Healthy ParticipantsPhase 1NCT06533475

A Study to Assess the Bioavailability of a New Tablet Formulation of Minzasolmin and the Effect of Food in Healthy Participants

A Phase 1 study testing Minzasolmin tablet formulation under fasting condition, Minzasolmin Granules in capsule under fasting condition and Minzasolmin tablet formulation under fed condition in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in Germany.

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

The purpose of the study is to estimate the relative bioavailability of a new minzasolmin tablet formulation versus reference 'granules in capsule' formulation in healthy participants and to evaluate the effect of food with the new tablet formulation on the pharmacokinetics (PK) of minzasolmin. 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?: Minzasolmin tablet formulation under fasting condition, Minzasolmin Granules in capsule under fasting condition and Minzasolmin tablet formulation under fed condition
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteGermany
Study dates: 6 Sep 2024to 17 Nov 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Body weight within 45 to 100kg (female) and 50 to 100kg (male) and body mass index (BMI) within the range 18 to 30kg/m2 (inclusive).

Who cannot join

Participant has a history of chronic alcohol abuse (more than 24g [males] or 12g [females] per day; 12g pure alcohol are contained in approximately 300mL of beer (5%), 1 small glass [125 mL] of wine [12%], or 1 measure [40mL] of spirits [37.5%]) or drug abuse within the last 1 year from Screening, as defined according to the Diagnostic and Statistical Manual of Mental Disorders
Study participant has received or intends to use any prescription or nonprescription medicines, including enzyme inhibitors or inducers, any gastric pH modifying agents, over the counter remedies, herbal and dietary supplements (including St. John's Wort) up to 2 weeks (4 weeks for enzyme inducers) or 5 half-lives of the respective drug (whichever is longer) before the first administration of minzasolmin
Participant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device) within the previous 30 days or 5 half-lives, whichever is greatest, or is currently participating in another study of an IMP (and/or an investigational device)
Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN)
Participant has total bilirubin >1.0xULN. Bilirubin >ULN and ≤1.5xULN is acceptable if fractioned and direct bilirubin <35%, and if a baseline diagnosis of Gilbert's syndrome is understood and recorded in ClinBase
Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline, or a family history of sudden death due to long QT syndrome which, in the opinion of the investigator, would put the participant at increased risk of QT prolongation during the study

Show all 14Show fewer

In addition, any study participant with any of the following findings will be excluded at Screening:
QT interval corrected for heart rate using Fridericia's formula >450 msec for males and >470msec for females
other conduction abnormalities (defined as pulse rate [PR] interval ≥220ms)
irregular rhythm other than sinus arrhythmia or occasional, rare supraventricular, and rare ventricular ectopic beats
Study participant has a medical history or current diagnosis of renal impairment and/or Screening laboratory results show:
An estimated glomerular filtration rate <90 mL/min/1.73m2 (using the Chronic Kidney Disease Epidemiology Collaboration formula)
An albumin/creatinine ratio ≥30mg/mmol
Urinary tract infection; in this case a study participant can be rescreened once the infection has been resolved - Participant has donated blood or experienced blood loss >350mL within the last 1 month before the first IMP administration

Trial locations and contacts

1 site in 1 country.

Germany1 site

Up0152 1001
Berlin

Other trials in Germany

About this study

Official title: An Open-Label, Randomized Study to Evaluate the Relative Bioavailability of a New Tablet Formulation of Minzasolmin and the Potential Effect of Food on the Pharmacokinetics of Minzasolmin in Healthy Participants

Conditions: Healthy Participants
Being tested: Minzasolmin tablet formulation under fasting condition, Minzasolmin Granules in capsule under fasting condition, Minzasolmin tablet formulation under fed condition
Keywords: minzasolmin, Phase 1, Healthy Participants, Bioavailability

What participants receive

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

Minzasolmin tablet formulation under fasting conditionDrug
Also called UCB0599
Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition
Minzasolmin Granules in capsule under fasting conditionDrug
Also called UCB0599
Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition
Minzasolmin tablet formulation under fed conditionDrug
Also called UCB0599
Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition

Study groups in NCT06533475
Study group	Role	What they receive
Treatment A-B-C	Experimental	Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. A: Granules in capsule (fasting); B: Tablet formulation (fasting); C: Tablet formulation (fed). Receives: Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition
Treatment B-C-A	Experimental	Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. B: Tablet formulation (fasting); C: Tablet formulation (fed); A: Granules in capsule (fasting). Receives: Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition
Treatment C-A-B	Experimental	Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. C: Tablet formulation (fed); A: Granules in capsule (fasting); B: Tablet formulation (fasting). Receives: Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition
Treatment A-C-B	Experimental	Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. A: Granules in capsule (fasting); C: Tablet formulation (fed); B: Tablet formulation (fasting). Receives: Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition
Treatment B-A-C	Experimental	Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. B: Tablet formulation (fasting); A: Granules in capsule (fasting); C: Tablet formulation (fed). Receives: Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition
Treatment C-B-A	Experimental	Participants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. C: Tablet formulation (fed); B: Tablet formulation (fasting); A: Granules in capsule (fasting). Receives: Drug: Minzasolmin tablet formulation under fasting condition; Drug: Minzasolmin Granules in capsule under fasting condition; Drug: Minzasolmin tablet formulation under fed condition

What is being measured

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

Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC[0-t]) for Minzasolmin
AUC0-t was defined as the area under the plasma concentration-time curve from time zero to the last measurable drug concentration sampling time for Minzasolmin.
Measured: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hour (h) post dose on Day 1, Day 6, and Day 11
Area Under the Plasma Concentration-time Curve From Zero to Infinity for Minzasolmin
AUC was defined as the area under the plasma concentration-time curve from time zero to infinity for Minzasolmin.
Measured: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11
Maximum Plasma Concentration (Cmax) of Minzasolmin
Cmax was defined as the maximum (peak) observed drug concentration following a single dose administration of Minzasolmin.
Measured: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11

Secondary outcomes (3)

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
Measured: From Baseline to end of Safety Follow-Up, up to 48 days
Percentage of Participants With Serious Treatment-emergent Adverse Events (TEAEs)
An SAE was defined as any untoward medical occurrence that, at any dose, met 1 or more of the criteria listed:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- Important medical events such as (but not limited to) invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias, convulsions not resulting in hospitalization, or development of intervention dependency or intervention abuse.
Measured: From Baseline to end of Safety Follow-Up, up to 48 days
Percentage of Participants With TEAEs Leading to Withdrawal From Study
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were all AEs starting on or after the date/time of first treatment and up to including 4 days after last treatment, or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. Percentage of participants with TEAEs leading to withdrawal from study were reported.
Measured: From Baseline to end of Safety Follow-Up, up to 48 days

Timeline

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

6 Sep 202417 Nov 2024

First posted1 Aug 2024
Study start6 Sep 2024
Primary completion17 Nov 2024
Study completion17 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06533475
Sponsor's protocol ID: UP0152
Other IDs: 2024-511301-31-00, U1111-1306-5483
Status last verified: Nov 2025
First submitted: 29 Jul 2024
Last updated: 26 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized Study to Evaluate the Relative Bioavailability of a New Tablet Formulation of Minzasolmin and the Potential Effect of Food on the Pharmacokinetics of Minzasolmin in Healthy Participants
ClinicalTrials.gov ID: NCT06533475
Acronym / sponsor ID: UP0152
Conditions: Healthy Participants
Keywords: minzasolmin, Phase 1, Healthy Participants, Bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: UCB Biopharma SRLIndustry (pharma, biotech, devices)
Study start: 6 Sep 2024 (actual)
Primary completion: 17 Nov 2024 (actual)
Study completion: 17 Nov 2024 (actual)
First posted: 1 Aug 2024 (actual)
Results: Posted 26 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment A-B-C	Experimental	Drug: Minzasolmin tablet formulation under fasting condition, Drug: Minzasolmin Granules in capsule under fasting condition, Drug: Minzasolmin tablet formulation under fed conditionParticipants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. A: Granules in capsule (fasting); B: Tablet formulation (fasting); C: Tablet formulation (fed).
Treatment B-C-A	Experimental	Drug: Minzasolmin tablet formulation under fasting condition, Drug: Minzasolmin Granules in capsule under fasting condition, Drug: Minzasolmin tablet formulation under fed conditionParticipants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. B: Tablet formulation (fasting); C: Tablet formulation (fed); A: Granules in capsule (fasting).
Treatment C-A-B	Experimental	Drug: Minzasolmin tablet formulation under fasting condition, Drug: Minzasolmin Granules in capsule under fasting condition, Drug: Minzasolmin tablet formulation under fed conditionParticipants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. C: Tablet formulation (fed); A: Granules in capsule (fasting); B: Tablet formulation (fasting).
Treatment A-C-B	Experimental	Drug: Minzasolmin tablet formulation under fasting condition, Drug: Minzasolmin Granules in capsule under fasting condition, Drug: Minzasolmin tablet formulation under fed conditionParticipants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. A: Granules in capsule (fasting); C: Tablet formulation (fed); B: Tablet formulation (fasting).
Treatment B-A-C	Experimental	Drug: Minzasolmin tablet formulation under fasting condition, Drug: Minzasolmin Granules in capsule under fasting condition, Drug: Minzasolmin tablet formulation under fed conditionParticipants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. B: Tablet formulation (fasting); A: Granules in capsule (fasting); C: Tablet formulation (fed).
Treatment C-B-A	Experimental	Drug: Minzasolmin tablet formulation under fasting condition, Drug: Minzasolmin Granules in capsule under fasting condition, Drug: Minzasolmin tablet formulation under fed conditionParticipants will be randomized to receive single doses of minzasolmin with and without food on different Days with a 4-day Washout Period between doses. C: Tablet formulation (fed); B: Tablet formulation (fasting); A: Granules in capsule (fasting).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Body weight within 45 to 100kg (female) and 50 to 100kg (male) and body mass index (BMI) within the range 18 to 30kg/m2 (inclusive).

Key exclusion criteria (14 listed)

Participant has a history of chronic alcohol abuse (more than 24g [males] or 12g [females] per day; 12g pure alcohol are contained in approximately 300mL of beer (5%), 1 small glass [125 mL] of wine [12%], or 1 measure [40mL] of spirits [37.5%]) or drug abuse within the last 1 year from Screening, as defined according to the Diagnostic and Statistical Manual of Mental Disorders
Study participant has received or intends to use any prescription or nonprescription medicines, including enzyme inhibitors or inducers, any gastric pH modifying agents, over the counter remedies, herbal and dietary supplements (including St. John's Wort) up to 2 weeks (4 weeks for enzyme inducers) or 5 half-lives of the respective drug (whichever is longer) before the first administration of minzasolmin
Participant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device) within the previous 30 days or 5 half-lives, whichever is greatest, or is currently participating in another study of an IMP (and/or an investigational device)
Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN)
Participant has total bilirubin >1.0xULN. Bilirubin >ULN and ≤1.5xULN is acceptable if fractioned and direct bilirubin <35%, and if a baseline diagnosis of Gilbert's syndrome is understood and recorded in ClinBase

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
Minzasolmin tablet formulation under fasting conditionAlso: UCB0599Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fasting condition	Drug	Treatment A-B-C, Treatment A-C-B, Treatment B-A-C, Treatment B-C-A, Treatment C-A-B, Treatment C-B-A
Minzasolmin Granules in capsule under fasting conditionAlso: UCB0599Drug: Minzasolmin Pharmaceutical form: Granules in capsule under fasting condition	Drug	Treatment A-B-C, Treatment A-C-B, Treatment B-A-C, Treatment B-C-A, Treatment C-A-B, Treatment C-B-A
Minzasolmin tablet formulation under fed conditionAlso: UCB0599Drug: Minzasolmin Pharmaceutical form: Tablet formulation under fed condition	Drug	Treatment A-B-C, Treatment A-C-B, Treatment B-A-C, Treatment B-C-A, Treatment C-A-B, Treatment C-B-A

Primary outcome

Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC[0-t]) for Minzasolmin
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hour (h) post dose on Day 1, Day 6, and Day 11
AUC0-t was defined as the area under the plasma concentration-time curve from time zero to the last measurable drug concentration sampling time for Minzasolmin.
Area Under the Plasma Concentration-time Curve From Zero to Infinity for Minzasolmin
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11
AUC was defined as the area under the plasma concentration-time curve from time zero to infinity for Minzasolmin.
Maximum Plasma Concentration (Cmax) of Minzasolmin
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11
Cmax was defined as the maximum (peak) observed drug concentration following a single dose administration of Minzasolmin.

3 secondary outcomes

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Baseline to end of Safety Follow-Up, up to 48 days
Percentage of Participants With Serious Treatment-emergent Adverse Events (TEAEs)
Time frame: From Baseline to end of Safety Follow-Up, up to 48 days
Percentage of Participants With TEAEs Leading to Withdrawal From Study
Time frame: From Baseline to end of Safety Follow-Up, up to 48 days

Results and safety

Results posted to the registry on 26 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment ABC	3	3
Treatment BCA	3	3
Treatment CAB	3	3
Treatment ACB	3	3
Treatment BAC	3	3
Treatment CBA	3	3

Primary outcome: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC[0-t]) for Minzasolmin

Time frame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hour (h) post dose on Day 1, Day 6, and Day 11. Geometric mean (Geometric Coefficient of Variation). Unit: hour*nanograms per milliliter (h*ng/mL)

Measure	Minzasolmin Capsule (Fasted) n = 18	Minzasolmin Tablet (Fasted) n = 18	Minzasolmin Tablet (Fed) n = 18
Value	5612 (34.6)	5710 (35.5)	6140 (34.2)

Minzasolmin Capsule (Fasted) vs Minzasolmin Tablet (Fasted): GLSM Ratio: 1.018 (90% CI 0.9624 to 1.076)
Minzasolmin Tablet (Fasted) vs Minzasolmin Tablet (Fed): GLSM Ratio: 1.075 (90% CI 1.024 to 1.130)

Population analysed: The Pharmacokinetics (PK) Set consisted of all study participants in the safety set (SS) who had at least 1 observable PK concentration data point and who had no important protocol deviations affecting the PK during the study.

Primary outcome: Area Under the Plasma Concentration-time Curve From Zero to Infinity for Minzasolmin

Time frame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Minzasolmin Capsule (Fasted) n = 18	Minzasolmin Tablet (Fasted) n = 18	Minzasolmin Tablet (Fed) n = 18
Value	5656 (34.3)	5769 (35.5)	6190 (33.9)

Minzasolmin Capsule (Fasted) vs Minzasolmin Tablet (Fasted): GLSM Ratio: 1.020 (90% CI 0.9649 to 1.078)
Minzasolmin Tablet (Fasted) vs Minzasolmin Tablet (Fed): GLSM Ratio: 1.073 (90% CI 1.021 to 1.127)

Population analysed: The PK set consisted of all study participants in the SS who had at least 1 observable PK concentration data point and who had no important protocol deviations affecting the PK during the study.

Primary outcome: Maximum Plasma Concentration (Cmax) of Minzasolmin

Time frame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 h post dose on Day 1, Day 6, and Day 11. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per mililiter (ng/mL)

Measure	Minzasolmin Capsule (Fasted) n = 18	Minzasolmin Tablet (Fasted) n = 18	Minzasolmin Tablet (Fed) n = 18
Value	627.2 (45.9)	612.9 (54.8)	622.5 (30.9)

Minzasolmin Capsule (Fasted) vs Minzasolmin Tablet (Fasted): GLSM Ratio: 0.9771 (90% CI 0.7966 to 1.199)
Minzasolmin Tablet (Fasted) vs Minzasolmin Tablet (Fed): GLSM Ratio: 1.016 (90% CI 0.7940 to 1.299)

Population analysed: PK set consisted of all study participants in the SS who had at least 1 observable PK concentration data point and who had no important protocol deviations affecting the PK during the study.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to end of Safety Follow-Up, up to 48 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Minzasolmin Capsule (Fasted)	0 of 18 (0%)	3 of 18 (16.7%)	0 of 18
Minzasolmin Tablet (Fasted)	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18
Minzasolmin Tablet (Fed)	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 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 26 Nov 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 Germany. 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?

Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC[0-t]) for Minzasolmin (time frame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hour (h) post dose on Day 1, Day 6, and Day 11). The study lists 3 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 NCT06533475.

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 26 Nov 2025.