TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT06594445
Drug: GTB-360
Normalized name: GTB-3550
DrugBank: GTB-3550 (DB18494)
Approvals — FDA: no, EMA: no, PMDA: no
Description: GTB-3650 is administered by a continuous infusion (CI). A patient's dose of GTB-3650 is calculated using their assigned Dose Level and their actual body weight (ABW) obtained within 5 days prior to or on Cycle 1, Day 1.~Dose Level 1: 1.25 ug/kg/day Dose Level 2: 2.5 ug/kg/day Dose Level 3: 5 ug/kg/day Dose Level 4: 10 ug/kg/day Dose Level 5: 25 ug/kg/day Dose Level 6: 50 ug/kg/day Dose Level 7: 100 ug/kg/day
Study: NCT06657924
Drug: Tranexamic acid
Normalized name: Tranexamic Acid
DrugBank: Tranexamic acid (DB00302)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 1 gram IV bolus in 100ml of normal saline administered over 10 minutes at the start and end of the surgery for a total of 2 grams TXA
Study: NCT06663319
Drug: JNJ-89402638
Normalized name: JNJ-42847922
DrugBank: Seltorexant (DB14961)
Approvals — FDA: no, EMA: no, PMDA: no
Description: JNJ-89402638 will be administered.
Study: NCT06602466
Drug: Colgate Cavity Protection Toothpaste
Normalized name: Colgate
DrugBank: Sodium fluoride (DB09325)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Commercial toothpaste containing 1450 ppm fluoride.
Study: NCT06594991
Drug: Fianlimab
Normalized name: Fianlimab
DrugBank: Fianlimab (DB18858)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Fianlimab IV given every three weeks
Study: NCT06594991
Drug: Cemiplimab
Normalized name: CEMIPLIMAB
DrugBank: Cemiplimab (DB14707)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Cemiplimab IV given every three weeks
Study: NCT06594991
Drug: Ipilimumab
Normalized name: Ipilimumab
DrugBank: Ipilimumab (DB06186)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Ipilimumab will be give every 6 weeks continuously
Study: NCT05883956
Drug: Subcutaneous azacitidine
Normalized name: Azacitidine
DrugBank: Azacitidine (DB00928)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Subcutaneous azacitidine, 75mg/m2, 7 days
Study: NCT06403150
Drug: Levetiracetam Injection
Normalized name: levetiracetam Injection
DrugBank: Levetiracetam (DB01202)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: Levetiracetam at 60 mg/kg (max dose 4500 mg) will be intravenously administered in 100mL of normal saline at an administration rate of 2-5mg/kg/min or over 10 minutes. After 30 minutes following Levetiracetam needle time reassessment of the patient will be done to determine the outcomes.
Study: NCT06036589
Drug: CA
Normalized name: CAZ
DrugBank: Ceftazidime (DB00438)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: CA (tran-cinnamaldheyde) solution (in ethanol 5%) application to a previously determined area on the volar forearm
Study: NCT06589726
Drug: Moxifloxacin
Normalized name: Moxifloxacin
DrugBank: Moxifloxacin (DB00218)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in either of treatment period 1, 2, 3 and 4.
Study: NCT06589726
Drug: Enpatoran low dose
Normalized name: ethinyl estradiol
DrugBank: Enpatoran (DB16501)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in either of treatment period 1, 2, 3 and 4.
Study: NCT06589726
Drug: Enpatoran high dose
Normalized name: high-density polyethylene
DrugBank: Enpatoran (DB16501)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in either of treatment period 1, 2, 3 and 4.
Study: NCT06118320
Drug: Potassium sodium hydrogen citrate
Normalized name: sodium hydrogen sulfite
DrugBank: Potassium sodium hydrogen citrate (DB16585)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Medication: Potassium sodium hydrogen citrate granules (MADAUS GMBH, Germany, 2.5g/package).~Method: Preprandial urine pH was monitored to maintain an effective range of 6.2 to 6.8. One package should be taken after breakfast, one after lunch, and two after dinner. If the pH falls below 6.2, a half-package dose should be added; if it exceeds 6.8, a half-package dose should be reduced accordingly. Oral medication will be administered for a duration of three months.~Medication requirements: Abstain from alcohol and smoking during treatment period and avoid using any probiotics or drugs that lower uric acid levels.
Study: NCT05263505
Drug: Baricitinib 2 MG [Olumiant]
Normalized name: baricitinib 2 MG [Olumiant]
DrugBank: Baricitinib (DB11817)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Two tabs daily
Study: NCT05263505
Drug: Mycophenolate
Normalized name: mycophenolate
DrugBank: Mycophenolic acid (DB01024)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Target Dose: 1g twice daily
Study: NCT05692154
Drug: Fexofenadine
Normalized name: Fexofenadine
DrugBank: Fexofenadine (DB00950)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Fexofenadine oral tablet
Study: NCT06337331
Drug: Venetoclax
Normalized name: Venetoclax
DrugBank: Venetoclax (DB11581)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 400mg/day PO Days -8 to -2
Study: NCT06337331
Drug: Decitabine
Normalized name: Decitabine
DrugBank: Decitabine (DB01262)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 20mg/m2/day IV Days -7 to -3
Study: NCT06103760
Drug: Esketamine Nasal Spray [Spravato]
Normalized name: esketamine Nasal Spray [Spravato]
DrugBank: Ketamine (DB01221)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: This is an uncontrolled, single arm, naturalistic study. There will be three treatment phases: Phase 1 - Acute treatment phase (weeks 1-4); Phase 2 - Maintenance treatment phase (weeks 5-8); Phase 3 - Continuation treatment phase (Weeks 9-25). Phase 1 is the critical component of our study as it determines our primary outcomes.
Study: NCT06337331
Drug: Fludarabine
Normalized name: Fludarabine
DrugBank: Fludarabine (DB01073)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 30mg/m2/day IV Days -7 to -3
Study: NCT06337331
Drug: Busulfan
Normalized name: Busulfan
DrugBank: Busulfan (DB01008)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: 3.2mg/kg/day IV Days -5 to -4
Study: NCT05586724
Drug: Micronized progesterone in continuous combination with oral estrogen
DrugBank: Progesterone (DB00396)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capsule 100 mg mP (Utrogestan®) orally per day in continuous combination with 1 mg encapsulated estradiol (Estrofem®)
Study: NCT05586724
Drug: Norethisterone acetate in continuous combination with oral estrogen
Normalized name: estrogens, conjugated (USP) / medroxyprogesterone acetate Oral Tablet
DrugBank: Norethisterone (DB00717)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Capsule 0.5 mg NETA/ 1 mg estradiol (Activelle®) orally per day (encapsulated and identical to Estrofem® and one matched placebo to Utrogestan
Study: NCT05654753
Drug: active FMT
Normalized name: Activated Charcoal
DrugBank: Activated charcoal (DB09278)
Approvals — FDA: no, EMA: no, PMDA: no
Description: MaaT033®, a lyophilized full-ecosystem intestinal microbiota delayed release oral capsule containing native, donor-derived (pooled from 4-6 donors) microbiome product manufactured by MaaT Pharma® will be delivered orally. Patients will receive 20 Maat033 capsules, each containing approximatively 0.42 g of microbiome product at once at day 0, then 3 capsules/day from day 1 through day 20.
Study: NCT04182360
Drug: Carbetocin
Normalized name: Carbetocin
DrugBank: Carbetocin (DB01282)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Carbetocin administered intravenously, over 1 minute following delivery of the fetal head.
Study: NCT06037434
Drug: Captopril Tablets
Normalized name: Captopril Tablets
DrugBank: Captopril (DB01197)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 0.3mg/kg, tid
Study: NCT06037434
Drug: Metoprolol Oral Tablet
Normalized name: metoprolol Oral Tablet
DrugBank: Metoprolol (DB00264)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 0.2mg/kg, bid
Study: NCT06037434
Drug: Torsemide Tablets
Normalized name: Torsemide Tablets
DrugBank: Torasemide (DB00214)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 0.2-0.5mg/mg, bid
Study: NCT06037434
Drug: Potassium citrate powder
Normalized name: citric acid / potassium citrate Powder for Oral Solution
DrugBank: Potassium citrate (DB09125)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: 0.06g/kg, tid
Study: NCT03757897
Drug: Dexmedetomidine
Normalized name: Dexmedetomidine
DrugBank: Dexmedetomidine (DB00633)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: The standard dosing of 1mcg/kg will be implemented over 10 minutes followed by a maintenance infusion of 0.2-1.0 titrated to a the target BIS (60-70) during the 20 minutes prior to MRI.
Study: NCT05160220
Drug: Psilocybin
Normalized name: Psilocybin
DrugBank: Psilocybin (DB11664)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 0.5 g dried Psilocybe cubensis mushroom material, 0.8 mg psilocybin.
Study: NCT05629325
Drug: Buspirone Hydrochloride 10 MG
Normalized name: buspirone hydrochloride 10 MG
DrugBank: Buspirone (DB00490)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 4 weeks of treatment with buspirone
Study: NCT05141305
Drug: tenecteplase (0.25 mg/kg, Max 25 mg)
Normalized name: Tenecteplase
DrugBank: Tenecteplase (DB00031)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: tenecteplase (0.25 mg/kg) is being used.
Study: NCT03281681
Drug: VAL-083, Dianhydrogalactitol
DrugBank: Dianhydrogalactitol (DB12873)
Approvals — FDA: no, EMA: no, PMDA: no
Description: VAL-083 given by intravenous infusion with a starting dose of 60 mg/m2 once weekly. If this regimen is well tolerated for at least three sequential weekly treatments the patient's dose may be escalated to 67 mg/m2 i.v. If the 67 mg/m2 dose is well tolerated for at least three sequential weekly treatments the patient's dose may be escalated to 75 mg/m2 i.v. once weekly for the remainder of the study. Dosing will be conducted once per week for a total of 16 weeks.
Study: NCT05200364
Drug: STRO-002
Normalized name: STRO-001
DrugBank: STRO-001 (DB17224)
Approvals — FDA: no, EMA: no, PMDA: no
Description: intravenous antibody drug conjugate
Study: NCT05200364
Drug: Bevacizumab
Normalized name: Bevacizumab
DrugBank: Bevacizumab (DB00112)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: anti-VEGF agent
Study: NCT04903652
Drug: Pyrotinib Maleate
Normalized name: maleate
DrugBank: Pyrotinib (DB14993)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Pyrotinib p.o. 400 mg once daily
Study: NCT04903652
Drug: Vinorelbine
Normalized name: Vinorelbine
DrugBank: Vinorelbine (DB00361)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Vinorelbine p.o. 40 mg once every other day
Study: NCT05967156
Drug: Empagliflozin10Mg Tab
Normalized name: Empagliflozin Tablets
DrugBank: Empagliflozin (DB09038)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: 10 mg daily
Study: NCT04959032
Drug: Lumateperone 42 mg
Normalized name: lumateperone 42 MG
DrugBank: Lumateperone (DB06077)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Lumateperone 42 mg capsules administered orally, once daily.
Study: NCT06768580
Drug: Lidocaine
Normalized name: Lidocaine
DrugBank: Lidocaine (DB00281)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Patients will receive a bolus (10 ml) of intravenous lidocaine (1mg/kg) diluted with saline over 10 min before induction of anesthesia. Continuous infusion of 1.5 mg/kg/hr of intravenous lidocaine diluted with saline (20 ml/hr) will be administered until the end of the surgery, also will receive placebo capsule the night before surgery at 9 pm, the night of operation and two nights after the surgical operation at 9 pm.
Study: NCT06769568
Drug: reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia
Normalized name: human cord blood hematopoietic progenitor cell
DrugBank: Human cord blood hematopoietic progenitor cell (DB11054)
Approvals — FDA: no, EMA: no, PMDA: no
Description: reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia
Study: NCT06768944
Drug: Psilocybin 25 mg
Normalized name: Psilocybin
DrugBank: Psilocybin (DB11664)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the high-dose (25mg)
Study: NCT06768944
Drug: Psilocybin 1 mg
Normalized name: Psilocybin
DrugBank: Psilocybin (DB11664)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the low-dose (1mg)
Study: NCT06768944
Drug: Metyrapone 750 mg
Normalized name: Metyrapone
DrugBank: Metyrapone (DB01011)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: metyrapone 750mg capsules, which will be administered in 2 doses
Study: NCT05614115
Drug: Empagliflozin
Normalized name: Empagliflozin
DrugBank: Empagliflozin (DB09038)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: is a sodium-glucose co-transporter 2 (SGLT2) inhibitor.
Study: NCT04356664
Drug: GnRH agonist
Normalized name: GnRH
DrugBank: Gonadorelin (DB00644)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: One or two intramuscular injections of Decapeptyl 3 mg
Study: NCT05036005
Drug: Ontruzant
Normalized name: Ontruzant
DrugBank: Trastuzumab (DB00072)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Addition of pertuzumab is at the discretion of investigator's decision.
Study: NCT06064344
Drug: Rituximab
Normalized name: Rituximab
DrugBank: Rituximab (DB00073)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Intralesional Rituximab Injection
Study: NCT05036005
Drug: Pertuzumab
Normalized name: Pertuzumab
DrugBank: Pertuzumab (DB06366)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Addition of pertuzumab is at the discretion of investigator's decision.
Study: NCT04833205
Drug: Nimotuzumab
Normalized name: nimotuzumab
DrugBank: Nimotuzumab (DB06192)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Nimotuzumab 200 mg was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping, the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks
Study: NCT06547476
Drug: Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib
DrugBank: Tucidinostat (DB06334)
Approvals — FDA: no, EMA: no, PMDA: yes
Description: Tucidinostat (chidamide)，30mg, po., biw PD-1 inhibitor (tislelizumab), 200mg, ivgtt. d1, q3w anlotinib, 12mg, po., d1-14, q3w
Study: NCT06248645
Drug: Oxygen
Normalized name: Oxygen
DrugBank: Oxygen (DB09140)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: High-flow oxygen (12 L/min) administered with a non-rebreathing facial mask, started as soon as possible after the beginning of the attack and for 15 minutes.
Study: NCT06014944
Drug: Short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody
Normalized name: Anti-PD-1 monoclonal antibody MGA012
DrugBank: Retifanlimab (DB15766)
Approvals — FDA: no, EMA: no, PMDA: no
Description: neoadjuvant therapy for short-course radiotherapy combined with furoquintinib and PD-1 monoclonal antibody for PMMR / MSS type middle and low locally advanced rectal cancer.
Study: NCT06152978
Drug: Sintilimab
Normalized name: Sintilimab
DrugBank: Sintilimab (DB15765)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for 2-3 cycles.
Study: NCT00031057
Drug: Riboflavin
Normalized name: Riboflavin
DrugBank: Riboflavin (DB00140)
Approvals — FDA: yes, EMA: no, PMDA: no
Study: NCT06074757
Drug: Fulvestrant injection
Normalized name: Fulvestrant Injection
DrugBank: Fulvestrant (DB00947)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: phosphate ester of fulvestrant for test arm
Study: NCT05841394
Drug: Esomeprazole 40mg
Normalized name: esomeprazole 40 MG
DrugBank: Esomeprazole (DB00736)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: 40 mg i.v. twice daily (q12h)
Study: NCT05841394
Drug: Ilaprazole Sodium
Normalized name: ilaprazole
DrugBank: Ilaprazole (DB11964)
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 mg i.v. once daily, 20 mg i.v. in the first day.
Study: NCT06768840
Drug: Baricitinib
Normalized name: baricitinib
DrugBank: Baricitinib (DB11817)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: oral baricitinib 4mg for adults and 2mg for children 10-16 years for group A
Study: NCT06319508
Drug: Lidocaine hydrochloride
Normalized name: Lidocaine Hydrochloride
DrugBank: Lidocaine (DB00281)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: The patients were provided with Stellate ganglion block , using 0.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck. Once a day.
Study: NCT04974580
Drug: Nicotine patch
Normalized name: Nicotine Patch
DrugBank: Nicotine (DB00184)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
Study: NCT04789330
Drug: Phenylephrine
Normalized name: Phenylephrine
DrugBank: Phenylephrine (DB00388)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Phenylephrine administered during anesthesia
Study: NCT04762069
Drug: Berubicin
Normalized name: Berubicin
DrugBank: Berubicin (DB17149)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Berubicin HCl is a novel synthetic anthracycline with a chemical structure similar to doxorubicin HCl, a cytotoxic anthracycline topoisomerase II inhibitor isolated from cultures of Streptomyces peucetius var. caesius.
Study: NCT04762069
Drug: Lomustine
Normalized name: Lomustine
DrugBank: Lomustine (DB01206)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Lomustine is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. This medication is classified as an alkylating agent.
Study: NCT05076682
Drug: anti-PD-1 antibody and chemotherapy
Normalized name: Monoclonal antibody anti-SSEA-1
DrugBank: Fanolesomab (DB14211)
Approvals — FDA: no, EMA: no, PMDA: no
Description: PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)
Study: NCT05076682
Drug: Sodium Cromoglicate
Normalized name: Sodium cromoglicate
DrugBank: Sodium citrate (DB09154)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Sodium Cromoglicate will be administered intranasally (nasal spray) (5 spray each nostril 4 times a day, 1 mg/spray)
Study: NCT05076682
Drug: Efavirenz
Normalized name: Efavirenz
DrugBank: Efavirenz (DB00625)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Efavirenz 600mg qd, p.o
Study: NCT05852873
Drug: Nirmatrelvir/ritonavir
Normalized name: NIRMATRELVIR/RITONAVIR
DrugBank: Ritonavir (DB00503)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: Participants in the intervention arm will receive a standard 5-day treatment course Paxlovid (nirmatrelvir plus ritonavir) in addition to standard of care.
Study: NCT04921254
Drug: BSG005 or placebo
Normalized name: INV-CSP #2002 METFORMIN OR PLACEBO
DrugBank: Metformin (DB00331)
Approvals — FDA: yes, EMA: yes, PMDA: no
Description: SAD part is a single IV infusion of ascending doses of BSG005 or placebo - a 30 minutes infusion that may be extended to 2 hours if infusion reactions occur.~The MAD part is single daily infusions of the cohort dose over 30 minutes (that may be delayed up to 2 hours in case of infusion reactions) and which will be repeated daily for 7 days. Objective is safety, tolerability and PK on day 1 and day 7 and to establish steady state plasma level.
Study: NCT03942211
Drug: Selexipag
Normalized name: Selexipag
DrugBank: Selexipag (DB11362)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Oral tablets containing 200 µg of selexipag. Depending on the iMTD, participants will receive 1 (200 µg) to 8 (1600 µg) tablets at each administration
Study: NCT05590455
Drug: Adalimumab Injection
Normalized name: adalimumab Injection
DrugBank: Adalimumab (DB00051)
Approvals — FDA: yes, EMA: yes, PMDA: yes
Description: one sub-cutaneous injection, every 2 weeks for 10 weeks (total 6 injections), started as soon as possible during the first 3 days of antituberculosis treatment and high-dose steroids
Study: NCT05514340
Drug: Normal Saline along with standard treatment
Normalized name: NS-2359
DrugBank: NS-2359 (DB05805)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm normal saline along with standard treatment will be given for active comparison.
Study: NCT05518331
Drug: avatrombopag
Normalized name: AVATROMBOPAG
DrugBank: Avatrombopag (DB11995)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Avatrombopag, 40-60 mg (body weight \< 80 kg, 40 mg per day; body weight \> 80 kg, 60 mg per day) orally once daily for at least 3 months and followed up for 3 months to determine hematological response and evaluate the drug security.
Study: NCT04678648
Drug: RSC-1255 Dose Escalation
Normalized name: peanut allergenic extract
DrugBank: Peanut (DB10553)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Phase 1a will enroll 30-40 participants to identify the dose limiting toxicity (DLT), recommended Phase 1b dose, and the safety and tolerability of RSC-1255. RSC-1255 is administered orally twice daily, without food. Each cycle is 21 days.
Study: NCT04678648
Drug: RSC-1255 Dose Expansion
Normalized name: monofluorophosphate
DrugBank: Monofluorophosphate ion (DB02348)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Phase 1b will enroll 48-104 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily, without food. Each cycle is 21 days.