Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BCX7353 as a Preventative Treatment to Reduce the Frequency of Attacks in Subjects With Hereditary Angioedema
Brief Summary: This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks. Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: CSL312 (low); Type: ACTIVE_COMPARATOR; Interventions: Biological: Factor XIIa antagonist monoclonal antibody | Arm Label: CSL312 (med); Type: ACTIVE_COMPARATOR; Interventions: Biological: Factor XIIa antagonist monoclonal antibody | Arm Label: CSL312 (high); Type: ACTIVE_COMPARATOR; Interventions: Biological: Factor XIIa antagonist monoclonal antibody | Arm Label: CSL312 (med/high); Type: ACTIVE_COMPARATOR; Interventions: Biological: Factor XIIa antagonist monoclonal antibody | Intervention Type: BIOLOGICAL; Name: Factor XIIa antagonist monoclonal antibody; Assigned to Arm(s): CSL312 (high), CSL312 (low), CSL312 (med), CSL312 (med/high) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: SC CINRYZE with rHuPH20 Dose Level 1 followed by Dose Level 2; Type: EXPERIMENTAL; Interventions: Biological: CINRYZE with rHuPH20 | Arm Label: SC CINRYZE with rHuPH20 Dose Level 2 followed by Dose Level 1; Type: EXPERIMENTAL; Interventions: Biological: CINRYZE with rHuPH20 | Intervention Type: BIOLOGICAL; Name: CINRYZE with rHuPH20; Assigned to Arm(s): SC CINRYZE with rHuPH20 Dose Level 1 followed by Dose Level 2, SC CINRYZE with rHuPH20 Dose Level 2 followed by Dose Level 1
C: Arm Label: rhC1INH twice weekly; Type: EXPERIMENTAL; Interventions: Biological: Recombinant human C1 inhibitor | Arm Label: rhC1INH once weekly; Type: EXPERIMENTAL; Interventions: Biological: Recombinant human C1 inhibitor | Arm Label: Placebo (Saline) twice weekly; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: BIOLOGICAL; Name: Recombinant human C1 inhibitor; Assigned to Arm(s): rhC1INH once weekly, rhC1INH twice weekly | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo (Saline) twice weekly
D: Arm Label: Part 1: BCX7353 350 mg once daily; Type: EXPERIMENTAL; Interventions: Drug: BCX7353 | Arm Label: Parts 2 and 3: BCX7353 250 mg once daily; Type: EXPERIMENTAL; Interventions: Drug: BCX7353 | Arm Label: Parts 2 and 3: BCX7353 125 mg once daily; Type: EXPERIMENTAL; Interventions: Drug: BCX7353 | Arm Label: Parts 1, 2 and 3: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Part 3: BCX7353 62.5 mg once daily; Type: EXPERIMENTAL; Interventions: Drug: BCX7353 | Intervention Type: DRUG; Name: BCX7353; Assigned to Arm(s): Part 1: BCX7353 350 mg once daily, Part 3: BCX7353 62.5 mg once daily, Parts 2 and 3: BCX7353 125 mg once daily, Parts 2 and 3: BCX7353 250 mg once daily | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Parts 1, 2 and 3: Placebo

Answer: D