TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05626387
Drug: Prednisolone
Normalized name: Prednisolone
DrugBank: Prednisolone acetate (DB15566)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Prednisolone is a glucocorticoid that suppresses inflammation by several mechanisms.
Study: NCT06148662
Drug: Dental foam Biorepair PERIBIOMA
Normalized name: DIBASIC CALCIUM PHOSPHATE DIHYDRATE 15.11 g in 100 g ORAL PASTE [Biorepair Total Protection]
Approvals — FDA: no, EMA: no, PMDA: no
Description: The participants will be asked to hold 20 ml of coca-cola in their mouth for 30 seconds.~Then, participants will use a dental foam Biorepair PERIBIOMA to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam.
Study: NCT06148662
Drug: Dental spray BUCCOTHERM
Approvals — FDA: no, EMA: no, PMDA: no
Description: The participants will be asked to hold 20 ml of coca-cola in their mouth for 30 seconds.~Then, participants will use a dental spray BUCCOTHERM to rinse their mouth. They should rinse their mouth for 60 seconds and then spit out the foam.
Study: NCT05321732
Drug: DWP16001
Approvals — FDA: no, EMA: no, PMDA: no
Description: DWP16001 A mg
Study: NCT05321732
Drug: DWP202010
Approvals — FDA: no, EMA: no, PMDA: no
Description: DWP202010 B mg
Study: NCT04916613
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: po, b.i.d.
Study: NCT04916613
Drug: Androgen deprivation therapy
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Use according to local standard of care
Study: NCT06347068
Drug: cyclophosphamide
Normalized name: Cyclophosphamide
DrugBank: Cyclophosphamide (DB00531)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: cyclophosphamide 300 mg/m2 IV will be given.
Study: NCT06143462
Drug: Usual care
Approvals — FDA: no, EMA: no, PMDA: no
Description: Include anti-dizziness medications, diuretics, or hormone therapy.
Study: NCT00160745
Drug: Rosuvastatin
Normalized name: Rosuvastatin
DrugBank: Rosuvastatin (DB01098)
Approvals — FDA: yes, EMA: no, PMDA: yes
Study: NCT04933240
Drug: Estradiol
Normalized name: Estradiol
DrugBank: Estradiol acetate (DB13952)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: estradiol tablets for oral administration contains 1 mg of micronized estradiol per tablet.
Study: NCT04933240
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: A sugar tablet that does not contain any active medicine
Study: NCT06218056
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: The placebo softgel capsule formulation will have a composition with the same relative proportions as the CBD ATL5 Softgel Capsules. This formulation will be manufactured by Baxco Pharmaceutical Inc under cGMP conditions. 4 softgel capsules of placebo will be administered to match the capsule number of the active compound, daily in the morning and evening for each of 56 days.
Study: NCT04628481
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral placebo twice a day for 13 cycles
Study: NCT05155293
Drug: Eylea® (Aflibercept)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients will receive IVT injections of Eylea®
Study: NCT06679322
Drug: Androtriol Injection (High-dose group)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will receive 30 mL of Androtriol Injection per dose, administered every 12 hours for 7 consecutive days. Each infusion will be administered over a period of 30±5 minutes.
Study: NCT05489796
Drug: Fentanyl selector
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Selector (1 ml; Lock out 10 min): Fentanyl 200 mcg + N/S 16 ml = total 20 ml
Study: NCT05489796
Drug: Fentanyl continuous
Normalized name: Fentanyl
DrugBank: Fentanyl (DB00813)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Continuous (2 ml/hr): fentanyl 700 mcg + N/S 86 ml = total 100 ml
Study: NCT05489796
Drug: Ketorolac continuous
Approvals — FDA: no, EMA: no, PMDA: no
Description: Continuous (2 ml/hr): Ketorolac 180 mg + N/S 94 ml = total 100 ml
Study: NCT04973800
Drug: Simvastatin 20mg
Normalized name: SIMVASTATIN 20MG TAB
DrugBank: Simvastatin (DB00641)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Simvastatin 20mg ON PO for 28-30 days
Study: NCT05634707
Drug: Fluoxetine
Normalized name: Fluoxetine
DrugBank: Fluoxetine (DB00472)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Patients randomized to the experimental arm will receive fluoxetine 20mg/day for 5 days before escalation to a maintenance dose at day 6. On day 6, patients will start treatment with 50 mg/m2 TMZ daily for 7 days (Days 6-12)~* Arm 2A (n=10) - Escalate to maintenance 40mg/day fluoxetine on day 6~* Arm 2B (n=10) - This arm will be opened as long as there are less than 3/10 dose limiting toxicities in Arm 2A. Patients will escalate to maintenance 60mg/day fluoxetine on day 6
Study: NCT05556226
Drug: ABBV-154 Dose Formulation B
Normalized name: Hep B, unspecified formulation
Approvals — FDA: no, EMA: no, PMDA: no
Description: Subcutaneous Injection
Study: NCT05347394
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo matched to VX-708 for oral administration.
Study: NCT02371096
Drug: RGB-03
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT05108259
Drug: PBP1502
Approvals — FDA: no, EMA: no, PMDA: no
Description: 40 mg/0.4 mL single SC injection via PFS
Study: NCT05108259
Drug: EU-licensed Humira
Approvals — FDA: no, EMA: no, PMDA: no
Description: 40 mg/0.4 mL single SC injection via PFS
Study: NCT05108259
Drug: US-licensed Humira
Approvals — FDA: no, EMA: no, PMDA: no
Description: 40 mg/0.4 mL single SC injection via PFS
Study: NCT05615272
Drug: Alveogyl
Approvals — FDA: no, EMA: no, PMDA: no
Description: Control group
Study: NCT04676646
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo comparator
Study: NCT06214637
Drug: Melissa
Normalized name: Indian melissa oil
Approvals — FDA: no, EMA: no, PMDA: no
Description: The test solutions will be administered once a day through administration in drops for children between 5 and 10 years old and for adolescents between 11 and 16 years old. As participants will be between 5 and 16 years old, children will be given a minimum of 5 and a maximum of 10 drops of the solutions per individual (Tavares-Silva, Holandino et al. 2019) as well as a maximum of 10 drops for adolescents of solutions per individual (Taylor, Lancaster et al. 2000). Highlighting that the prescription of Melissa officinalis will be at night, around 20/30 minutes before bedtime, respecting the indications for the medications described in the Hahnemannian Materia Medica (Vijnovsky, 2003). All medications must be taken away from meals and they will be instructed not to use mentholated substances, respecting a minimum time of 30 minutes.
Study: NCT06214637
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: It will be administered for a period of 30 days, once a day before bed, with a 15-day wash-out interval. The placebo, a drug without active substance, that will be administered to research participants will be the biotherapeutic vehicle, that is, 30% alcohol (v/v), which is commonly used as a vehicle for homeopathic medicines.
Study: NCT02978651
Drug: Placebo Oral Tablet
Normalized name: placebo ORAL TABLET
Approvals — FDA: no, EMA: no, PMDA: no
Study: NCT04832776
Drug: FOLFOXIRI
Approvals — FDA: no, EMA: no, PMDA: no
Description: FOLFOXIRI
Study: NCT06036927
Drug: TQC2731 injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: TQC2731 injection is a thymic stromal lymphopoietin (TSLP) monoclonal antibody.
Study: NCT06036927
Drug: TQC2731 matching placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: It'a a placebo injection without active substances.
Study: NCT05856058
Drug: SHR0302
Approvals — FDA: no, EMA: no, PMDA: no
Description: SHR0302 oral solution 1 time, SHR0302 tablets 1 time
Study: NCT05522634
Drug: TJAOA101
Approvals — FDA: no, EMA: no, PMDA: no
Description: Once enrolled, participants will be administrated TJAOA101
Study: NCT04694703
Drug: Covid-19 group
Normalized name: covid-19, protein subunit
Approvals — FDA: no, EMA: no, PMDA: no
Description: Routine COVID-19 treatment
Study: NCT05922709
Drug: CS12192 capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants receive CS12192 orally single or multiple doses
Study: NCT05922709
Drug: Placebo capsule
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants receive placebo matching CS12192 orally single or multiple doses
Study: NCT05974033
Drug: Medical therapy alone
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation.
Study: NCT04334408
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo injections during the run in and washout serves as the control condition. Both the subject and the investigator will be blinded to the timing of transition to and from placebo and the transition to and from fremanezumab.
Study: NCT03649464
Drug: OKN-007
Approvals — FDA: no, EMA: no, PMDA: no
Description: Dose escalation/PK cohort (Phase Ib): 1000mg twice daily (BID), 1000mg thrice daily (TID), 1500mg thrice daily (TID).~Expansion cohort (Phase 2): MTD defined in the dose escalation (Phase Ib) study.
Study: NCT06526793
Drug: AZD0486
Approvals — FDA: no, EMA: no, PMDA: no
Description: Investigational Product administered via intravenous infusion.
Study: NCT05289557
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sugar pills with no active ingredients. Minimum 1 tablet at bedtime. Up to two pills daily (one tablet in the morning and one tablet at bedtime). The treatment duration is 15 days.
Study: NCT05425745
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: placebo tablet made to resemble active
Study: NCT06678113
Drug: BSG005
Approvals — FDA: no, EMA: no, PMDA: no
Description: Single arm dose escalation in patients with invasive fungal infection
Study: NCT06087276
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Once daily oral treatment
Study: NCT06678685
Drug: .spironolactone
Approvals — FDA: no, EMA: no, PMDA: no
Description: In the first week, the starting dose is 2mg/Kg per body weight once a day, taken with food at lunch every day, and subsequently adjusted according to the situation. If the patient's serum potassium is ≤5.0 mEq/L and the patient's serum creatinine is ≤2.5 mg/dL, treatment should be initiated with 25 mg spironolactone once daily. Increased to 100mg after remission. If the results are not obvious in the first month, increase the drug dose to 3mg/Kg.
Study: NCT05848440
Drug: AZD9550
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will be administered AZD9550 subcutaneously.
Study: NCT05848440
Drug: AZD9550
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will be administered AZD9550 intravenously.
Study: NCT05848440
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will be administered matching volumes of placebo subcutaneously or intravenously.
Study: NCT04873869
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Administered orally
Study: NCT04899921
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Taken orally
Study: NCT05597839
Drug: DF9001
Approvals — FDA: no, EMA: no, PMDA: no
Description: Immunotherapy agent targeting NK cells.
Study: NCT05597839
Drug: KEYTRUDA®
Approvals — FDA: no, EMA: no, PMDA: no
Description: Anti-PD-1 immunotherapy agent
Study: NCT04856774
Drug: SHR-1701；BP102
Approvals — FDA: no, EMA: no, PMDA: no
Description: Drug: SHR-1701 IV infusion~Drug: BP102 IV infusion~Phase Ib: SHR-1701 30mg/kg + BP102 15mg/kg Q3w as starting dose, until recommended phase 2 dose is determined.
Study: NCT06277050
Drug: Maintenance Therapy with Toripalimab and Capecitabine
Normalized name: Toripalimab
DrugBank: Toripalimab (DB15043)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. Maintenance therapy of Toripalimab (240 mg, every 3 weeks). The total treatment time of oral chemotherapy is 12 months.
Study: NCT06277050
Drug: Maintenance Therapy with Capecitabine
Normalized name: Capecitabine
DrugBank: Capecitabine (DB01101)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. The total treatment time of oral chemotherapy is 12 months.
Study: NCT05719831
Drug: vonoprazan fumarate + low dose amoxicillin（L-10d)
Approvals — FDA: no, EMA: no, PMDA: no
Description: vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin1000mg/ time, 2 times/day, oral, for 10d
Study: NCT05719831
Drug: vonoprazan fumarate + amoxicillin（H-14d)
Approvals — FDA: no, EMA: no, PMDA: no
Description: vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 14d
Study: NCT06616389
Drug: ODX (Osteodex)
Approvals — FDA: no, EMA: no, PMDA: no
Description: Multi-center, prospective, open-label, ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX.
Study: NCT06663631
Drug: Placebo group
Approvals — FDA: no, EMA: no, PMDA: no
Description: 50 ml saline solution was set as placebo and delivered intravenously at the beginning of endovascular thrombectomyat a velocity of 4ml/h. The whole period of drug delivery lasts for approximately 12h.
Study: NCT04770012
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: patients randomized to placebo study group will be dispensed placebo capsules to be taken daily for the duration of the treatment
Study: NCT06012578
Drug: ISM5411
Approvals — FDA: no, EMA: no, PMDA: no
Description: Investigational Drug
Study: NCT06012578
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: ISM5411 Matching Placebo
Study: NCT06019117
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: clinical trial using 90 days of placebo controlled
Study: NCT06744751
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Manufactured by the same company, the placebo capsules contain starch as the main ingredient and are identical in appearance, size, color, dosage form, weight, and taste to the FMT capsules. They are administered once daily, 4 capsules per dose, for 12 days.
Study: NCT06001762
Drug: LHRH Agonist
Approvals — FDA: no, EMA: no, PMDA: no
Description: Luteinizing hormone-releasing hormone agonist), taken orally per institutional standard of care
Study: NCT06678282
Drug: JY231 Injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: The starting dose of this study was set at 1\~10×10\^6 transduction units (TU) / kg and escalated at 2\~5×107\^TU/kg and 6\~10×10\^7 TU/kg.
Study: NCT06650124
Drug: Mycophenolate Mofetil + Prednisolone Participants will receive mycophenolate mofetil in combination.
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants in this arm will receive mycophenolate mofetil (MMF) starting at 1,000 mg/day for the first two weeks, increasing to 2,000 mg/day thereafter. This will be combined with prednisolone, beginning at 40-60 mg/day, with a tapering dose to 5-10 mg/day after 4-8 weeks, depending on the patient's response. MMF works by inhibiting inosine monophosphate dehydrogenase, which decreases lymphocyte proliferation, thereby reducing immune-mediated liver damage in autoimmune hepatitis. Prednisolone, a corticosteroid, is included to control inflammation during the induction phase of treatment. This intervention lasts for 24 weeks, with monitoring for biochemical remission (normalization of liver enzymes and IgG levels) and adverse events to assess the treatment's safety and efficacy.
Study: NCT06650124
Drug: Azathioprine + Prednisolone
Normalized name: Azathioprine
DrugBank: Azathioprine (DB00993)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: In this arm, participants will receive azathioprine (AZA) starting at 50 mg/day for the first two weeks, followed by an increase to 100 mg/day. This dose will be combined with prednisolone, starting at 40-60 mg/day, with the dosage tapering to 5-10 mg/day after 4-8 weeks, depending on patient response. Azathioprine works as an immunosuppressive agent by inhibiting DNA synthesis in rapidly dividing immune cells, thereby reducing liver inflammation in autoimmune hepatitis. Prednisolone, a corticosteroid, is included to control inflammation during the initial treatment phase. The intervention lasts for 24 weeks with regular monitoring for biochemical remission, defined as normalization of liver enzymes (AST, ALT) and IgG levels, as well as the occurrence of adverse events to assess safety and tolerability.
Study: NCT03417206
Drug: Remifentanil
Normalized name: Remifentanil
DrugBank: Remifentanil (DB00899)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
Study: NCT05010577
Drug: BX004-A
Approvals — FDA: no, EMA: no, PMDA: no
Description: Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa
Study: NCT05010577
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Nebulized placebo
Study: NCT05706844
Drug: Spinal anesthesia
Normalized name: Bos taurus spinal cord preparation
Approvals — FDA: no, EMA: no, PMDA: no
Description: plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal
Study: NCT05706844
Drug: General anaesthesia
Approvals — FDA: no, EMA: no, PMDA: no
Description: Propofol (induction: 1.0-2.0 mg/kg. infusion: 3-5 mg/kg/hour) + Remifentanil (induction: 3-5 mcg/kg, infusion: 0.5 mcg/kg/min) given intravenously
Study: NCT04608630
Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj
Normalized name: ZOLEDRONIC ACID 5MG/BAG 100ML INJ
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride or 5% Dextrose, administered via intravenous infusion over at least 15 minutes on Study Day 1.
Study: NCT06427044
Drug: Anterior serratus block group
Normalized name: Fucus serratus extract
Approvals — FDA: no, EMA: no, PMDA: no
Description: Bupivacaine lipid 20mL (20mL 266mg bupivacaine liposomes) was ultrasound-guided for a single anterior serranus plane block
Study: NCT04954859
Drug: Bepirovirsen
Approvals — FDA: no, EMA: no, PMDA: no
Description: No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.
Study: NCT04954859
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: No study drug will be administered in this study. Eligible participants who received prior treatment with placebo in the parent studies (209668, 202009, and 219288) will be included to maintain the blind in the still ongoing parent studies.
Study: NCT04913519
Drug: TDM-105795
Approvals — FDA: no, EMA: no, PMDA: no
Description: TDM-105795 topical solution
Study: NCT04913519
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo for TDM-105795 topical solution
Study: NCT05782608
Drug: IV ibuprofen
Normalized name: Ibuprofen
DrugBank: Ibuprofen (DB01050)
Approvals — FDA: yes, EMA: no, PMDA: yes
Description: Group 1 will receive IV ibuprofen 400mg \\ 6 hours the first dose will be administrated immediately post operative.
Study: NCT05782608
Drug: IV ketorolac
DrugBank: Ketorolac (DB00465)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: Group 2 will receive 20 mg IV ketorolac\\ 6 hours the first dose will be administrated immediately post operative
Study: NCT04684511
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Matching Placebo
Study: NCT05903339
Drug: V3G CH848 Pr-NP1 60mcg
Normalized name: Bacillus anthracis strain V770-NP1-R antigens Injectable Suspension [Biothrax]
Approvals — FDA: no, EMA: no, PMDA: no
Description: (60 mcg)
Study: NCT05903339
Drug: 3M-052-AF 5mcg
Normalized name: Canesten AF
Approvals — FDA: no, EMA: no, PMDA: no
Description: (5 mcg)
Study: NCT05903339
Drug: ACU-026-001-1 2.0mg
Approvals — FDA: no, EMA: no, PMDA: no
Description: (2.0 mg)
Study: NCT05903339
Drug: V3G CH848 Pr-NP1 100mcg
Normalized name: Bacillus anthracis strain V770-NP1-R antigens Injectable Suspension [Biothrax]
Approvals — FDA: no, EMA: no, PMDA: no
Description: (100 mcg)
Study: NCT04410224
Drug: ASN004
Approvals — FDA: no, EMA: no, PMDA: no
Description: ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors.
Study: NCT04475276
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Lifestyle modification with placebo for 12 weeks
Study: NCT05945810
Drug: TLL-018 extended-release tablet
Approvals — FDA: no, EMA: no, PMDA: no
Description: 50mg TLL-018 extended-release tablet QD
Study: NCT04282239
Drug: Lidocaine Epinephrine
Normalized name: epinephrine / lidocaine
Approvals — FDA: no, EMA: no, PMDA: no
Description: 10 mL on each side of anterior chest for a total of 20mL
Study: NCT05367635
Drug: SKB315 for injection
Approvals — FDA: no, EMA: no, PMDA: no
Description: SKB315 for injection is an Antibody Drug Conjugates (ADC) drug targeting Claudin18.2. The strength of SKB315 is 200 mg/vial.
Study: NCT04832971
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Sterile Normal Saline (0.9% NaCl)
Study: NCT05152901
Drug: EpiPen ®.
Approvals — FDA: no, EMA: no, PMDA: no
Description: A single dose of 0.3 mg epinephrine via intramuscular injection into the anterolateral aspect of the thigh on Day 1 Visit 2.
Study: NCT05152901
Drug: Epinephrine (0.3mg) inhaled
Normalized name: epinephrine Inhalation Powder
Approvals — FDA: no, EMA: no, PMDA: no
Description: Participants will be administered 0.3mg of first inhaled dose of epinephrine once daily on day 2 of Visit 2
Study: NCT05152901
Drug: Epinephrine (1.3mg)
Normalized name: Epinephrine
DrugBank: Epinephrine (DB00668)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 1.3 mg epinephrine.
Study: NCT05152901
Drug: Epinephrine (4mg)
Normalized name: Epinephrine
DrugBank: Epinephrine (DB00668)
Approvals — FDA: yes, EMA: no, PMDA: no
Description: A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 4 mg epinephrine
Study: NCT05120687
Drug: noncorticosteroid systemic immunomodulatory therapy (NCSIT)
Normalized name: Monistat Simple Therapy
Approvals — FDA: no, EMA: no, PMDA: no
Description: Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate 15mg/week or Adalimumab 40mg /2weeks or Mycophenolate Mofetil 1g/day or Cyclosporin 50mg-100mg/day or cyclophosphamide 10mg/kg on two consecutive days every 2 weeks.
Study: NCT05592990
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Placebo MP
Study: NCT04747795
Drug: Normal saline
Normalized name: Normal Saline Flush
Approvals — FDA: no, EMA: no, PMDA: no
Description: IV
Study: NCT05923866
Drug: Placebo
Normalized name: placebo
Approvals — FDA: no, EMA: no, PMDA: no
Description: Oral administration of placebo once a daily for 24 weeks
Study: NCT05385575
Drug: KN056 (0.1mg)
Approvals — FDA: no, EMA: no, PMDA: no
Description: The participants will receive assigned single dose of KN056 on Day 1