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Recombinant human C1 esterase inhibitor · 1 trial · 1 indication
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE was considered to be a TEAE in a specific treatment period of the study if the date and time of onset were after investigational product administration in that period and if it occurred less than equals to (\<=) Day 28 and was both not present at the start of that period and was not a chronic condition that was part of the participant's medical history, or it was present at the start of that period or as part of the participant's medical history but the severity or frequency increased during that period \<= Day 28. An SAE was defined as any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose.
| Arm | Type | Description |
|---|---|---|
| Treatment 1- 4 | EXPERIMENTAL | Treatment A: 9 Subjects will receive dose level I of SHP623 intravenously (IV). B: 9 Subjects will receive dose level I of SHP623 subcutaneously(SC). |
| Placebo | PLACEBO_COMPARATOR | 3 Subjects will receive placebo for each cohort |
| Name | Type | Description |
|---|---|---|
| Recombinant human C1 esterase inhibitor | DRUG | Subjects will receive escalating doses I-IV as both IV and SC injections |
| Placebo | DRUG | Subjects will receive matching placebo |
| SHP623 | DRUG | SHP623 |
Inclusion Criteria: 1. Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease 2. Male, or non-pregnant, non-lactating female, who agrees to comply with any applicable contraceptive requirements of the protocol, or females of non-child-bearing p...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Intellia Therapeutics, Inc. | NTLA | 3 | PHASE3 | NTLA-2002, Normal Saline Administration |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | Dose 1 of BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
Recombinant human C1 esterase inhibitor is an investigational therapy being studied for the treatment of Hereditary Angioedema (HAE), a condition characterized by recurrent episodes of severe swelling. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Recombinant human C1 esterase inhibitor is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is listed on the stock exchange under the ticker symbol TAK.
Recombinant human C1 esterase inhibitor is currently in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The Phase 1 study has been completed, and the drug remains under investigation for Hereditary Angioedema.
Recombinant human C1 esterase inhibitor has one completed Phase 1 clinical trial, identified as NCT02663687. This study assessed the safety, tolerability, and pharmacokinetics of the drug in healthy adult subjects in the United States. The trial enrolled 48 participants and was randomized, double-blind, and placebo-controlled.
Recombinant human C1 esterase inhibitor is a specific form of C1 esterase inhibitor that is produced using recombinant technology. It is being studied for use in Hereditary Angioedema. The drug is distinct from plasma-derived C1 esterase inhibitors, though it serves a similar therapeutic purpose.