Healthy VolunteersPhase 1NCT06726863

Pharmacokinetics and Pharmacodynamics of Two Prolonged-release Formulations of Vamifeport in Healthy Adults

A Phase 1 study testing Vamifeport IRF, Vamifeport PR1 and Vamifeport PR2 in people with Healthy Volunteers, run by CSL Behring at 1 site in United Kingdom.

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, single-center, randomized, open-label study to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of vamifeport after multiple oral administrations of one immediate-release (IR) formulation and after single and multiple oral administrations of two prolonged-release (PR)… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Vamifeport IRF, Vamifeport PR1 and Vamifeport PR2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited Kingdom
Study dates: 22 Nov 2024to 1 Feb 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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged greater than or equal to (>=) 18 to less than or equal to (<=) 60 years when providing written informed consent.
Healthy, as determined by the investigator based on review of defined assessments during Screening.
Body weight between 50 and 100 kilograms (kg) (inclusive) and body mass index within the range 18.0 to 32.0 kg per meter squared (kg/m2) (inclusive) at Screening and Day -1.

Who cannot join

Any clinically relevant abnormal 12-lead ECG finding at Screening or Day -1 (as deemed by the investigator).
Serum ferritin of < 30 nanograms per milliliter (ng/mL) or > 300 ng/mL for assigned male at birth (AMAB) subjects or <16 ng/mL or > 300 ng/mL for assigned female at birth (AFAB) subjects at Screening or Day -1.
Hemoglobin < 13 grams per deciliter (g/dL) (8.1 millimoles per liter [mmol/L]) for AMAB subjects or 12 g/dL (7.5 mmol/L) for AFAB subjects at Screening or Day -1.
Blood draw or donation of blood (>= 450 mL) within 3 months before Screening, plasma from 2 weeks before Screening, or platelets from 6 weeks before Screening.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Investigator Site 82600083
Leeds, West Yorkshire, LS11

Other trials in United Kingdom

About this study

Official title: A Phase 1, Randomized, Open-label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Vamifeport After Multiple Oral Administration of One Immediate-release Formulation and After Single and Multiple Oral Administration of Two Prolonged-release Formulations in Healthy Adult Subjects

Conditions: Healthy Volunteers
Being tested: Vamifeport IRF, Vamifeport PR1, Vamifeport PR2
Keywords: Oral ferroportin inhibitor, Ferroportin transporter, Iron overload, Iron metabolism
Medical subject headings: Iron Overload

What participants receive

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

Vamifeport IRFDrug
Also called CSL624
Vamifeport IRF will be administered orally as per the dosing levels and formulations for respective treatment periods.
Vamifeport PR1Drug
Also called CSL624
Vamifeport PR1 will be administered orally as per the dosing levels and formulations for respective treatment periods.
Vamifeport PR2Drug
Also called CSL624
Vamifeport PR2 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Study groups in NCT06726863
Study group	Role	What they receive
Treatment Period 1: Vamifeport IR Formulation Dose Level 1	Experimental	Participants will receive multiple doses of Vamifeport Immediate-release (IR) formulation at Dose level 1. Receives: Drug: Vamifeport IRF
Treatment Period 2: Vamifeport PR1 Dose Level 2	Experimental	Participants will receive multiple doses of Vamifeport Prolonged-release formulation 1 (PR1) at Dose level 2. Receives: Drug: Vamifeport PR1
Treatment Period 2: Vamifeport PR2 Dose Level 2	Experimental	Participants will receive multiple doses of Vamifeport Prolonged-release formulation 2 (PR2) at Dose level 2. Receives: Drug: Vamifeport PR2
Treatment Period 3: Vamifeport PR1 Dose Level 3	Experimental	Participants will receive a single dose of Vamifeport PR1 at Dose level 3. Receives: Drug: Vamifeport PR1
Treatment Period 3: Vamifeport PR2 Dose Level 3	Experimental	Participants will receive a single dose of Vamifeport PR2 at Dose level 3. Receives: Drug: Vamifeport PR2
Treatment Period 4: Vamifeport PR1 Dose Level 3	Experimental	Participants will receive a single dose of Vamifeport PR1 at Dose level 3. Receives: Drug: Vamifeport PR1
Treatment Period 4: Vamifeport PR2 Dose Level 3	Experimental	Participants will receive a single dose of Vamifeport PR2 at Dose level 3. Receives: Drug: Vamifeport PR2

What is being measured

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

Plasma concentration-time course profiles of vamifeport
Measured: Treatment Period (TP) 2: Before and after dosing on Day 4 (up to 12 hours), Day 8 (up to 48 hours), Before dosing on Day 5, 6, 7 TP 3: Before and after dosing on Day 13 (up to 48 hours) TP 4: Before and after dosing on Day 16 (up to 48 hours)
Maximum plasma concentration (Cmax) of first and last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP2: Before, and up to 48 hours after, both the first and the last dose
Time to reach Cmax (Tmax) of first and last dose vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 48 hours after, both the first and the last dose
Area under the plasma concentration curve from time zero to 12 hours (AUC0-12) of first and last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 48 hours after, both the first and the last dose
Trough concentration (Ctrough) of first dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: Before and up to 24 hours after the first dose in TP2
AUC from time zero to infinity (AUC0-inf) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 48 hours after last dose
AUC from time zero to time tlast (AUC0-last) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 48 hours after last dose
AUC from time zero to 8 hours (AUC0-8) and 24 hours (AUC0-24) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 8 and 24 hours after last dose
Plasma concentration at 12 hours (Conc [t=12]) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before and up to 12 hours after last dose
Apparent clearance (CL/F) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 48 hours after last dose
Apparent volume of distribution at steady state (Vss/F) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 48 hours after last dose
Accumulation ratio (Rac) of Cmax between first and last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 48 hours after first and last dose
Rac(Ctrough/Conc[t=12]) between first and last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 12 hours after first and last dose
Rac (AUC0-12) between first and last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 12 hours after first and last dose
Half-life (t1/2) after last dose of vamifeport PR1 and PR2 in Treatment Period 2
Measured: TP 2: Before, and up to 48 hours after last dose
Cmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Measured: Before and up to 48 hours after dosing, in TP3 and TP4
Tmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Measured: Before and up to 48 hours after dosing, in TP3 and TP4
AUC0-inf of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Measured: Before and up to 48 hours after dosing, in TP3 and TP4
AUC0-last of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Measured: Before and up to 48 hours after dosing, in TP3 and TP4
AUC0-8, AUC0-12 and AUC0-24 of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Measured: Before and up to 8, 12 and 24 hours after dosing, in TP3 and TP4
Plasma Concentration at 8 hours (Conc [t=8]), 12 hours (Conc [t=12]) and 24 hours (Conc [t=24]) of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Measured: Before and up to 8, 12 and 24 hours after dosing, in TP3 and TP4
CL/F of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Measured: Before and up to 48 hours after dosing, in TP3 and TP4
t1/2 of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Measured: Before and up to 48 hours after dosing, in TP3 and TP4
Apparent volume of distribution (Vz/F) of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Measured: Before and up to 48 hours after dosing, in TP3 and TP4

Secondary outcomes (22)

Number of participants with treatment-emergent (TE): adverse event (AE), AE by severity, AE related to vamifeport, and serious AE
Measured: Up to 25 days after treatment
Percentage of participants with TEAE, AE by severity, AE related to vamifeport, and serious AE
Measured: Up to 25 days after treatment
Number of participants with clinically significant change from Baseline in clinical laboratory safety tests, 12 lead Electrocardiogram (ECG), and vital signs
The clinical laboratory safety tests include biochemistry, hematology, urinalysis.
Measured: At baseline and up to 25 days after treatment
AUC0-24 of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of AUC0-24 between PR1 and PR2
Measured: Before and up to 24 hours after dosing, in TP3 and TP4
AUC0-12 of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of AUC0-12 between PR1 and PR2
Measured: Before and up to 12 hours after dosing, in TP3 and TP4
AUC0-inf of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of AUC0-inf between PR1 and PR2
Measured: Before and up to 48 hours after dosing, in TP3 and TP4
Conc (t=12) of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of conc(t=12) between PR1 and PR2
Measured: Before and up to 12 hours after dosing, in TP3 and TP4
Conc (t=24) of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of conc(t=24) between PR1 and PR2
Measured: Before and up to 24 hours after dosing, in TP3 and TP4
Cmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of cmax between PR1 and PR2
Measured: Before and up to 48 hours after dosing, in TP3 and TP4
Tmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of tmax between PR1 and PR2
Measured: Before and up to 48 hours after dosing, in TP3 and TP4
Absolute values of serum iron
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Absolute values of transferrin saturation (TSAT)
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Change from baseline of serum iron
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Change from baseline of TSAT
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Maximum percentage change from baseline (Emax) of serum iron
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Emax of TSAT
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Time to Emax (TEmax) of serum iron
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
TEmax of TSAT
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Time below baseline of serum iron
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Time below baseline of TSAT
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
AUC below baseline of serum iron
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4
AUC below baseline of TSAT
Measured: Before and up to 48 hours after dosing in TP2, TP3 and TP4

Timeline

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

22 Nov 20241 Feb 2025

First posted10 Dec 2024
Study start22 Nov 2024
Primary completion27 Jan 2025
Study completion1 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by CSL BehringThe 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: Sequential
Model description: This is a 4-treatment period study that uses three different models: Treatment Period 1 will be a single-arm model, Treatment Period 2 will be a parallel-group model, and Treatment Periods 3 and 4 will be crossover models.
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06726863
Sponsor's protocol ID: CSL624_1005
Status last verified: Jun 2025
First submitted: 6 Dec 2024
Last updated: 27 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

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?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Vamifeport After Multiple Oral Administration of One Immediate-release Formulation and After Single and Multiple Oral Administration of Two Prolonged-release Formulations in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT06726863
Acronym / sponsor ID: CSL624_1005
Conditions: Healthy Volunteers
Keywords: Oral ferroportin inhibitor, Ferroportin transporter, Iron overload, Iron metabolism
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: CSL BehringIndustry (pharma, biotech, devices)
Study start: 22 Nov 2024 (actual)
Primary completion: 27 Jan 2025 (actual)
Study completion: 1 Feb 2025 (actual)
First posted: 10 Dec 2024 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7
Model description: This is a 4-treatment period study that uses three different models: Treatment Period 1 will be a single-arm model, Treatment Period 2 will be a parallel-group model, and Treatment Periods 3 and 4 will be crossover models.

Arm	Type	Receives
Treatment Period 1: Vamifeport IR Formulation Dose Level 1	Experimental	Drug: Vamifeport IRFParticipants will receive multiple doses of Vamifeport Immediate-release (IR) formulation at Dose level 1.
Treatment Period 2: Vamifeport PR1 Dose Level 2	Experimental	Drug: Vamifeport PR1Participants will receive multiple doses of Vamifeport Prolonged-release formulation 1 (PR1) at Dose level 2.
Treatment Period 2: Vamifeport PR2 Dose Level 2	Experimental	Drug: Vamifeport PR2Participants will receive multiple doses of Vamifeport Prolonged-release formulation 2 (PR2) at Dose level 2.
Treatment Period 3: Vamifeport PR1 Dose Level 3	Experimental	Drug: Vamifeport PR1Participants will receive a single dose of Vamifeport PR1 at Dose level 3.
Treatment Period 3: Vamifeport PR2 Dose Level 3	Experimental	Drug: Vamifeport PR2Participants will receive a single dose of Vamifeport PR2 at Dose level 3.
Treatment Period 4: Vamifeport PR1 Dose Level 3	Experimental	Drug: Vamifeport PR1Participants will receive a single dose of Vamifeport PR1 at Dose level 3.
Treatment Period 4: Vamifeport PR2 Dose Level 3	Experimental	Drug: Vamifeport PR2Participants will receive a single dose of Vamifeport PR2 at Dose level 3.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Aged greater than or equal to (>=) 18 to less than or equal to (<=) 60 years when providing written informed consent.
Healthy, as determined by the investigator based on review of defined assessments during Screening.
Body weight between 50 and 100 kilograms (kg) (inclusive) and body mass index within the range 18.0 to 32.0 kg per meter squared (kg/m2) (inclusive) at Screening and Day -1.

Key exclusion criteria (4 listed)

Any clinically relevant abnormal 12-lead ECG finding at Screening or Day -1 (as deemed by the investigator).
Serum ferritin of < 30 nanograms per milliliter (ng/mL) or > 300 ng/mL for assigned male at birth (AMAB) subjects or <16 ng/mL or > 300 ng/mL for assigned female at birth (AFAB) subjects at Screening or Day -1.
Hemoglobin < 13 grams per deciliter (g/dL) (8.1 millimoles per liter [mmol/L]) for AMAB subjects or 12 g/dL (7.5 mmol/L) for AFAB subjects at Screening or Day -1.
Blood draw or donation of blood (>= 450 mL) within 3 months before Screening, plasma from 2 weeks before Screening, or platelets from 6 weeks before Screening.

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
Vamifeport IRFAlso: CSL624Vamifeport IRF will be administered orally as per the dosing levels and formulations for respective treatment periods.	Drug	Treatment Period 1: Vamifeport IR Formulation Dose Level 1
Vamifeport PR1Also: CSL624Vamifeport PR1 will be administered orally as per the dosing levels and formulations for respective treatment periods.	Drug	Treatment Period 2: Vamifeport PR1 Dose Level 2, Treatment Period 3: Vamifeport PR1 Dose Level 3, Treatment Period 4: Vamifeport PR1 Dose Level 3
Vamifeport PR2Also: CSL624Vamifeport PR2 will be administered orally as per the dosing levels and formulations for respective treatment periods.	Drug	Treatment Period 2: Vamifeport PR2 Dose Level 2, Treatment Period 3: Vamifeport PR2 Dose Level 3, Treatment Period 4: Vamifeport PR2 Dose Level 3

Primary outcome

Plasma concentration-time course profiles of vamifeport
Time frame: Treatment Period (TP) 2: Before and after dosing on Day 4 (up to 12 hours), Day 8 (up to 48 hours), Before dosing on Day 5, 6, 7 TP 3: Before and after dosing on Day 13 (up to 48 hours) TP 4: Before and after dosing on Day 16 (up to 48 hours)
Maximum plasma concentration (Cmax) of first and last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP2: Before, and up to 48 hours after, both the first and the last dose
Time to reach Cmax (Tmax) of first and last dose vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 48 hours after, both the first and the last dose
Area under the plasma concentration curve from time zero to 12 hours (AUC0-12) of first and last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 48 hours after, both the first and the last dose
Trough concentration (Ctrough) of first dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: Before and up to 24 hours after the first dose in TP2
AUC from time zero to infinity (AUC0-inf) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 48 hours after last dose
AUC from time zero to time tlast (AUC0-last) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 48 hours after last dose
AUC from time zero to 8 hours (AUC0-8) and 24 hours (AUC0-24) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 8 and 24 hours after last dose
Plasma concentration at 12 hours (Conc [t=12]) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before and up to 12 hours after last dose
Apparent clearance (CL/F) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 48 hours after last dose
Apparent volume of distribution at steady state (Vss/F) of last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 48 hours after last dose
Accumulation ratio (Rac) of Cmax between first and last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 48 hours after first and last dose
Rac(Ctrough/Conc[t=12]) between first and last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 12 hours after first and last dose
Rac (AUC0-12) between first and last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 12 hours after first and last dose
Half-life (t1/2) after last dose of vamifeport PR1 and PR2 in Treatment Period 2
Time frame: TP 2: Before, and up to 48 hours after last dose
Cmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
Tmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
AUC0-inf of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
AUC0-last of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
AUC0-8, AUC0-12 and AUC0-24 of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 8, 12 and 24 hours after dosing, in TP3 and TP4
Plasma Concentration at 8 hours (Conc [t=8]), 12 hours (Conc [t=12]) and 24 hours (Conc [t=24]) of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 8, 12 and 24 hours after dosing, in TP3 and TP4
CL/F of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
t1/2 of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
Apparent volume of distribution (Vz/F) of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

22 secondary outcomes

Number of participants with treatment-emergent (TE): adverse event (AE), AE by severity, AE related to vamifeport, and serious AE
Time frame: Up to 25 days after treatment
Percentage of participants with TEAE, AE by severity, AE related to vamifeport, and serious AE
Time frame: Up to 25 days after treatment
Number of participants with clinically significant change from Baseline in clinical laboratory safety tests, 12 lead Electrocardiogram (ECG), and vital signs
Time frame: At baseline and up to 25 days after treatment
AUC0-24 of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 24 hours after dosing, in TP3 and TP4
AUC0-12 of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 12 hours after dosing, in TP3 and TP4
AUC0-inf of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
Conc (t=12) of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 12 hours after dosing, in TP3 and TP4
Conc (t=24) of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 24 hours after dosing, in TP3 and TP4
Cmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
Tmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
Absolute values of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Absolute values of transferrin saturation (TSAT)
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Change from baseline of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Change from baseline of TSAT
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Maximum percentage change from baseline (Emax) of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Emax of TSAT
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Time to Emax (TEmax) of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
TEmax of TSAT
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Time below baseline of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Time below baseline of TSAT
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
AUC below baseline of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
AUC below baseline of TSAT
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
Individual participant dataSharing planned: Yes. CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

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Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

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.

Study Director study director

CSL Behring

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 Vamifeport IRF, Vamifeport PR1 and Vamifeport PR2 in people with Healthy Volunteers, run by CSL Behring at 1 site in United Kingdom.

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 4 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 27 Jun 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 United Kingdom. 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?

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?

Plasma concentration-time course profiles of vamifeport (time frame: Treatment Period (TP) 2: Before and after dosing on Day 4 (up to 12 hours), Day 8 (up to 48 hours), Before dosing on Day 5, 6, 7 TP 3: Before and after dosing on Day 13 (up to 48 hours) TP 4: Before and after dosing on Day 16 (up to 48 hours)). The study lists 24 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 NCT06726863.

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 27 Jun 2025.