or as evidenced by a "yes" to any questions of Columbia-Suicide Severity Rating Scale (C-SSRS) taken at screening (MAD part only).
  • Confirmed coronavirus disease 2019 (COVID-19) infection within 90 days of screening or contact with an individual with COVID-19 infection in the past 14 days at D-1.
  • Physical and Laboratory Findings
  • Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus 1 and/or 2 antibodies (anti-HIV1 and anti HIV2 Ab) at screening.
  • Positive findings of urine drug screen (methadone, barbiturates, morphine, amphetamines, methamphetamines, opiates (including morphine), cannabinoids, cocaine, benzodiazepines, tricyclic antidepressants (TCA), 3,4-methylenedioxy-methamphetamine [MDMA; ecstasy]).
  • Have a positive alcohol breath test result at screening or D-1.
  • Lifestyle restrictions
  • Have regular consumption of grapefruit juice and any xanthine-containing products (e.g., coffee, tea, chocolate, or Coca-Cola like drinks) more than 6 cups per day (or equivalent), or consumption of any alcoholic beverages within 48 h before prior dosing (D1) until final discharge day inclusive.
  • Have regular consumption of alcoholic beverages that exceeds 21 units per week (1 unit = 10 g of pure alcohol).
  • Prior/Concurrent Clinical Study Experience
  • Participation in any another interventional study within ≤90 days prior to Screening provided that the clinical study did not entail administration of a biological compound with a long terminal phase half-life (t½), or in the exclusion period of a previous trial or participation in more than 3 clinical studies within the last 12 months.
  • Prohibited Treatments
  • Use of any prescribed or non-prescribed drugs (including vitamins, herbal and dietary supplements, e.g., St. John's Wort) within 2 weeks or 5 half-lives, whichever is longer, prior to study drug administration, except for the occasional use of acetaminophen (up to 3 g/day).
  • Other Exclusions
  • Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
  • Subject is employed by Sponsor, the CRO, or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family (i.e., a spouse, parent, sibling, or child, whether biological or legally adopted) of Sponsor, CRO, or study site employee.
  • Prisoners or subjects who are legally institutionalized and with right's restrictions.
  • For Part 1 SAD optional exploratory cohort with CSF sampling only:
  • Platelets and coagulation results within normal ranges.
  • Any medical history that could contraindicate a lumbar puncture [such as spinal trauma, scoliosis, regular headaches (non-exhaustive list)].
  • Use of aspirin or any anticoagulant medication within 3 weeks prior to CSF sampling

Trial locations and contacts

1 site in 1 country.

France1 site

  • Biotrial

    Rennes, 35000

Other trials in France

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of VNA-318 in Healthy Male Subjects

This is a phase 1, randomized, double-blind, placebo-controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) and multiple ascending doses (MAD) of VNA-318 in healthy male subjects.

Read the detailed description

The First-in-Human phase I, single center study investigating VNA-318, administered orally, will consist of 2 parts:

  • Part 1 SAD, conducted in 5 to 8 cohorts of 8 healthy male subjects per dose level, including one optional exploratory cohort with cerebrospinal fluid (CSF) sampling
  • Part 2 MAD, conducted in 3 to 4 cohorts of 12 healthy male subjects per dose level Subjects will be included in either Part 1 or 2.

A Study Safety Committee is involved and will make recommendations on the study advancement, i.e. the dose for the next planned cohort.

The doses of the MAD part will be selected by this Study Safety Committee and will be based upon safety and tolerability assessments, the observed PK and, if available and applicable, PD data from SAD.

Being tested
VNA-318, Placebo

What participants receive

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

  • VNA-318Drug

    Part 1 will consist of administration of VNA-318 at the doses of 5 mg to 180 mg in 5 to 8 successive cohorts.

    Part 2 will consist of administration of VNA-318 in 3 to 4 successive cohorts. The doses will be selected based on safety and tolerability assessments, as well as PK and, if applicable, PD data from SAD.

    Once PK suggests that the therapeutic dose has been reached in the SAD part, the SAD and MAD parts of the study could be run in parallel.

  • PlaceboDrug

    Part 1 (SAD) will consist of administration of matching placebo at the doses of 5 mg to 180 mg in 5 to 8 successive cohorts.

    Part 2 (MAD) will consist of administration of matching placebo in 3 to 4 successive cohorts. The doses will be selected based on safety and tolerability assessments, as well as PK and, if applicable, PD data from SAD.

Study groups in NCT06721091
Study groupRoleWhat they receive
Part 1 (SAD): ActiveExperimentalSingle oral dose of VNA-318
Receives: Drug: VNA-318
Part 1 (SAD): PlaceboPlacebo comparatorSingle oral dose of Matching Placebo
Receives: Drug: Placebo
Part 2 (MAD): ActiveExperimentalMultiple oral doses of VNA-318
Receives: Drug: VNA-318
Part 2 (MAD): PlaceboPlacebo comparatorMultiple oral doses of Matching Placebo
Receives: Drug: Placebo

What is being measured

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

  1. Safety and tolerability of single dose

    • Percentage of subjects who experienced at least one treatment-emergent adverse event (TEAE) by seriousness, intensity, and relatedness from baseline through follow-up,

    Measured: From Day 1 to Day 7

  2. Safety and tolerability of single dose

    • Percentage of subjects who discontinued due to a TEAE,

    Measured: From Day 1 to Day 7

  3. Safety and tolerability of single dose

    • Percentage of subjects who met the abnormal criteria for safety laboratory tests at least once post-dose,

    Measured: From Day 1 to Day 7

  4. Safety and tolerability of single dose

    • Percentage of subjects who met the abnormal criteria for vital signs (blood pressure, pulse rate, and body temperature) measurement at least once post-dose,

    Measured: From Day 1 to Day 7

  5. Safety and tolerability of single dose

    • Percentage of subjects who meet the abnormal criteria for safety electrocardiogram (ECG) parameters at least once post-dose.

    Measured: From Day 1 to Day 7

  6. Safety and tolerability of multiple dose

    • Percentage of subjects who experienced at least one treatment-emergent adverse event (TEAE) by seriousness, intensity, and relatedness from baseline through follow-up,

    Measured: From Day 1 to Day 19

  7. Safety and tolerability of multiple dose

    • Percentage of subjects who discontinued due to a TEAE,

    Measured: From Day 1 to Day 19

  8. Safety and tolerability of multiple dose

    • Percentage of subjects who met the abnormal criteria for safety laboratory tests at least once post-dose,

    Measured: From Day 1 to Day 19

  9. Safety and tolerability of multiple dose

    • Percentage of subjects who met the abnormal criteria for vital signs (blood pressure, pulse rate, and body temperature) measurement at least once post-dose,

    Measured: From Day 1 to Day 19

  10. Safety and tolerability of multiple dose

    • Percentage of subjects who meet the abnormal criteria for safety electrocardiogram (ECG) parameters at least once post-dose.

    Measured: From Day 1 to Day 19

Secondary outcomes (21)

  1. SAD - Cmax

    Maximum observed plasma concentration (Cmax)

    Measured: Day 1

  2. SAD tmax

    Time to reach maximum observed plasma concentration (tmax)

    Measured: Day 1

  3. SAD Clast

    Last observed quantifiable concentration (Clast)

    Measured: Day 1

  4. SAD Tlast

    Time to reach last observed quantifiable concentration (Tlast)

    Measured: Day 1

  5. SAD AUC0-inf

    Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)

    Measured: Day 1

  6. SAD AUC0-t

    Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

    Measured: Day 1

  7. SAD ke

    Apparent terminal elimination rate constant (ke)

    Measured: Day 1

  8. SAD t½

    Terminal elimination half-life (t½)

    Measured: Day 1

  9. SAD CL/F

    Total body clearance (CL/F)

    Measured: Day 1

  10. SAD Vz/F

    Volume of distribution (Vz/F)

    Measured: Day 1

  11. MAD Cmax

    Maximum observed plasma concentration (Cmax)

    Measured: Day 1 and Day 12

  12. MAD tmax

    Time to reach maximum observed plasma concentration (tmax)

    Measured: Day 1 and Day 12

  13. MAD Ctrough

    Trough concentration at the end of the dosing interval (Ctrough)

    Measured: Day 1 and Day 12

  14. MAD AUC0-24h

    Area under the plasma concentration-time curve from time zero to 24h (AUC0-24h)

    Measured: Day 1 and Day 12

  15. MAD AUC0-inf

    Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)

    Measured: Day 1 and Day 12

  16. MAD ke

    Terminal elimination constant rate (ke)

    Measured: Day 1 and Day 12

  17. MAD t½

    Terminal elimination half-life (t½)

    Measured: Day 1 and Day 12

  18. MAD CL/F

    Total body clearance (CL/F)

    Measured: Day 1 and Day 12

  19. Characterize MAD PK profiles of VNA-318

    Volume of distribution (Vz/F)

    Measured: Day 1 and Day 12

  20. MAD Vss

    Apparent volume of distribution at steady-state (Vss)

    Measured: Day 12

  21. MAD accumulation ratio

    Accumulation ratio calculated from Cmax at steady state and Cmax after first dosing (Rac(Cmax)) as well as from AUC (Rac(AUC(0-24h))

    Measured: Day 12

Timeline

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

  1. First posted6 Dec 2024
  2. Study start3 Dec 2024
  3. Primary completion27 Nov 2025
  4. Study completion27 Nov 2025

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
Other
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06721091
Sponsor's protocol ID
VNA-318-01
Status last verified
Dec 2025
First submitted
20 Nov 2024
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VNA-318 in people with Healthy Volunteer, run by VANDRIA at 1 site in France.

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 25 inclusion and 29 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 10 Dec 2025. 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 France. 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. Some participants in this study may receive a placebo. 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?

Safety and tolerability of single dose (time frame: From Day 1 to Day 7). The study lists 10 primary outcomes in all. 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 NCT06721091.

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 10 Dec 2025.

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