T-ACE Oil by TAE/TACE in Patients With Hepatocellular Carcinoma

NCT05435014 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: TACE-OHEP-001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 4

Brief Summary

The phase I/II, double-blind, randomized study will investigate the efficacy and safety of TACE/TAE treatment with T-ACE Oil in patients with unresectable hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

TAE; TACE; Hepatocellular Carcinoma; T-ACE Oil; TACE-OHEP-001

Outcome Measures

Primary Outcomes (85)

• Phase I part: Adverse Events as Assessed by CTCAE v5.0

  All Adverse Events (AEs) occurring while on study must be documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. Pre-existing conditions will be recorded as baseline on the "Medical History" of CRF. If the pre-existing condition does not change, it does not have to be reported as an AE on subsequent cycles. However, if it deteriorates at any time during the study, it will be recorded as an AE.

  Up to 12 weeks

• Phase I part: Adverse Events of Special Interest (AESIs)

  Pulmonary embolism and cerebral embolism will be considered adverse events of special interest (AESIs). AESIs will be analyzed as a safety endpoint.

  Up to 12 weeks after treatment

• Phase I part: Incidence of all serious adverse events (SAEs) after TAE/TACE treatment with T-ACE Oil

  7 weeks after treatment

• Phase I part: Safety variables evaluation - Blood pressures

  Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Blood pressures

  Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - Blood pressures

  Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - Blood pressures

  Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - Blood pressures

  Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Blood pressures

  Blood pressures (including SBP and DBP, unit: mmHg)of subjects will be measured.

  7 weeks after treatment (V5)

• Phase I part: Safety variables evaluation - pulse rate

  Pulse rate (beats/min) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - pulse rate

  Pulse rate (beats/min) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - pulse rate

  Pulse rate (beats/min) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - pulse rate

  Pulse rate (beats/min) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - pulse rate

  Pulse rate (beats/min) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - pulse rate

  Pulse rate (beats/min) of subjects will be measured.

  7 weeks after treatment (V5)

• Phase I part: Safety variables evaluation - Body weight.

  Body weight (kilograms) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Body weight.

  Body weight (kilograms) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - Body weight.

  Body weight (kilograms) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - Body weight.

  Body weight (kilograms) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - Body weight.

  Body weight (kilograms) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Body weight.

  Body weight (kilograms) of subjects will be measured.

  7 weeks after treatment (V5)

• Phase I part: Safety variables evaluation - Respiratory rate

  Respiratory rate (times/min) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Respiratory rate

  Respiratory rate (times/min) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - Respiratory rate

  Respiratory rate (times/min) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - Respiratory rate

  Respiratory rate (times/min) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - Respiratory rate

  Respiratory rate (times/min) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Respiratory rate

  Respiratory rate (times/min) of subjects will be measured.

  7 weeks after treatment (V5)

• Phase I part: Safety variables evaluation - Body temperature.

  Body temperature (oC) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Body temperature.

  Body temperature (oC) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - Body temperature.

  Body temperature (oC) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - Body temperature.

  Body temperature (oC) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - Body temperature.

  Body temperature (oC) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Body temperature.

  Body temperature (oC) of subjects will be measured.

  7 weeks after treatment (V5)

• Phase I part: Safety variables evaluation - WBC

  WBC (1000/uL) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - WBC

  WBC (1000/uL) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - WBC

  WBC (1000/uL) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - WBC

  WBC (1000/uL) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - WBC

  WBC (1000/uL) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Platelet count

  Platelet count (1000/uL) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Platelet count

  Platelet count (1000/uL) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - Platelet count

  Platelet count (1000/uL) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - Platelet count

  Platelet count (1000/uL) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - Platelet count

  Platelet count (1000/uL) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Hb

  Hb (g/dL) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Hb

  Hb (g/dL) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - Hb

  Hb (g/dL) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - Hb

  Hb (g/dL) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - Hb

  Hb (g/dL) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - blood urea nitrogen test

  BUN (mg/dL) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - blood urea nitrogen test

  BUN (mg/dL) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - blood urea nitrogen test

  BUN (mg/dL) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - blood urea nitrogen test

  BUN (mg/dL) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - blood urea nitrogen test

  BUN (mg/dL) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Bilirubin

  Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Bilirubin

  Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - Bilirubin

  Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - Bilirubin

  Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - Bilirubin

  Bilirubin-T and Bilirubin-D (mg/dL) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Renal function

  Creatinine (mg/dL) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Renal function

  Creatinine (mg/dL) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - Renal function

  Creatinine (mg/dL) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - Renal function

  Creatinine (mg/dL) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - Renal function

  Creatinine (mg/dL) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Liver function

  AST and ALT (U/L) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Liver function

  AST and ALT (U/L) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - Liver function

  AST and ALT (U/L) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - Liver function

  AST and ALT (U/L) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - Liver function

  AST and ALT (U/L) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Coagulation function

  Prothrombin time and APTT (seconds) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Coagulation function

  Prothrombin time and APTT (seconds) of subjects will be measured.

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - Coagulation function

  Prothrombin time and APTT (seconds) of subjects will be measured.

  discharge of hospitalization (V2A)(1 to 7 days of discharge of hospitalization)

• Phase I part: Safety variables evaluation - Coagulation function

  Prothrombin time and APTT (seconds) of subjects will be measured.

  2 weeks after treatment (V3)

• Phase I part: Safety variables evaluation - Coagulation function

  Prothrombin time and APTT (seconds) of subjects will be measured.

  6 weeks after treatment (V4)

• Phase I part: Safety variables evaluation - Thyroid function (T3)

  T3 (ng/dL) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Thyroid function (T3)

  T3 (ng/dL) of subjects will be measured.

  6 weeks after treatment (V4).

• Phase I part: Safety variables evaluation - Thyroid function (Free T4)

  T4 (ng/dL) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Thyroid function (Free T4)

  T4 (ng/dL) of subjects will be measured.

  6 weeks after treatment (V4).

• Phase I part: Safety variables evaluation - Thyroid function (TSH)

  TSH (uIU/ml) of subjects will be measured.

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - Thyroid function (TSH)

  TSH (uIU/ml) of subjects will be measured.

  6 weeks after treatment (V4).

• Phase I part: Safety variables evaluation - ECG test

  Electrocardiogram (ECG) of subjects will be measured. The participants with treatment-related adverse events will be assessed by CTCAE v5.0

  Pre-intervention (V1)(-28 to -1 days)

• Phase I part: Safety variables evaluation - ECG test

  Electrocardiogram (ECG) of subjects will be measured. The participants with treatment-related adverse events will be assessed by CTCAE v5.0

  immediately after the intervention (V2)

• Phase I part: Safety variables evaluation - ECG test

  Electrocardiogram (ECG) of subjects will be measured. The participants with treatment-related adverse events will be assessed by CTCAE v5.0

  6 weeks after treatment (V4)

• Phase II part: T-ACE Oil or Lipiodol deposition type on CT scan after TAE/TACE treatment.

  CT or MRI image should be taken at the screening visit, after the TAE or TACE procedure and visit 4 (6 weeks after TAE or TACE procedure). No additional contrast will be administered for the CT after TAE or TACE procedure. V1 and V4 image evaluation will be performed by MRI. V2 image evaluation method will be performed by CT scan. If the subject has had an MRI examination within 28 days before TAE/TACE treatment, the V1 MRI can be skipped.

  72 hours after treatment

• Phase II part: mRECIST overall response at 6 weeks after TAE/TACE treatment.

  mRECIST (modified Response Evaluation Criteria in Solid Tumors) overall response and mRECIST target lesion response will be evaluated based on the image taken at the screening visit and at visit 4 (6 weeks after TAE or TACE procedure). mRECIST overall response for each patient will be categorized: Complete response (CR), Partial response (PR), Stable disease (SD), and Progressive disease (PD). mRECIST overall response is based on target lesions and non-target lesions responses and appearance of new lesions and/or extra-hepatic disease.

  6 weeks after treatment.

• Phase II part: target lesion response at 6 weeks after TAE/TACE treatment.

  target lesion response will be evaluated based on the image

  6 weeks after treatment.

Secondary Outcomes (76)

• Phase I part: T-ACE Oil deposition type on CT scan after TAE/TACE treatment with T-ACE Oil.

  72 hours after treatment

• Phase I part: mRECIST overall response at 6 weeks after TAE/TACE treatment with T-ACE Oil.

  6 weeks after treatment.

• Phase I part: target lesion response at 6 weeks after TAE/TACE treatment with T-ACE Oil.

  6 weeks after treatment.

• Phase II part: Incidence of all adverse events (AEs) after TAE/TACE treatment with T-ACE Oil or Lipiodol.

  7 weeks after treatment

• Phase II part: Incidence of adverse events of special interest (AESIs) after TAE/TACE treatment with T-ACE Oil or Lipiodol.

  7 weeks after treatment

Study Arms (2)

T-ACE Oil

EXPERIMENTAL

TAE/TACE treatment was performed with T-ACE Oil.

Drug: T-ACE Oil

Lipiodol

ACTIVE COMPARATOR

TAE/TACE treatment was performed with Lipiodol.

Drug: Lipiodol

Interventions

T-ACE Oil DRUG

TAE/TACE treatment was performed with T-ACE Oil. The volume of T-ACE Oil injected will be 1-1.5 mL/cm based on the diameter (cm) of the treated tumor, with room for adjustment per subject's condition or Investigator's judgement. The maximum dose of T-ACE Oil is 0.25 mL/kg/day but not over 15 mL for each treatment. The maximum dose of doxorubicin for a single TACE will be based on standard practice at each site with a maximum of 50 mg. Doxorubicin will be constituted according to labeling and site procedures at a concentration of 10 mg/mL. The emulsion to be injected will have a recommended v/v ratio of 2:1 to 2.5:1 (study product : saline with Doxorubicin dissolved within it). If more than the maximum dose of doxorubicin would be needed to form an emulsion with T-ACE Oil, the remaining volume administered will be study product only.

T-ACE Oil

Lipiodol DRUG

TAE/TACE treatment was performed with Lipiodol®. The volume of Lipiodol® injected will be 1-1.5 mL/cm based on the diameter (cm) of the treated tumor, with room for adjustment per subject's condition or Investigator's judgement. The maximum dose of T-ACE Oil is 0.25 mL/kg/day but not over 15 mL for each treatment. The maximum dose of doxorubicin for a single TACE will be based on standard practice at each site with a maximum of 50 mg. Doxorubicin will be constituted according to labeling and site procedures at a concentration of 10 mg/mL. The emulsion to be injected will have a recommended v/v ratio of 2:1 to 2.5:1 (study product : saline with Doxorubicin dissolved within it). If more than the maximum dose of doxorubicin would be needed to form an emulsion with Lipiodol®, the remaining volume administered will be study product only.

Also known as: Lipiodol®, Lipiodol Ultra Fluide®

Lipiodol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of over 18 years (or according to local legal definition of majority).
• Patients diagnosed of HCC (Meet at least ONE of the following criteria):
• A. Diagnosed via tumor biopsy by pathologists and confirmed by on-service physician. B. High risk patients (viral hepatitis B or C or cirrhotic) with typical liver cancer image appeared on MRI or CT scan.
• In very early stage to intermediate stage by BCLC staging (2018 AASLD), HCC tumor numbers ≦ 10, largest HCC tumor size \< 7 centimeters (determined by CT, MRI or ultrasound), with liver function at Child-Pugh score\[1\] ≦ 8.
• Disease can be treated by trans-arterial chemoembolization, and can be evaluated by Magnetic resonance imaging (MRI), or computed tomography (CT).
• Patients who only require a single TAE/TACE treatment to treat all HCC tumors at once.
• Target HCC tumors should have at least 1 tumor that is larger than 1 cm in diameter (determined by CT, MRI or ultrasound). Subjects who have experienced on Lipiodol®-based TAE or TACE treatments are fine to recruit.
• May have received local therapy such as TAE, TACE, radiofrequency ablation (RFA) or surgery and remain eligible for study provided the prior therapy was within the following timeframes and the subject has fully recovered from prior therapy: A. TAE/TACE: more than 8 weeks since completion of prior therapy B. RFA: After PI confirm subject is fully recovered from prior therapy based on screening visit physical examination and liver function laboratory tests results. C. Surgery: After PI confirm subject is fully recovered from prior therapy based on screening visit physical examination and liver function laboratory tests results.
• Patients able to understand, willing to accept and cooperate with all clinical trial practices.
• Willing to sign a written informed consent form.

You may not qualify if:

• Major branch of portal vein has been invaded by HCC, or the patient has extrahepatic metastasis or other current malignant tumors.
• Eligible for curative surgery or transplant as judged by PI.
• Evidences of decompensation (Meet at least ONE of the following criteria):
• Total Bilirubin \> 2 mg/dL
• INR \> 1.7
• Child-Pugh score \>8
• refractory ascites
• active bleeding
• hepatic encephalopathy
• severe infection
• Any of the following findings (but not limit to):
• Heart failure (NYHA Class III or IV), COPD (Stage III or IV)
• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>500 milliseconds (ms) (CTCAE grade 3) using Fridericia's QT correction formula.
• A history of risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or use of concomitant medications that prolong the QT/QTc interval (e.g., class Ia, Ic or III antiarrhythmic drugs, tricyclic antidepressants or phenothiazines)
• Bronchial asthma that may increase the risk associated with study participation, or may interfere with compliance of the protocol as judged by the PI.

Sponsors & Collaborators

• T-ACE Medical Co., Ltd: lead

Study Sites (4)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Tungs' Taichung Metroharbor Hospital

Taichung, 435, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 701, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (4)

• Miyayama S, Yamashiro M, Okuda M, Yoshie Y, Sugimori N, Igarashi S, Nakashima Y, Notsumata K, Toya D, Tanaka N, Mitsui T, Matsui O. Chemoembolization for the treatment of large hepatocellular carcinoma. J Vasc Interv Radiol. 2010 Aug;21(8):1226-34. doi: 10.1016/j.jvir.2010.04.015. Epub 2010 Jul 3.

  PMID: 20598571 BACKGROUND

• Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.

  PMID: 20175033 BACKGROUND

• Lencioni R, de Baere T, Soulen MC, Rilling WS, Geschwind JF. Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data. Hepatology. 2016 Jul;64(1):106-16. doi: 10.1002/hep.28453. Epub 2016 Mar 7.

  PMID: 26765068 BACKGROUND

• Wang Z, Lin M, Lesage D, Chen R, Chapiro J, Gu T, Tacher V, Duran R, Geschwind JF. Three-dimensional evaluation of lipiodol retention in HCC after chemoembolization: a quantitative comparison between CBCT and MDCT. Acad Radiol. 2014 Mar;21(3):393-9. doi: 10.1016/j.acra.2013.11.006.

  PMID: 24507426 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Ethiodized Oil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Po-Chin Liang, PhD, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Xi-Zhang Lin, MD

  T-ACE Medical Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I/II, interventional study; competitive enrollment, multi study center * Phase I part: Open label, single arm, sequential enrollment * Phase II part: Randomized, double-blind, active controlled

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: June 28, 2022
• Study Start: September 13, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

TW (4)