A Study of Multiple Doses of ALXN2050 in Healthy Adults

NCT ID: NCT05047484

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2019-07-23

Brief Summary

This was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and to evaluate the pharmacokinetics and pharmacodynamics of ACH-0145228 (ALXN2050).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1: 40 mg ALXN2050/Placebo

Participants randomized to receive ALXN2050 or placebo twice daily (BID) on Day 1 through Day 14 in a fasted state.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Powder-in-capsule (PIC).

Placebo

Intervention Type: DRUG

PIC.

Cohort 2: 80 mg ALXN2050/Placebo

Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Powder-in-capsule (PIC).

Placebo

Intervention Type: DRUG

PIC.

Cohort 3: 120 mg ALXN2050/Placebo

Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Powder-in-capsule (PIC).

Placebo

Intervention Type: DRUG

PIC.

Cohort 4: 200 mg ALXN2050/Placebo

Participants randomized to receive ALXN2050 or placebo BID on Day 1 through Day 14 in a fasted state.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Powder-in-capsule (PIC).

Placebo

Intervention Type: DRUG

PIC.

Cohort 5: 120 mg ALXN2050/Placebo

Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fed state.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Powder-in-capsule (PIC).

Placebo

Intervention Type: DRUG

PIC.

Cohort 6: 240 mg ALXN2050/Placebo

Participants randomized to receive a single dose of ALXN2050 or placebo on Day 1 in a fasted state.

Group Type: EXPERIMENTAL

ALXN2050

Intervention Type: DRUG

Powder-in-capsule (PIC).

Placebo

Intervention Type: DRUG

PIC.

Interventions

ALXN2050

Powder-in-capsule (PIC).

Intervention Type: DRUG

Placebo

PIC.

Intervention Type: DRUG

Other Intervention Names

ACH-0145228 (formerly); ACH-5228

Eligibility Criteria

Inclusion Criteria

• Was overtly healthy as determined by medical evaluation including detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
• Had a body weight of at least 50 kilograms (kg) and body mass index within the range of 18 to 30 kg/meter squared (inclusive).
• Male participants were eligible to participate if they agreed to abstinence or use of a highly effective method of contraception.
• Female participants must have been of nonchildbearing potential.

Exclusion Criteria

• Had a history or clinically relevant evidence of current cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disorders or conditions capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
• Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.
• Had a sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicated participation in the study.
• Donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration, or received a blood transfusion or blood products within 6 months prior to first study drug administration.
• Current enrollment or past participation within the last 30 days before study drug administration in any clinical study involving an investigational study intervention or any other type of medical research
• Had clinically significant laboratory abnormalities.
• Positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of screening.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Achillion, a wholly owned subsidiary of Alexion

INDUSTRY

Sponsor Role: collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

ACH228-002

Identifier Type: -

Identifier Source: org_study_id