A First-in-Human Study of Phelimin in Healthy Volunteers and Adults With PKU
NCT07927608, Phase 1, Not yet recruiting, MipSalus Aps
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A First-in-Human Study of Phelimin in Healthy Volunteers and Adults With PKU | ClinicalTrials.gov |
| NCT number | NCT07927608 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 7 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | MipSalus Aps | ClinicalTrials.gov |
| Conditions | Phenylketonuria (PKU), Phenylketonuria | ClinicalTrials.gov |
| Interventions | Phelimin | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Treatment-Emergent Adverse Events | From enrollment to 4 weeks after last dose. | * 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. | ClinicalTrials.gov |
| Primary | AEs | From enrollment to 4 weeks after last dose | * 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. | ClinicalTrials.gov |
| Primary | Serious adverse events (SAE) | From enrollment to 4 weeks after the last dose. | * 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. | ClinicalTrials.gov |
| Secondary | Adverse Events of Special Interest (AESIs; related to GI symptoms) | From enrollment to 4 weeks after last dose. | * 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. | ClinicalTrials.gov |
| Secondary | Discontinuation rate | From enrollment to 4 weeks after last dose. | * Overall * Due to TEAEs | ClinicalTrials.gov |
| Secondary | Safety laboratory variables | From enrollment to 4 weeks after last dose | 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) | ClinicalTrials.gov |
| Secondary | To investigate other aspects related to tolerability | From enrolment to 4 weeks after last dose | 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. | ClinicalTrials.gov |
| Secondary | To investigate other aspects related to tolerability | From enrolment to 4 weeks after last dose | 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. | ClinicalTrials.gov |
| Secondary | To investigate other aspects related to tolerability | From enrolment to 4 weeks after last dose | 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. | ClinicalTrials.gov |
| Secondary | To investigate other aspects related to tolerability | From enrolment to 4 weeks after last dose | 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. | ClinicalTrials.gov |
| Secondary | To investigate other aspects related to tolerability | From enrolment to 4 weeks after last dose | Body weight (kg). Measured values will be presented descriptively with means per dosing cohort. Any significant intraindividual changes between study visits will be tabulated. | ClinicalTrials.gov |
| Secondary | To investigate other aspects related to tolerability | From enrollment until 4 weeks after last dose | Physical examinations: Any new findings or changes to previous findings considered to be clinically significant will be tabulated. | ClinicalTrials.gov |
| Secondary | Plasma concentration of each of the AAs in the total amino acids (tAA) | From enrollment to 4 weeks after last dose | * Area-Under-the-Curve (AUC) from baseline to each time-point * Plasma concentration fluctuations | ClinicalTrials.gov |
| Secondary | Plasma concentration of each of the AAs in the total amino acids (tAA) | From enrollment to 4 weeks after last dose | * Maximum plasma concentration (Cmax) * Plasma concentration fluctuations | ClinicalTrials.gov |
| Secondary | Evaluate palatability of the phelimin formulation | 1 hour after each administration of study intervention, from enrollment to 4 weeks after last dose | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)