Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPharmaIN
About this trial
This 2-part study will evaluate PHIN-214 given as a single one-time dose (Part 1) and in multiple doses (given as daily doses for 28-days) (in Part 2). Specifically, this study evaluates PHIN-214, to determine the safety, tolerability, and pharmacokinetic effects of PHIN-214, and to establish the maximum tolerated dose or optimal beneficial dose in patients with Child Pugh A and B Cirrhosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B
Participants may be male or female aged 18 to 75 years.
Body mass index (BMI) within the range 18 to 40 kg/m2 (inclusive) at screening.
Female participants must be non-pregnant, non-lactating, or of non-childbearing potential or using highly efficient contraception for the full duration of the study
Disqualifiers
Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities.
History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
Significant kidney disease
Hepatic encephalopathy (HE) or altered mental status requiring hospitalization; variceal bleeding or upper gastrointestinal bleeding; or type 1 hepatorenal syndrome with acute kidney injury (HRS-AKI) during the previous 3 months prior to Screening.
Trial design
Design model
Sequential
Treatments tested in this trial
PHIN-214 Subcutaneous injection
Drugsubcutaneous injection(s) with PHIN-214 terlipressin derivative
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: single dose of PHIN-214Experimental treatment 1 intervention
Group B: multiple daily dosing of PHIN-214Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability.
Incidence of adverse effects (type and severity), incidence of dose limiting toxicities, changes in key laboratory measures
Time frame
may be up to six weeks2
Pharmacokinetics of PHIN-214
plasma concentration of PHIN-214
Time frame
up to six weeks3
Pharmacokinetics of PHIN-214 metabolite
plasma concentration of PHIN-214 metabolite
Time frame
up to six weeksSecondary outcomes
1
Immunogenicity of PHIN-214
anti-drug antibody testing
Time frame
up to six weeksOther outcomes
1
Blood pressure
Blood pressure (vital signs)
Time frame
up to six weeks2
Heart rate
Heart rate (vital signs)
Time frame
up to six weeks3
12-lead ECG
12-lead ECG
Time frame
up to six weeks4
Oxygenation level
Oxygenation level by pulse oximeter
Time frame
up to six weeks Source ClinicalTrials.gov