A Phase 1 interventional study of Phelimin in Phenylketonuria (PKU) and Phenylketonuria, sponsored by MipSalus Aps. Not yet recruiting at 1 site in Denmark. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by MipSalus Aps · Phase 1, Interventional, and Treatment
This first-in-human study will evaluate the safety and tolerability of phelimin, an investigational oral treatment being developed for people with phenylketonuria (PKU). Phelimin is designed to bind the amino acid phenylalanine in the gut, which may reduce its absorption from food and support its removal from the body in stool. The study will include healthy volunteers and adults with classical PKU. Participants will receive single doses of phelimin at increasing dose levels and will undergo safety assessments, including monitoring for side effects, laboratory tests, and gastrointestinal symptoms. The study will also explore whether phelimin affects blood phenylalanine levels after a standardised protein challenge.
191 studies on the registry are indexed under Phenylketonurias; 40 are open to participants now.
This study's planned enrollment of 7 is below the median of 27 across 122 interventional studies indexed under Phenylketonurias.
Browse Phenylketonurias studies →This is the only study on the registry with MipSalus Aps as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
COMMON FOR BOTH PARTICIPANT GROUPS
i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
For HEALTHY VOLUNTEERS h. Good health in the opinion of the Investigator based on medical history, physical examination, vital signs, (ECG) and laboratory measurements of standard blood and urine parameters.
For PKU PATIENTS i. Diagnosis of classical PKU based on medical history (genotyping and/or p-Phe concentration >1200 μmol/L at any time in life).
j. Currently, and prior to screening, reasonably well controlled (see below) on low protein diet; with no single p-Phe measurement >1200 μmol/L during last 3 months prior to screening k. Within study, p-Phe ≤900 μmol/L taken in the clinic at screening and confirmed at the baseline visit (visit 2) prior to protein challenge and at the 'Day -3' sampling prior to each clinic visit l. With the exception of the underlying PKU diagnosis, good health in the opinion of the Investigator based on medical history, physical examination, vital signs, ECG and laboratory measurements of standard blood and urine parameters.
Exclusion Criteria:
COMMON
Abnormal liver function tests defined by:
Is unable, in the opinion of the investigator, to comply with the requirements of the study.
For PKU PATIENTS, only
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Phelimin
Phelimin is an orally administered investigational medicinal product based on molecular imprinted polymer technology designed to bind phenylalanine and phenylalanine-containing oligopeptides in the GI tract, facilitating their elimination without systemic absorption.
Treatment-Emergent Adverse Events
* Frequency of any TEAEs * Frequency of any TEAE by system organ class (SOC), * Frequency of any TEAE by preferred term (PT), * Frequency of any TEAE by severity, and * Frequency of any TEAE by relationship of TEAEs to IMP.
Time frame: From enrollment to 4 weeks after last dose.
AEs
* Frequency of any AE * Frequency of any AE by SOC, * Frequency of any AE by PT, * Frequency of any AE by severity, and * Frequency of any AE by relationship of AEs to IMP.
Time frame: From enrollment to 4 weeks after last dose
Serious adverse events (SAE)
* Frequency of any SAE * Frequency of any SAE by SOC, * Frequency of any SAE by PT, * Frequency of any SAE by severity and * Frequency of any SAE by relationship of SAEs to IMP.
Time frame: From enrollment to 4 weeks after the last dose.
Adverse Events of Special Interest (AESIs; related to GI symptoms)
* Frequency of any AESI * Frequency of any AESIs by SOC, * Frequency of any AESIs by PT, * Frequency of any AESIs by severity, and * Frequency of any AESIs by relationship of AESIs to IMP.
Time frame: From enrollment to 4 weeks after last dose.
Discontinuation rate
* Overall * Due to TEAEs
Time frame: From enrollment to 4 weeks after last dose.
Safety laboratory variables
For each safety laboratory variable: * Frequency of below normal range (clinically significant) * Frequency of below normal range (not clinically significant) * Frequency of within normal range * Frequency of above normal range (not clinically significant) * Frequency of above normal range (clinically significant)
Time frame: From enrollment to 4 weeks after last dose
To investigate other aspects related to tolerability
For the vital signs parameters: systolic blood pressure, diastolic blood pressure. Measured values will be presented descriptively with means per dosing cohort. Any significant intraindividual changes between study visits will be tabulated.
Time frame: From enrolment to 4 weeks after last dose
To investigate other aspects related to tolerability
For the vital signs parameters: Heart rate. Measured values will be presented descriptively with means per dosing cohort. Any significant intraindividual changes between study visits will be tabulated.
Time frame: From enrolment to 4 weeks after last dose
To investigate other aspects related to tolerability
For the vital signs parameters: Body temperature. Measured values will be presented descriptively with means per dosing cohort. Any significant intraindividual changes between study visits will be tabulated.
Time frame: From enrolment to 4 weeks after last dose
To investigate other aspects related to tolerability
For the vital signs parameters: Respiration rate. Measured values will be presented descriptively with means per dosing cohort. Any significant intraindividual changes between study visits will be tabulated.
Time frame: From enrolment to 4 weeks after last dose
To investigate other aspects related to tolerability
Body weight (kg). Measured values will be presented descriptively with means per dosing cohort. Any significant intraindividual changes between study visits will be tabulated.
Time frame: From enrolment to 4 weeks after last dose
To investigate other aspects related to tolerability
Physical examinations: Any new findings or changes to previous findings considered to be clinically significant will be tabulated.
Time frame: From enrollment until 4 weeks after last dose
Plasma concentration of each of the AAs in the total amino acids (tAA)
* Area-Under-the-Curve (AUC) from baseline to each time-point * Plasma concentration fluctuations
Time frame: From enrollment to 4 weeks after last dose
Plasma concentration of each of the AAs in the total amino acids (tAA)
* Maximum plasma concentration (Cmax) * Plasma concentration fluctuations
Time frame: From enrollment to 4 weeks after last dose
Evaluate palatability of the phelimin formulation
Participant reported assessment of palatability attributes following administration of phelimin, measured using a five category Likert scale with response options: great, good, OK, bad, and terrible.
Time frame: 1 hour after each administration of study intervention, from enrollment to 4 weeks after last dose
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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