Healthy ParticipantsPhase 1NCT07035769
A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults
A Phase 1 study testing Debio 1453P in people with Healthy Participants, run by Debiopharm International SA at 1 site in Belgium.
Trial summary
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Debio 1453P
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Jun 2025to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed and dated written informed consent obtained before undertaking any trial-specific procedures.
- Be within the age range of 18 to 55 years, inclusive, at the time of screening.
- Have a body mass index (BMI) ≥18.5 and ≤30.0 kg/m^2.
Who cannot join
- History and/or physical examination evidence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, immunological, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk for taking part in the trial, influence the results of the trial, influence the participant's ability to take part in the trial.
- Any medication (including vaccines, over the counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal participants) for 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first administration of trial drug (except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks).
- History of chronic drug or alcohol abuse (defined as an average intake of more than 21 units of alcohol per week for males and 14 for females. 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) in the last 2 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
SGS Belgium NV - Clinical Pharmacology Unit
Edegem, 2650
About this study
Official title: A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.
- Conditions
- Healthy Participants
- Being tested
- Debio 1453P, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debio 1453PDrug
Powder for oral solution
PlaceboDrug
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single ascending dose (SAD) | Experimental | Participants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1. Receives: Drug: Debio 1453P; Drug: Placebo |
| Part 2: Multiple ascending dose (MAD) | Experimental | Participants will receive multiple oral doses of Debio 1453P or placebo from Day 1 to Day 5. Debio 1453P initial dose in this part will be based on available data from SAD part. Receives: Drug: Debio 1453P; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 15 months
Secondary outcomes (2)
Plasma Concentration of Debio 1453P
The PK of Debio 1453P will be evaluated in plasma.
Measured: Pre-dose and at multiple timepoints post-dose up to Day 12
Urine Concentration of Debio 1453P
The PK of Debio 1453P will be evaluated in urine.
Measured: Pre-dose and at multiple timepoints post-dose up to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start18 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, Wellcome Trust, Germany's Federal Ministry of Research, Technology and Space (BMFTR), Global Antimicrobial Resistance Innovation Fund-(GAMRIF), Novo Nordisk Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035769
- Sponsor's protocol ID
- Debio 1453-101
- Other IDs
- 2024-519328-26, U1111-1315-2035, 75A50122C00028, 224842/Z/21/Z, NNF23SA0088536, Agreement Dated 1/30/2023, Agreement Dated 2/28/2023
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults
- ClinicalTrials.gov ID
- NCT07035769
- Acronym / sponsor ID
- Debio 1453-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, Wellcome Trust, Germany's Federal Ministry of Research, Technology and Space (BMFTR), Global Antimicrobial Resistance Innovation Fund-(GAMRIF), Novo Nordisk Foundation
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single ascending dose (SAD) | Experimental | Drug: Debio 1453P, Drug: PlaceboParticipants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1. |
| Part 2: Multiple ascending dose (MAD) | Experimental | Drug: Debio 1453P, Drug: PlaceboParticipants will receive multiple oral doses of Debio 1453P or placebo from Day 1 to Day 5. Debio 1453P initial dose in this part will be based on available data from SAD part. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed and dated written informed consent obtained before undertaking any trial-specific procedures.
- Be within the age range of 18 to 55 years, inclusive, at the time of screening.
- Have a body mass index (BMI) ≥18.5 and ≤30.0 kg/m^2.
Key exclusion criteria (3 listed)
- History and/or physical examination evidence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, immunological, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk for taking part in the trial, influence the results of the trial, influence the participant's ability to take part in the trial.
- Any medication (including vaccines, over the counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal participants) for 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first administration of trial drug (except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks).
- History of chronic drug or alcohol abuse (defined as an average intake of more than 21 units of alcohol per week for males and 14 for females. 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) in the last 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debio 1453PPowder for oral solution | Drug | Part 1: Single ascending dose (SAD), Part 2: Multiple ascending dose (MAD) |
| PlaceboOral solution | Drug | Part 1: Single ascending dose (SAD), Part 2: Multiple ascending dose (MAD) |
Primary outcome
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 15 months
2 secondary outcomes
Plasma Concentration of Debio 1453P
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 12
Urine Concentration of Debio 1453P
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Debio 1453P in people with Healthy Participants, run by Debiopharm International SA at 1 site in Belgium.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debiopharm International S.A (+41213210111, clinicaltrials@debiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.