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Also known as SHP623
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 |
| 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 | BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
Recombinant human C1 esterase inhibitor is being developed for hereditary angioedema (HAE), a rare immunological condition characterized by recurrent swelling attacks. It is an investigational therapy and has been studied in a Phase 1 clinical trial in healthy adult subjects to assess safety, tolerability, and pharmacokinetics.
Recombinant human C1 esterase inhibitor targets factor IX (F9). It is an exogenous protein designed to supplement C1 esterase inhibitor activity. By targeting F9, it is intended to modulate the complement and coagulation pathways involved in hereditary angioedema.
Recombinant human C1 esterase inhibitor is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is responsible for the clinical development of this investigational therapy for hereditary angioedema.
Recombinant human C1 esterase inhibitor is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 trial has been completed, and no active trials are currently listed.
Recombinant human C1 esterase inhibitor has been evaluated in a single completed Phase 1 trial, NCT02663687. This randomized, double-blind, placebo-controlled study assessed the safety, tolerability, and pharmacokinetics of the drug in 48 healthy adult subjects in the United States.